Trial Outcomes & Findings for Skin bioMARkers for Atopic Eczema Therapy Evaluation (NCT NCT04194814)
NCT ID: NCT04194814
Last Updated: 2025-07-18
Results Overview
The difference in the change in epidermal thickness, measured by structural OCT, between the sites treated with crisaborole (2%) ointment and betamethasone valerate (0.1%) cream.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
Day 1 - Day 57
Results posted on
2025-07-18
Participant Flow
Recruitment started 20/11/2020 and ended 27/07/2021. 37 participants were recruited. Recruitment was conducted by the Sheffield Dermatology Research Group in several ways: General advertisement using posters. Email lists. Outpatient contact including local GP practices.
Some participants, who were currently using treatments for eczema, needed to undergo a 'wash out' period, where the use of these treatments was stopped, prior to the first study visit. The duration of the wash-out depended on the type of treatment, and varied from 7 days for emollients to 12 weeks for intravenous biologic therapies.
Participant milestones
| Measure |
Betamethasone Valerate (0.1%) Cream LEFT/Crisaborole (2%) Ointment RIGHT
All participants who treated the left forearm with Betamethasone valerate (0.1%) cream and the right forearm with Crisaborole (2%) ointment. Twice daily application for 4 weeks (randomised site allocation).
|
Crisaborole (2%) Ointment LEFT/Betamethasone Valerate (0.1%) Cream RIGHT
All participants who treated the left forearm with Crisaborole (2%) ointment and the right forearm with Betamethasone valerate (0.1%) cream. Twice daily for 4 weeks (randomised site allocation).
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
|
Overall Study
COMPLETED
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Betamethasone Valerate (0.1%) Cream LEFT/Crisaborole (2%) Ointment RIGHT
All participants who treated the left forearm with Betamethasone valerate (0.1%) cream and the right forearm with Crisaborole (2%) ointment. Twice daily application for 4 weeks (randomised site allocation).
|
Crisaborole (2%) Ointment LEFT/Betamethasone Valerate (0.1%) Cream RIGHT
All participants who treated the left forearm with Crisaborole (2%) ointment and the right forearm with Betamethasone valerate (0.1%) cream. Twice daily for 4 weeks (randomised site allocation).
|
|---|---|---|
|
Overall Study
Physician Decision
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Enrolled
n=37 Participants
All enrolled participants
|
|---|---|
|
Age, Continuous
|
29.4 years
STANDARD_DEVIATION 12.09 • n=37 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=37 Participants
|
|
Region of Enrollment
United Kingdom
|
37 participants
n=37 Participants
|
|
Atopic dermatitis as defined by UK working party diagnostic criteria
|
37 Participants
n=37 Participants
|
PRIMARY outcome
Timeframe: Day 1 - Day 57The difference in the change in epidermal thickness, measured by structural OCT, between the sites treated with crisaborole (2%) ointment and betamethasone valerate (0.1%) cream.
Outcome measures
| Measure |
Betamethasone Valerate (0.1%) Cream
n=32 Participants
All sites (left or right) treated with Betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment
n=32 Participants
All sites (left or right) treated with Crisaborole (2%) ointment.
|
Betamethasone Valerate (0.1%) Cream Without FLG Mutation
All participants without a FLG mutation who treated with betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment Without FLG Mutation
All participants without a FLG mutation who treated with crisaborole (2%) ointment.
|
|---|---|---|---|---|
|
Change in Epidermal Thickness
Day 29 to Day 57
|
24.94 µm
Interval 21.39 to 28.5
|
11.63 µm
Interval 8.07 to 15.19
|
—
|
—
|
|
Change in Epidermal Thickness
Day 1 to Day 29
|
-31.66 µm
Interval -35.31 to -28.01
|
-13.76 µm
Interval -17.42 to -10.1
|
—
|
—
|
|
Change in Epidermal Thickness
Day 1 to Day 15
|
-28.65 µm
Interval -31.58 to -25.73
|
-14.41 µm
Interval -17.35 to -11.48
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 15, Day 29 and Day 57Population: 35 participants had complete data at Day 1. Each participant was expected to complete 56 days of treatment. A total of 5 participants were withdrawn before this point and so only 32 participants had data available for analysis at Day 29 and 57.
