Trial Outcomes & Findings for Topical Sirolimus Ointment for Cutaneous Angiofibromas in Subjects With Tuberous Sclerosis Complex (NCT NCT03363763)
NCT ID: NCT03363763
Last Updated: 2025-12-01
Results Overview
The Investigator's Global Assessment (IGA) was recorded on a 5-point scale, 0 (minimum) to 5 (maximum) \[0 = Clear skin with no signs of erythema and no disease related lesions, 1 = Slight redness with few disease related lesions, 2 = Greater than Grade 1; definite redness with scattered, some disease related lesions, 3 = Greater than Grade 2; marked redness, concentrated, many disease related lesions, 4 = Greater than Grade 3; very bright redness, confluent, highly concentrated disease related lesions, 5= Greater than Grade 4; fiery redness, very extensive disease related lesions covering very large area of the face\]. A higher score indicates a more severe, worse outcome.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Double-blind phase and Open-label phase Weeks 4 and 12
Results posted on
2025-12-01
Participant Flow
Study subjects were enrolled at 3-5 investigational sites in the United States.
At the time of study closure, a total of 28 participants were screened and 24 were randomized and received treatment. This study was early terminated due to another company receiving exclusivity.
Participant milestones
| Measure |
Sirolimus 0.2%
Sirolimus 0.2% ointment applied topically once daily at bedtime for 12 weeks
|
Sirolimus 0.4%
Sirolimus 0.4% ointment applied topically once daily at bedtime for 12 weeks
|
Placebo
Placebo ointment applied topically once daily at bedtime for 12 weeks
|
|---|---|---|---|
|
Double-Blind Phase
STARTED
|
7
|
8
|
9
|
|
Double-Blind Phase
COMPLETED
|
7
|
8
|
9
|
|
Double-Blind Phase
NOT COMPLETED
|
0
|
0
|
0
|
|
Open-label Phase
STARTED
|
7
|
8
|
9
|
|
Open-label Phase
COMPLETED
|
6
|
6
|
7
|
|
Open-label Phase
NOT COMPLETED
|
1
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topical Sirolimus Ointment for Cutaneous Angiofibromas in Subjects With Tuberous Sclerosis Complex
Baseline characteristics by cohort
| Measure |
Arm 1
n=7 Participants
Sirolimus 0.2% ointment applied topically once daily at bedtime for 12 weeks
|
Arm 2
n=8 Participants
Sirolimus 0.4% ointment applied topically once daily at bedtime for 12 weeks
|
Arm 3
n=9 Participants
Placebo ointment applied topically once daily at bedtime for 12 weeks
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
12.1 Years
STANDARD_DEVIATION 2.73 • n=121 Participants
|
13.1 Years
STANDARD_DEVIATION 4.67 • n=122 Participants
|
10.9 Years
STANDARD_DEVIATION 3.44 • n=243 Participants
|
12.0 Years
STANDARD_DEVIATION 3.69 • n=24 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=121 Participants
|
6 Participants
n=122 Participants
|
7 Participants
n=243 Participants
|
17 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=121 Participants
|
2 Participants
n=122 Participants
|
2 Participants
n=243 Participants
|
7 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=121 Participants
|
2 Participants
n=122 Participants
|
2 Participants
n=243 Participants
|
5 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=121 Participants
|
6 Participants
n=122 Participants
|
7 Participants
n=243 Participants
|
19 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=121 Participants
|
3 Participants
n=122 Participants
|
2 Participants
n=243 Participants
|
7 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=121 Participants
|
5 Participants
n=122 Participants
|
6 Participants
n=243 Participants
|
16 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
1 Participants
n=24 Participants
|
|
Height (cm)
|
154.8 cm
STANDARD_DEVIATION 11.65 • n=121 Participants
|
144.9 cm
STANDARD_DEVIATION 23.04 • n=122 Participants
|
141.2 cm
STANDARD_DEVIATION 16.39 • n=243 Participants
|
146.6 cm
STANDARD_DEVIATION 18.02 • n=24 Participants
|
|
Weight (kg)
|
50.3 kg
STANDARD_DEVIATION 20.08 • n=121 Participants
|
41.3 kg
STANDARD_DEVIATION 18.20 • n=122 Participants
|
37.0 kg
STANDARD_DEVIATION 9.37 • n=243 Participants
|
42.3 kg
STANDARD_DEVIATION 16.35 • n=24 Participants
|
|
BMI (kg/m^2)
|
20.6 kg/m^2
STANDARD_DEVIATION 6.52 • n=121 Participants
|
18.7 kg/m^2
STANDARD_DEVIATION 3.92 • n=122 Participants
|
18.7 kg/m^2
STANDARD_DEVIATION 2.85 • n=243 Participants
|
19.2 kg/m^2
STANDARD_DEVIATION 4.46 • n=24 Participants
|
PRIMARY outcome
Timeframe: Double-blind phase and Open-label phase Weeks 4 and 12Population: In the double-blind phase all randomized participants received study treatment and completed week 12 Investigator Global Assessment (IGA). In open-label phase, total of 19 participants completed week 24 (Open-label week 12) Investigator Global Assessment (IGA).
The Investigator's Global Assessment (IGA) was recorded on a 5-point scale, 0 (minimum) to 5 (maximum) \[0 = Clear skin with no signs of erythema and no disease related lesions, 1 = Slight redness with few disease related lesions, 2 = Greater than Grade 1; definite redness with scattered, some disease related lesions, 3 = Greater than Grade 2; marked redness, concentrated, many disease related lesions, 4 = Greater than Grade 3; very bright redness, confluent, highly concentrated disease related lesions, 5= Greater than Grade 4; fiery redness, very extensive disease related lesions covering very large area of the face\]. A higher score indicates a more severe, worse outcome.
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo ointment applied topically once daily at bedtime for 12 weeks
|
Sirolimus 0.2%
n=7 Participants
Sirolimus 0.2% ointment applied topically once daily at bedtime for 12 weeks
|
Sirolimus 0.4%
n=8 Participants
Sirolimus 0.4% ointment applied topically once daily at bedtime for 12 weeks
|
|---|---|---|---|
|
The Percentage of Participants Achieved at Least 2-grade Improvement
Primary Endpoint (>=2 point improvement) Week 12 · No (N)
|
9 Participants
|
6 Participants
|
6 Participants
|
|
The Percentage of Participants Achieved at Least 2-grade Improvement
Primary Endpoint (>=2 point improvement) Week 12 · Yes (Y)
|
0 Participants
|
1 Participants
|
2 Participants
|
|
The Percentage of Participants Achieved at Least 2-grade Improvement
Primary Endpoint (>=2 point improvement) Week 4 · No (N)
|
9 Participants
|
6 Participants
|
8 Participants
|
|
The Percentage of Participants Achieved at Least 2-grade Improvement
Primary Endpoint (>=2 point improvement) Week 4 · Yes (Y)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
The Percentage of Participants Achieved at Least 2-grade Improvement
Primary Endpoint (>/=2 point improvement) (Open-label Week 4) · No (N)
|
7 Participants
|
6 Participants
|
5 Participants
|
|
The Percentage of Participants Achieved at Least 2-grade Improvement
Primary Endpoint (>/=2 point improvement) (Open-label Week 4) · Yes (Y)
|
2 Participants
|
1 Participants
|
1 Participants
|
|
The Percentage of Participants Achieved at Least 2-grade Improvement
Primary Endpoint (>=2 point improvement) (Open-label Week 12) · No (N)
|
3 Participants
|
4 Participants
|
5 Participants
|
|
The Percentage of Participants Achieved at Least 2-grade Improvement
Primary Endpoint (>=2 point improvement) (Open-label Week 12) · Yes (Y)
|
4 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Double-blind phase and Open-label phase Weeks 4 and 12Population: In the double-blind phase, all randomized participants received study treatment and completed week 12 Investigator Global Assessment (IGA). In open-label phase, total of 19 participants completed week 24 (Open-label week 12) Investigator Global Assessment (IGA).