Analysis of the difference in the change in skin redness/erythema (relating to tolerability) during and after 28 days treatment determined by Mexameter measured on day 1, day 15, day 29 and day 57. The Mexameter device has a range of 0-999AU (arbitrary units) and the lower the value, the better the condition of the skin. Objective redness can be classified using the following scale: 0-170AU - No erythema; 170-330AU - Minimal erythema; 330-450AU - Diffuse erythema; 450-570AU - High erythema; over 570AU - Extreme erythema
Outcome measures
| Measure |
Betamethasone Valerate (0.1%) Cream
n=35 Participants
All sites (left or right) treated with Betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment
n=35 Participants
All sites (left or right) treated with Crisaborole (2%) ointment.
|
Betamethasone Valerate (0.1%) Cream Without FLG Mutation
All participants without a FLG mutation who treated with betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment Without FLG Mutation
All participants without a FLG mutation who treated with crisaborole (2%) ointment.
|
|---|---|---|---|---|
|
Analysis of Change in Objective Erythema
Baseline to Day 29
|
-27.61 AU
Interval -43.48 to -11.73
|
-1.16 AU
Interval -17.04 to 14.72
|
—
|
—
|
|
Analysis of Change in Objective Erythema
Baseline to Day 15
|
-45.04 AU
Interval -59.08 to -31.01
|
-23.61 AU
Interval -37.65 to -9.57
|
—
|
—
|
|
Analysis of Change in Objective Erythema
Day 29 to Day 57
|
37.66 AU
Interval 22.8 to 52.51
|
2.84 AU
Interval -12.02 to 17.69
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 15, Day 29 and Day 57Population: 35 participants had complete data at Day 1. Each participant was expected to complete 56 days of treatment. A total of 5 participants were withdrawn before this point and so only 32 participants had data available for analysis at Day 29 and 57.
Analysis of the change in Trans-Epidermal Water Loss (TEWL, relates to skin barrier function) during and after treatment. TEWL measurements on day 1, day 15, day 29 and day 57.
Outcome measures
| Measure |
Betamethasone Valerate (0.1%) Cream
n=35 Participants
All sites (left or right) treated with Betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment
n=35 Participants
All sites (left or right) treated with Crisaborole (2%) ointment.
|
Betamethasone Valerate (0.1%) Cream Without FLG Mutation
All participants without a FLG mutation who treated with betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment Without FLG Mutation
All participants without a FLG mutation who treated with crisaborole (2%) ointment.
|
|---|---|---|---|---|
|
TEWL - Skin Barrier Function
Baseline to Day 29
|
-0.52 g/m²/h
Interval -1.62 to 0.59
|
2.06 g/m²/h
Interval 0.96 to 3.16
|
—
|
—
|
|
TEWL - Skin Barrier Function
Baseline to Day 15
|
-0.92 g/m²/h
Interval -1.74 to -0.11
|
1.66 g/m²/h
Interval 0.85 to 2.48
|
—
|
—
|
|
TEWL - Skin Barrier Function
Day 29 to Day 57
|
2.25 g/m²/h
Interval 0.79 to 3.72
|
0.21 g/m²/h
Interval -1.26 to 1.67
|
—
|
—
|
SECONDARY outcome
Timeframe: on Day 29, after 28 days treatmentPopulation: Full Analysis Set
The difference in skin barrier integrity (TEWLts20) after 28 days treatment. TEWL measurements after tape-stripping (TEWLts20) on day 29
Outcome measures
| Measure |
Betamethasone Valerate (0.1%) Cream
n=32 Participants
All sites (left or right) treated with Betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment
n=32 Participants
All sites (left or right) treated with Crisaborole (2%) ointment.
|
Betamethasone Valerate (0.1%) Cream Without FLG Mutation
All participants without a FLG mutation who treated with betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment Without FLG Mutation
All participants without a FLG mutation who treated with crisaborole (2%) ointment.
|
|---|---|---|---|---|
|
TEWL - After Tape-stripping
|
45.4 g/m²/h
Standard Deviation 23.01
|
34.1 g/m²/h
Standard Deviation 14.67
|
—
|
—
|
SECONDARY outcome
Timeframe: on Day 29, after 28 days treatmentPopulation: Full Analysis Set
The difference in skin barrier integrity (TEWLts20) after 28 days treatment. TEWL measurements after tape-stripping (TEWLts20) on day 29
Outcome measures
| Measure |
Betamethasone Valerate (0.1%) Cream
n=32 Participants
All sites (left or right) treated with Betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment
n=32 Participants
All sites (left or right) treated with Crisaborole (2%) ointment.
|
Betamethasone Valerate (0.1%) Cream Without FLG Mutation
All participants without a FLG mutation who treated with betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment Without FLG Mutation
All participants without a FLG mutation who treated with crisaborole (2%) ointment.
|
|---|---|---|---|---|
|
Comparison of TEWL - After Tape-stripping
|
45.44 g/m²/h
Interval 37.14 to 53.74
|
34.13 g/m²/h
Interval 28.84 to 39.42
|
—
|
—
|
SECONDARY outcome
Timeframe: Visual skin dryness scored on day 1, day 15, day 29 and day 57Population: Frequency of visual dryness scores on Day 1, Day 15, Day 29 and Day 57.
The difference in the change in visual skin dryness during and after treatment. Visual skin dryness scored on day 1, day 15, day 29 and day 57. Visual skin dryness was scored using the following: 0 - Absent; 1 - Faint scaling, faint roughness and dull appearance; 2 - Small scales in combination with a few larger scales, slight roughness, whitish appearance; 3 - Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks; 4 - Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks. The lower the visual dryness score, the better the condition of the skin.
Outcome measures
| Measure |
Betamethasone Valerate (0.1%) Cream
n=37 Participants
All sites (left or right) treated with Betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment
n=37 Participants
All sites (left or right) treated with Crisaborole (2%) ointment.
|
Betamethasone Valerate (0.1%) Cream Without FLG Mutation
All participants without a FLG mutation who treated with betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment Without FLG Mutation
All participants without a FLG mutation who treated with crisaborole (2%) ointment.
|
|---|---|---|---|---|
|
Skin Dryness
Day 1 · 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Skin Dryness
Day 15 · 0
|
34 Participants
|
35 Participants
|
—
|
—
|
|
Skin Dryness
Day 1 · 0
|
36 Participants
|
35 Participants
|
—
|
—
|
|
Skin Dryness
Day 1 · 1
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Skin Dryness
Day 15 · 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Skin Dryness
Day 15 · 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Skin Dryness
Day 29 · 0
|
30 Participants
|
31 Participants
|
—
|
—
|
|
Skin Dryness
Day 29 · 1
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Skin Dryness
Day 29 · 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Skin Dryness
Day 57 · 0
|
28 Participants
|
29 Participants
|
—
|
—
|
|
Skin Dryness
Day 57 · 1
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Skin Dryness
Day 57 · 2
|
1 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: Full Analysis Set
The difference in Natural Moisturising Factor (NMF, filaggrin breakdown products) levels at the end of treatment. 3 NMF components were measured: Urocanic acid (UCA), Pyrrolidone carboxylic acid (PCA) and Free amino acids (FAA) and are expressed together as total NMF (tNMF).
Outcome measures
| Measure |
Betamethasone Valerate (0.1%) Cream
n=32 Participants
All sites (left or right) treated with Betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment
n=32 Participants
All sites (left or right) treated with Crisaborole (2%) ointment.
|
Betamethasone Valerate (0.1%) Cream Without FLG Mutation
All participants without a FLG mutation who treated with betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment Without FLG Mutation
All participants without a FLG mutation who treated with crisaborole (2%) ointment.
|
|---|---|---|---|---|
|
Natural Moisturising Factor (NMF)
Total Natural Moisturising Factors (NMF)
|
1.299 moles/µg protein
Standard Deviation 0.6080
|
1.331 moles/µg protein
Standard Deviation 0.5885
|
—
|
—
|
|
Natural Moisturising Factor (NMF)
Pyrrolidone Carboxylic Acid (PCA)
|
0.156 moles/µg protein
Standard Deviation 0.844
|
0.157 moles/µg protein
Standard Deviation 0.0708
|
—
|
—
|
|
Natural Moisturising Factor (NMF)
Urocanic Acid (UCA)
|
0.032 moles/µg protein
Standard Deviation 0.0218
|
0.039 moles/µg protein
Standard Deviation 0.0208
|
—
|
—
|
|
Natural Moisturising Factor (NMF)
Free Amino Acids (FAA)
|
1.111 moles/µg protein
Standard Deviation 0.5164
|
1.135 moles/µg protein
Standard Deviation 0.5215
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: Full Analysis Set
The difference in Natural Moisturising Factor (NMF, filaggrin breakdown products) levels at the end of treatment. 3 NMF components were measured: Urocanic acid (UCA), Pyrrolidone carboxylic acid (PCA) and Free amino acids (FAA) and are expressed together as total NMF (tNMF).