The Investigator's Global Assessment (IGA) was recorded on a 5-point scale, 0 (minimum) to 5 (maximum) \[0 = Clear skin with no signs of erythema and no disease related lesions, 1 = Slight redness with few disease related lesions, 2 = Greater than Grade 1; definite redness with scattered, some disease related lesions, 3 = Greater than Grade 2; marked redness, concentrated, many disease related lesions, 4 = Greater than Grade 3; very bright redness, confluent, highly concentrated disease related lesions, 5= Greater than Grade 4; fiery redness, very extensive disease related lesions covering very large area of the face\]. A higher score indicates a more severe, worse outcome. Negative values indicate improvement (0 = no change, -1 = 1-point improvement, -2 = 2-point improvement)
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo ointment applied topically once daily at bedtime for 12 weeks
|
Sirolimus 0.2%
n=7 Participants
Sirolimus 0.2% ointment applied topically once daily at bedtime for 12 weeks
|
Sirolimus 0.4%
n=8 Participants
Sirolimus 0.4% ointment applied topically once daily at bedtime for 12 weeks
|
|---|---|---|---|
|
The Change in Baseline in Investigator's Global Assessment (IGA) by Visit
Change from Baseline in IGA by Visit: Week 4 · 0 = No change from baseline
|
8 Participants
|
2 Participants
|
4 Participants
|
|
The Change in Baseline in Investigator's Global Assessment (IGA) by Visit
Change from Baseline in IGA by Visit: Week 4 · -1 = 1- point improvement from baseline
|
1 Participants
|
4 Participants
|
4 Participants
|
|
The Change in Baseline in Investigator's Global Assessment (IGA) by Visit
Change from Baseline in IGA by Visit: Week 4 · -2 = 2-point improvement from baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
The Change in Baseline in Investigator's Global Assessment (IGA) by Visit
Change from Baseline in IGA by Visit: Week 4 · -3 = 3-point improvement from baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Change in Baseline in Investigator's Global Assessment (IGA) by Visit
Change from Baseline in IGA by Visit: Week 12 · 0 = No change from baseline
|
8 Participants
|
1 Participants
|
3 Participants
|
|
The Change in Baseline in Investigator's Global Assessment (IGA) by Visit
Change from Baseline in IGA by Visit: Week 12 · -1 = 1- point improvement from baseline
|
1 Participants
|
5 Participants
|
3 Participants
|
|
The Change in Baseline in Investigator's Global Assessment (IGA) by Visit
Change from Baseline in IGA by Visit: Week 12 · -2 = 2-point improvement from baseline
|
0 Participants
|
1 Participants
|
2 Participants
|
|
The Change in Baseline in Investigator's Global Assessment (IGA) by Visit
Change from Baseline in IGA by Visit: Week 12 · -3 = 3-point improvement from baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Change in Baseline in Investigator's Global Assessment (IGA) by Visit
Change from Baseline in IGA by Visit: Open-label week 4 · 0 = No change from baseline
|
1 Participants
|
1 Participants
|
2 Participants
|
|
The Change in Baseline in Investigator's Global Assessment (IGA) by Visit
Change from Baseline in IGA by Visit: Open-label week 4 · -1 = 1- point improvement from baseline
|
6 Participants
|
5 Participants
|
3 Participants
|
|
The Change in Baseline in Investigator's Global Assessment (IGA) by Visit
Change from Baseline in IGA by Visit: Open-label week 4 · -2 = 2-point improvement from baseline
|
2 Participants
|
1 Participants
|
1 Participants
|
|
The Change in Baseline in Investigator's Global Assessment (IGA) by Visit
Change from Baseline in IGA by Visit: Open-label week 4 · -3 = 3-point improvement from baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Change in Baseline in Investigator's Global Assessment (IGA) by Visit
Change from Baseline in IGA by visit: Open-label week 12 · 0 = No change from baseline
|
0 Participants
|
0 Participants
|
2 Participants
|
|
The Change in Baseline in Investigator's Global Assessment (IGA) by Visit
Change from Baseline in IGA by visit: Open-label week 12 · -1 = 1- point improvement from baseline
|
3 Participants
|
4 Participants
|
3 Participants
|
|
The Change in Baseline in Investigator's Global Assessment (IGA) by Visit
Change from Baseline in IGA by visit: Open-label week 12 · -2 = 2-point improvement from baseline
|
3 Participants
|
1 Participants
|
1 Participants
|
|
The Change in Baseline in Investigator's Global Assessment (IGA) by Visit
Change from Baseline in IGA by visit: Open-label week 12 · -3 = 3-point improvement from baseline
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Double-blind phase Weeks 4 and 12 and Open-label phase Week 12Population: \[Not specified\]
The Facial Angiofibromas Severity Index (FASI) is derived from the measurements of erythema, average size, and lesion extension. The FASI score is the sum of scores of Erythema, Size, and Extension. Erythema was recorded on a 4-point grade scale from 0 (minimum) to 4 (maximum) \[0 = clear skin with no signs of erythema, 1 = almost clear; slight redness, 3= moderate erythema; marked redness, 4= severe erythema; very bright redness\]. Size was recorded on a 4-point grade scale from 0 (minimum) to 4 (maximum) \[0 = no lesions, 1= few lesions, average size \</= 2mm, 2 = scattered, some lesions, average lesion size \>2-to \</= 5 mm, 3 = concentrated, many lesions, average lesion size \> 5mmg to \</= 10mm, 4 = confluent, highly concentrated lesions\]. Extension was recorded on a grade scale of 0 (minimum), 2, and 3 (maximum) \[0 = no lesions, 2 = \</= 50% of the cheek surface, 3 = \>50% of the cheek surface\]. A higher score for Erythema, Size, and Extension means a more severe, worse outcome.
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo ointment applied topically once daily at bedtime for 12 weeks
|
Sirolimus 0.2%
n=7 Participants
Sirolimus 0.2% ointment applied topically once daily at bedtime for 12 weeks
|
Sirolimus 0.4%
n=8 Participants
Sirolimus 0.4% ointment applied topically once daily at bedtime for 12 weeks
|
|---|---|---|---|
|
The Percentage of Subjects With at Least 30% Improvement in the Facial Angiofibromas Severity Index (FASI) Score.
>=30% Improvement in FASI Score Week 4 · No (N)
|
9 Participants
|
5 Participants
|
6 Participants
|
|
The Percentage of Subjects With at Least 30% Improvement in the Facial Angiofibromas Severity Index (FASI) Score.
>=30% Improvement in FASI Score Week 4 · Yes (Y)
|
0 Participants
|
2 Participants
|
2 Participants
|
|
The Percentage of Subjects With at Least 30% Improvement in the Facial Angiofibromas Severity Index (FASI) Score.
>=30% Improvement in FASI Score Week 12 · No (N)
|
9 Participants
|
5 Participants
|
5 Participants
|
|
The Percentage of Subjects With at Least 30% Improvement in the Facial Angiofibromas Severity Index (FASI) Score.
>=30% Improvement in FASI Score Week 12 · Yes (Y)
|
0 Participants
|
2 Participants
|
3 Participants
|
|
The Percentage of Subjects With at Least 30% Improvement in the Facial Angiofibromas Severity Index (FASI) Score.
>= 30% Improvement in FASI Score: Open-label week 12 · No (N)
|
3 Participants
|
3 Participants
|
5 Participants
|
|
The Percentage of Subjects With at Least 30% Improvement in the Facial Angiofibromas Severity Index (FASI) Score.
>= 30% Improvement in FASI Score: Open-label week 12 · Yes (Y)
|
3 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Double blind phase weeks 4 and 12 and Open-label week 12Population: \[Not specified\]
The Facial Angiofibromas Severity Index (FASI) is derived from the measurements of erythema, average size, and lesion extension. The FASI score is the sum of scores of Erythema, Size, and Extension. Erythema was recorded on a 4-point grade scale from 0 (minimum) to 4 (maximum) \[0 = clear skin with no signs of erythema, 1 = almost clear; slight redness, 3= moderate erythema; marked redness, 4= severe erythema; very bright redness\]. Size was recorded on a 4-point grade scale from 0 (minimum) to 4 (maximum) \[0 = no lesions, 1= few lesions, average size \</= 2mm, 2 = scattered, some lesions, average lesion size \>2-to \</= 5 mm, 3 = concentrated, many lesions, average lesion size \> 5mmg to \</= 10mm, 4 = confluent, highly concentrated lesions\]. Extension was recorded on a grade scale of 0 (minimum), 2, and 3 (maximum) \[0 = no lesions, 2 = \</= 50% of the cheek surface, 3 = \>50% of the cheek surface\]. A higher score for Erythema, Size, and Extension means a more severe, worse outcome.