Outcome measures
| Measure |
Betamethasone Valerate (0.1%) Cream
n=32 Participants
All sites (left or right) treated with Betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment
n=32 Participants
All sites (left or right) treated with Crisaborole (2%) ointment.
|
Betamethasone Valerate (0.1%) Cream Without FLG Mutation
All participants without a FLG mutation who treated with betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment Without FLG Mutation
All participants without a FLG mutation who treated with crisaborole (2%) ointment.
|
|---|---|---|---|---|
|
Comparison of Natural Moisturising Factor (NMF) Between Treatments
Pyrrolidone Carboxylic Acid (PCA)
|
0.156 nmoles/µg protein
Interval 0.125 to 0.186
|
0.157 nmoles/µg protein
Interval 0.131 to 0.182
|
—
|
—
|
|
Comparison of Natural Moisturising Factor (NMF) Between Treatments
Total Natural Moisturising Factors (NMF)
|
1.299 nmoles/µg protein
Interval 1.08 to 1.518
|
1.331 nmoles/µg protein
Interval 1.119 to 1.543
|
—
|
—
|
|
Comparison of Natural Moisturising Factor (NMF) Between Treatments
Urocanic Acid (UCA)
|
0.032 nmoles/µg protein
Interval 0.024 to 0.04
|
0.039 nmoles/µg protein
Interval 0.031 to 0.046
|
—
|
—
|
|
Comparison of Natural Moisturising Factor (NMF) Between Treatments
Free Amino Acids (FAA)
|
1.111 nmoles/µg protein
Interval 0.925 to 1.297
|
1.135 nmoles/µg protein
Interval 0.947 to 1.323
|
—
|
—
|
SECONDARY outcome
Timeframe: Visual skin redness scored on day 1, day 15, day 29 and day 57Population: Frequency of visual dryness scores on Day 1, Day 15, Day 29 and Day 57.
The difference in the change in visual skin redness during and after treatment. Visual skin redness scored on day 1, day 15, day 29 and day 57 by an experienced grader. Visual skin redness was scored using the following: 0 - No redness; 0.5/+ - Slight patchy erythema, barely perceptible; 1 - Slight uniform erythema, mild erythema; 2 - Moderate uniform erythema, moderate erythema; 3 - Strong erythema, marked erythema. The higher the visual redness score, the more inflamed the skin looks to the naked eye.
Outcome measures
| Measure |
Betamethasone Valerate (0.1%) Cream
n=37 Participants
All sites (left or right) treated with Betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment
n=37 Participants
All sites (left or right) treated with Crisaborole (2%) ointment.
|
Betamethasone Valerate (0.1%) Cream Without FLG Mutation
All participants without a FLG mutation who treated with betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment Without FLG Mutation
All participants without a FLG mutation who treated with crisaborole (2%) ointment.
|
|---|---|---|---|---|
|
Change in Visual Redness/Erythema During and After 28 Days Treatment
Day 1 · 0
|
24 Participants
|
22 Participants
|
—
|
—
|
|
Change in Visual Redness/Erythema During and After 28 Days Treatment
Day 1 · 0.5
|
13 Participants
|
15 Participants
|
—
|
—
|
|
Change in Visual Redness/Erythema During and After 28 Days Treatment
Day 1 · 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change in Visual Redness/Erythema During and After 28 Days Treatment
Day 15 · 0
|
26 Participants
|
24 Participants
|
—
|
—
|
|
Change in Visual Redness/Erythema During and After 28 Days Treatment
Day 15 · 0.5
|
9 Participants
|
11 Participants
|
—
|
—
|
|
Change in Visual Redness/Erythema During and After 28 Days Treatment
Day 15 · 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change in Visual Redness/Erythema During and After 28 Days Treatment
Day 29 · 0
|
18 Participants
|
21 Participants
|
—
|
—
|
|
Change in Visual Redness/Erythema During and After 28 Days Treatment
Day 29 · 0.5
|
11 Participants
|
9 Participants
|
—
|
—
|
|
Change in Visual Redness/Erythema During and After 28 Days Treatment
Day 29 · 1
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Change in Visual Redness/Erythema During and After 28 Days Treatment
Day 57 · 0
|
16 Participants
|
20 Participants
|
—
|
—
|
|
Change in Visual Redness/Erythema During and After 28 Days Treatment
Day 57 · 0.5
|
15 Participants
|
11 Participants
|
—
|
—
|
|
Change in Visual Redness/Erythema During and After 28 Days Treatment
Day 57 · 1
|
1 Participants
|
1 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, Day 15, Day 29 and Day 57Population: Full Analysis Set
The difference in the change in superficial plexus depth (μm) measured by angiographic OCT.