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo ointment applied topically once daily at bedtime for 12 weeks
|
Sirolimus 0.2%
n=7 Participants
Sirolimus 0.2% ointment applied topically once daily at bedtime for 12 weeks
|
Sirolimus 0.4%
n=8 Participants
Sirolimus 0.4% ointment applied topically once daily at bedtime for 12 weeks
|
|---|---|---|---|
|
Facial Angifibromas Severity Index (FASI) Score
Baseline FASI Total Score
|
7.89 score on a scale
Standard Deviation 1.27
|
6.86 score on a scale
Standard Deviation 1.35
|
7.38 score on a scale
Standard Deviation 1.19
|
|
Facial Angifibromas Severity Index (FASI) Score
Week 4 FASI Total Score
|
7.33 score on a scale
Standard Deviation 1.32
|
5.71 score on a scale
Standard Deviation 1.25
|
6.5 score on a scale
Standard Deviation 1.69
|
|
Facial Angifibromas Severity Index (FASI) Score
Week 12 FASI Total Score
|
7 score on a scale
Standard Deviation 1.58
|
5.57 score on a scale
Standard Deviation 0.98
|
5.75 score on a scale
Standard Deviation 1.39
|
|
Facial Angifibromas Severity Index (FASI) Score
Open-label week 12 FASI Total Score
|
5.33 score on a scale
Standard Deviation 1.51
|
5 score on a scale
Standard Deviation 1
|
6 score on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Double blind phase Weeks 4 and 12 and Open-label phase Week 12Population: \[Not specified\]
Lesion counts are measured based on categories 0 to 4 \[0 = no lesion, 1 = \<25 lesions, 2 = 25 to 50 lesions, 3 = 51 to 75 lesions, 4 = \> 75 lesions\]
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo ointment applied topically once daily at bedtime for 12 weeks
|
Sirolimus 0.2%
n=7 Participants
Sirolimus 0.2% ointment applied topically once daily at bedtime for 12 weeks
|
Sirolimus 0.4%
n=8 Participants
Sirolimus 0.4% ointment applied topically once daily at bedtime for 12 weeks
|
|---|---|---|---|
|
The Percentage of Subjects Achieved at Least 2-grade Improvement in Categorical Lesion Counts by Visit
>=2 grade improvement in lesion: Week 4 · Yes (N)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
The Percentage of Subjects Achieved at Least 2-grade Improvement in Categorical Lesion Counts by Visit
>=2 grade improvement in lesion: Week 12 · No (N)
|
9 Participants
|
6 Participants
|
7 Participants
|
|
The Percentage of Subjects Achieved at Least 2-grade Improvement in Categorical Lesion Counts by Visit
>=2 grade improvement in lesion: Week 12 · Yes (N)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
The Percentage of Subjects Achieved at Least 2-grade Improvement in Categorical Lesion Counts by Visit
>=2 grade improvement in lesion: Open-label week 12 · No (N)
|
4 Participants
|
4 Participants
|
5 Participants
|
|
The Percentage of Subjects Achieved at Least 2-grade Improvement in Categorical Lesion Counts by Visit
>=2 grade improvement in lesion: Open-label week 12 · Yes (N)
|
2 Participants
|
1 Participants
|
1 Participants
|
|
The Percentage of Subjects Achieved at Least 2-grade Improvement in Categorical Lesion Counts by Visit
>=2 grade improvement in lesion: Week 4 · No (N)
|
9 Participants
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Double blind phase weeks 4 and 12 and open-label phase week 12Population: \[Not Specified\]
Lesion counts are measured based on categories 0 to 4 (0 = no lesion, 1 = \<25 lesions, 2 = 25 to 50 lesions, 3 = 51 to 75 lesions, 4 = \> 75 lesions) Negative values indicate improvement (0 = no change, -1 = 1-point improvement, -2 = 2-point improvement)
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo ointment applied topically once daily at bedtime for 12 weeks
|
Sirolimus 0.2%
n=7 Participants
Sirolimus 0.2% ointment applied topically once daily at bedtime for 12 weeks
|
Sirolimus 0.4%
n=8 Participants
Sirolimus 0.4% ointment applied topically once daily at bedtime for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in Lesion Counts
Change from Baseline in lesion counts by visit: Week 4 · -2 = 2-point improvement from baseline
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Change From Baseline in Lesion Counts
Change from Baseline in lesion counts by visit: Week 4 · -3 = 3-point improvement from baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Lesion Counts