Outcome measures
| Measure |
Betamethasone Valerate (0.1%) Cream
n=35 Participants
All sites (left or right) treated with Betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment
n=35 Participants
All sites (left or right) treated with Crisaborole (2%) ointment.
|
Betamethasone Valerate (0.1%) Cream Without FLG Mutation
All participants without a FLG mutation who treated with betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment Without FLG Mutation
All participants without a FLG mutation who treated with crisaborole (2%) ointment.
|
|---|---|---|---|---|
|
Superficial Plexus Depth
Day 1 to Day 29
|
-20.3 µm
Standard Deviation 17.44
|
-9.5 µm
Standard Deviation 20.76
|
—
|
—
|
|
Superficial Plexus Depth
Day 29 to Day 57
|
13.4 µm
Standard Deviation 20.60
|
7.3 µm
Standard Deviation 17.25
|
—
|
—
|
|
Superficial Plexus Depth
Day 1 to Day 15
|
-22.3 µm
Standard Deviation 16.42
|
-13.1 µm
Standard Deviation 19.11
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, Day 15, Day 29 and Day 57.Population: Full Analysis Set
The difference in the mean blood vessel diameter (μm) measured by angiographic OCT.
Outcome measures
| Measure |
Betamethasone Valerate (0.1%) Cream
n=35 Participants
All sites (left or right) treated with Betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment
n=35 Participants
All sites (left or right) treated with Crisaborole (2%) ointment.
|
Betamethasone Valerate (0.1%) Cream Without FLG Mutation
All participants without a FLG mutation who treated with betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment Without FLG Mutation
All participants without a FLG mutation who treated with crisaborole (2%) ointment.
|
|---|---|---|---|---|
|
Blood Vessel Diameter
Day 1 to Day 29
|
-1.02 µm
Standard Deviation 4.432
|
-1.04 µm
Standard Deviation 4.518
|
—
|
—
|
|
Blood Vessel Diameter
Day 1 to Day 15
|
-0.37 µm
Standard Deviation 4.195
|
-0.69 µm
Standard Deviation 3.964
|
—
|
—
|
|
Blood Vessel Diameter
Day 29 to Day 57
|
1.36 µm
Standard Deviation 3.320
|
0.13 µm
Standard Deviation 3.393
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, Day 15, Day 29 and Day 57.Population: Full Analysis Set
The difference in the change in blood vessel density (segments/mm²) measured by angiographic OCT. Angiographic OCT images taken on Day 1, Day 15, Day 29 and Day 57.
Outcome measures
| Measure |
Betamethasone Valerate (0.1%) Cream
n=35 Participants
All sites (left or right) treated with Betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment
n=35 Participants
All sites (left or right) treated with Crisaborole (2%) ointment.
|
Betamethasone Valerate (0.1%) Cream Without FLG Mutation
All participants without a FLG mutation who treated with betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment Without FLG Mutation
All participants without a FLG mutation who treated with crisaborole (2%) ointment.
|
|---|---|---|---|---|
|
Blood Vessel Density
Day 1 to Day 29
|
-1.27 segments/mm²
Standard Deviation 18.381
|
3.37 segments/mm²
Standard Deviation 15.842
|
—
|
—
|
|
Blood Vessel Density
Day 1 to Day 15
|
-1.12 segments/mm²
Standard Deviation 17.769
|
-0.56 segments/mm²
Standard Deviation 16.825
|
—
|
—
|
|
Blood Vessel Density
Day 29 to Day 57
|
4.79 segments/mm²
Standard Deviation 17.677
|
-0.15 segments/mm²
Standard Deviation 17.630
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 and Day 29.Population: Full Analysis Set
The difference in the change in collagen matrix index measured by polarisation sensitive (PS-)OCT. This metric relates to the arrangement and density of collagen fibres within the skin and is informed by birefringence data. Inhibition of collagen synthesis is an adverse effect associated with epidermal atrophy that occurs following long-term use of topical corticosteroids. There is no range for this measurement. The higher the level of change, the more damage has been done to the epidermis.
Outcome measures
| Measure |
Betamethasone Valerate (0.1%) Cream
n=32 Participants
All sites (left or right) treated with Betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment
n=32 Participants
All sites (left or right) treated with Crisaborole (2%) ointment.
|
Betamethasone Valerate (0.1%) Cream Without FLG Mutation
All participants without a FLG mutation who treated with betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment Without FLG Mutation
All participants without a FLG mutation who treated with crisaborole (2%) ointment.
|
|---|---|---|---|---|
|
Collagen Matrix Index
|
100.0 AU
Standard Deviation 102.11
|
-4.0 AU
Standard Deviation 78.55
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, Day 15, Day 29 and Day 57.Population: Full Analysis Set
The difference in the change in carboxylate 1 levels (indirect measure of NMF levels, not to be confused with direct quantification from stratum corneum samples by HPLC) in the stratum corneum measured by FTIR spectroscopy. FTIR spectra of the skin surface taken on Day 1, Day 15, Day 29 and Day 57. Carboxylate 1 is a component of Natural Moisturising Factors and relates to how well the skin retains water. There is no range for this measurement. The greater the value, the less able the skin is to hold onto water.
Outcome measures
| Measure |
Betamethasone Valerate (0.1%) Cream
n=35 Participants
All sites (left or right) treated with Betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment
n=35 Participants
All sites (left or right) treated with Crisaborole (2%) ointment.
|
Betamethasone Valerate (0.1%) Cream Without FLG Mutation
All participants without a FLG mutation who treated with betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment Without FLG Mutation
All participants without a FLG mutation who treated with crisaborole (2%) ointment.
|
|---|---|---|---|---|
|
Carboxylate 1 Levels
Day 1 to Day 29
|
-6.75 absorbance units
Standard Deviation 5.800
|
-4.88 absorbance units
Standard Deviation 5.450
|
—
|
—
|
|
Carboxylate 1 Levels
Day 1 to Day 15
|
-3.1 absorbance units
Standard Deviation 4.887
|
-3.52 absorbance units
Standard Deviation 4.675
|
—
|
—
|
|
Carboxylate 1 Levels
Day 29 to Day 57
|
6.97 absorbance units
Standard Deviation 4.594
|
4.88 absorbance units
Standard Deviation 4.686
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, Day 15, Day 29 and Day 57.Population: Full Analysis Set
The difference in the change in carboxylate 2 levels (indirect measure of NMF levels, not to be confused with direct quantification from stratum corneum samples by HPLC) in the stratum corneum measured by FTIR spectroscopy. FTIR spectra of the skin surface taken on Day 1, Day 15, Day 29 and Day 57. Carboxylate 2 is a component of Natural Moisturising Factors and relates to how well the skin retains water. There is no range for this measurement. The greater the value, the less able the skin is to hold onto water.
Outcome measures
| Measure |
Betamethasone Valerate (0.1%) Cream
n=35 Participants
All sites (left or right) treated with Betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment
n=35 Participants
All sites (left or right) treated with Crisaborole (2%) ointment.
|
Betamethasone Valerate (0.1%) Cream Without FLG Mutation
All participants without a FLG mutation who treated with betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment Without FLG Mutation
All participants without a FLG mutation who treated with crisaborole (2%) ointment.
|
|---|---|---|---|---|
|
Carboxylate 2 Levels
Day 1 to Day 29
|
-2.45 absorbance units
Standard Deviation 4.989
|
1.31 absorbance units
Standard Deviation 10.269
|
—
|
—
|
|
Carboxylate 2 Levels
Day 1 to Day 15
|
-0.07 absorbance units
Standard Deviation 4.779
|
2.55 absorbance units
Standard Deviation 8.839
|
—
|
—
|
|
Carboxylate 2 Levels
Day 29 to Day 57
|
3.75 absorbance units
Standard Deviation 7.672
|
-0.58 absorbance units
Standard Deviation 10.127
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 29Population: Full Analysis Set
The difference in stratum corneum lipid structure measured by FTIR spectroscopy in conjunction with tape-stripping. FTIR spectra taken through the stratum corneum during tape-stripping on Day 29. Lipid chain structure was assessed by quantifying the mean frequency of the lipid peak at 2850 cm-1 (corresponding to the CH2 group of lipids). There is no range for this measurement. The higher the absorbance, the less ordered the lipid packing and weaker the structural integrity of the skin.
Outcome measures
| Measure |
Betamethasone Valerate (0.1%) Cream
n=32 Participants
All sites (left or right) treated with Betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment
n=32 Participants
All sites (left or right) treated with Crisaborole (2%) ointment.
|
Betamethasone Valerate (0.1%) Cream Without FLG Mutation
All participants without a FLG mutation who treated with betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment Without FLG Mutation
All participants without a FLG mutation who treated with crisaborole (2%) ointment.
|
|---|---|---|---|---|
|
Stratum Corneum Lipid Structure
|
2849.739 absorbance units
Standard Deviation 0.4140
|
2849.681 absorbance units
Standard Deviation 0.4475
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Saliva samples at Day 1Population: Full Analysis Set
Number of FLG loss-of-function mutation carriers
Outcome measures
| Measure |
Betamethasone Valerate (0.1%) Cream
n=37 Participants
All sites (left or right) treated with Betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment
All sites (left or right) treated with Crisaborole (2%) ointment.
|
Betamethasone Valerate (0.1%) Cream Without FLG Mutation
All participants without a FLG mutation who treated with betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment Without FLG Mutation
All participants without a FLG mutation who treated with crisaborole (2%) ointment.
|
|---|---|---|---|---|
|
FLG Mutation Carriers
wt/wt
|
24 Participants
|
—
|
—
|
—
|
|
FLG Mutation Carriers
wt/flg
|
9 Participants
|
—
|
—
|
—
|
|
FLG Mutation Carriers
wt/unknown
|
4 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, Day 15, Day 29 and Day 57Population: Full Analysis Set
Descriptive tabulations of TEWL by mutation status.
Outcome measures
| Measure |
Betamethasone Valerate (0.1%) Cream
n=9 Participants
All sites (left or right) treated with Betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment
n=9 Participants
All sites (left or right) treated with Crisaborole (2%) ointment.
|
Betamethasone Valerate (0.1%) Cream Without FLG Mutation
n=24 Participants
All participants without a FLG mutation who treated with betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment Without FLG Mutation
n=24 Participants
All participants without a FLG mutation who treated with crisaborole (2%) ointment.
|
|---|---|---|---|---|
|
Descriptive Tabulations of TEWL by Mutation Status
Day 1
|
13.7 g/m²/h
Standard Deviation 5.08
|
14.1 g/m²/h
Standard Deviation 5.94
|
13.0 g/m²/h
Standard Deviation 3.77
|
13.0 g/m²/h
Standard Deviation 4.20
|
|
Descriptive Tabulations of TEWL by Mutation Status
Day 15
|
12.7 g/m²/h
Standard Deviation 2.86
|
15.5 g/m²/h
Standard Deviation 5.27
|
12.3 g/m²/h
Standard Deviation 2.66
|
15.0 g/m²/h
Standard Deviation 3.33
|
|
Descriptive Tabulations of TEWL by Mutation Status
Day 29
|
11.8 g/m²/h
Standard Deviation 2.42
|
14.2 g/m²/h
Standard Deviation 5.07
|
12.5 g/m²/h
Standard Deviation 3.44
|
14.65 g/m²/h
Standard Deviation 3.48
|
|
Descriptive Tabulations of TEWL by Mutation Status
Day 57
|
13.8 g/m²/h
Standard Deviation 3.90
|
15.2 g/m²/h
Standard Deviation 4.76
|
14.9 g/m²/h
Standard Deviation 4.26
|
15.3 g/m²/h
Standard Deviation 6.33
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, Day 15, Day 29 and Day 57.Population: Full Analysis Set
Descriptive tabulations of epidermal thickness (structural OCT derived) by mutation status.
Outcome measures
| Measure |
Betamethasone Valerate (0.1%) Cream
n=9 Participants
All sites (left or right) treated with Betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment
n=9 Participants
All sites (left or right) treated with Crisaborole (2%) ointment.
|
Betamethasone Valerate (0.1%) Cream Without FLG Mutation
n=24 Participants
All participants without a FLG mutation who treated with betamethasone valerate (0.1%) cream.
|
Crisaborole (2%) Ointment Without FLG Mutation
n=24 Participants
All participants without a FLG mutation who treated with crisaborole (2%) ointment.
|
|---|---|---|---|---|
|
Epidermal Thickness by Mutation Status
Day 57
|
91.0 µm
Standard Deviation 14.47
|
100.1 µm
Standard Deviation 17.10
|
91.6 µm
Standard Deviation 9.92
|
96.0 µm
Standard Deviation 11.24
|
|
Epidermal Thickness by Mutation Status
Day 1
|
101.6 µm
Standard Deviation 20.75
|
100.9 µm
Standard Deviation 17.94
|
99.4 µm
Standard Deviation 13.92
|
100.8 µm
Standard Deviation 18.39
|
|
Epidermal Thickness by Mutation Status
Day 15
|
68.9 µm
Standard Deviation 11.02
|
83.5 µm
Standard Deviation 137.71
|
71.7 µm
Standard Deviation 11.25
|
86.8 µm
Standard Deviation 12.46
|
|
Epidermal Thickness by Mutation Status
Day 29
|
64.4 µm
Standard Deviation 12.42
|
78.5 µm
Standard Deviation 17.96
|
67.7 µm
Standard Deviation 11.68
|
87.7 µm
Standard Deviation 12.94
|
Adverse Events
Betamethasone Valerate (0.1%) Cream
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Crisaborole (2%) Ointment
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Systemic Adverse Events
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Betamethasone Valerate (0.1%) Cream
n=37 participants at risk
Adverse events that can be attributed to betamethasone valerate (0.1% cream
|
Crisaborole (2%) Ointment
n=37 participants at risk
Adverse events that can be attributed to crisaborole (2%) ointment
|
Systemic Adverse Events
n=37 participants at risk
Adverse events that cannot be attributed to either intervention
|
|---|---|---|---|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
Other adverse events
| Measure |
Betamethasone Valerate (0.1%) Cream
n=37 participants at risk
Adverse events that can be attributed to betamethasone valerate (0.1% cream
|
Crisaborole (2%) Ointment
n=37 participants at risk
Adverse events that can be attributed to crisaborole (2%) ointment
|
Systemic Adverse Events
n=37 participants at risk
Adverse events that cannot be attributed to either intervention
|
|---|---|---|---|
|
General disorders
Application site papules
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Nervous system disorders
Headache
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
43.2%
16/37 • Number of events 16 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Infections and infestations
Candida infection
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Skin and subcutaneous tissue disorders
Papule
|
2.7%
1/37 • Number of events 3 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
5.4%
2/37 • Number of events 3 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 3 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 2 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Nervous system disorders
Migraine
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
General disorders
Pyrexia
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.4%
2/37 • Number of events 5 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 5 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
5.4%
2/37 • Number of events 5 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
General disorders
Fatigue
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
5.4%
2/37 • Number of events 2 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.7%
1/37 • Number of events 3 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
5.4%
2/37 • Number of events 3 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
General disorders
Application site reaction
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract infection
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Gastrointestinal disorders
Upper abdominal pain
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Infections and infestations
COVID-19 infection
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
General disorders
Chills
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
General disorders
Application site pruritis
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
General disorders
Application site bruise
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Infections and infestations
Infection
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Nervous system disorders
Dizziness
|
2.7%
1/37 • Number of events 2 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 2 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 2 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
General disorders
Hernia
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
5.4%
2/37 • Number of events 2 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
General disorders
Application site rash
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
General disorders
Pain
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
0.00%
0/37 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
2.7%
1/37 • Number of events 1 • Incidences of adverse events were collected from the date of the first participant's enrolment (10/12/2020) until the date the last participant completed (24/09/2021). Adverse event data was collected over a period of 9 months.
The definition of AE for SMART is: "Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product." The definition of SAE is expanded to include a point that any complications that occur during hospitalisation are to be documented as AEs. If a complication prolongs hospitalisation, this is an SAE. Elective treatment is not an AE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place