Change from Baseline in lesion counts by visit: Week 12 · 0 = No change from baseline
|
9 Participants
|
3 Participants
|
5 Participants
|
|
Change From Baseline in Lesion Counts
Change from Baseline in lesion counts by visit: Week 12 · -1 = 1-point improvement from baseline
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Change From Baseline in Lesion Counts
Change from Baseline in lesion counts by visit: Week 12 · -2 = 2-point improvement from baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change From Baseline in Lesion Counts
Change from Baseline in lesion counts by visit: Week 12 · -3 = 3-point improvement from baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change From Baseline in Lesion Counts
Change from baseline in lesion counts by visit: Open-label week 12 · 0 = No change from baseline
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Change From Baseline in Lesion Counts
Change from baseline in lesion counts by visit: Open-label week 12 · -1 = 1-point improvement from baseline
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Change From Baseline in Lesion Counts
Change from baseline in lesion counts by visit: Open-label week 12 · -2 = 2-point improvement from baseline
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Change From Baseline in Lesion Counts
Change from baseline in lesion counts by visit: Open-label week 12 · -3 = 3-point improvement from baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change From Baseline in Lesion Counts
Change from Baseline in lesion counts by visit: Week 4 · -1 = 1-point improvement from baseline
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Change From Baseline in Lesion Counts
Change from Baseline in lesion counts by visit: Week 4 · 0 = No change from baseline
|
8 Participants
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Double blind phase weeks 4 and 12 and open-label phase week 12Population: \[Not specified\]
The degree of lesion elevation is assessed on categories 0 to 4 (0 = no elevation over normal skin, 1 = possible but difficult to ascertain whether there is slight elevation above normal skin, 2 = slight but definite elevation, 3 = moderate elevation, 4 = marked elevation).
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo ointment applied topically once daily at bedtime for 12 weeks
|
Sirolimus 0.2%
n=7 Participants
Sirolimus 0.2% ointment applied topically once daily at bedtime for 12 weeks
|
Sirolimus 0.4%
n=8 Participants
Sirolimus 0.4% ointment applied topically once daily at bedtime for 12 weeks
|
|---|---|---|---|
|
The Percentage of Subjects Achieved at Least 2-grade Improvement in Lesion Elevation.
>=2 grade improvement in lesion elevation: Week 4 · No (N)
|
9 Participants
|
6 Participants
|
8 Participants
|
|
The Percentage of Subjects Achieved at Least 2-grade Improvement in Lesion Elevation.
>=2 grade improvement in lesion elevation: Week 4 · Yes (Y)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
The Percentage of Subjects Achieved at Least 2-grade Improvement in Lesion Elevation.
>=2 grade improvement in lesion elevation: Week 12 · Yes (Y)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
The Percentage of Subjects Achieved at Least 2-grade Improvement in Lesion Elevation.
>=2 grade improvement in lesion elevation: Open-label week 12 · No (N)
|
6 Participants
|
4 Participants
|
5 Participants
|
|
The Percentage of Subjects Achieved at Least 2-grade Improvement in Lesion Elevation.
>=2 grade improvement in lesion elevation: Open-label week 12 · Yes (Y)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
The Percentage of Subjects Achieved at Least 2-grade Improvement in Lesion Elevation.
>=2 grade improvement in lesion elevation: Week 12 · No (N)
|
9 Participants
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Double blind phase weeks 4 and 12 and open-label phase week 12Population: \[Not Specified\]
The degree of lesion elevation is assessed on categories 0 to 4 (0 = no elevation over normal skin, 1 = possible but difficult to ascertain whether there is slight elevation above normal skin, 2 = slight but definite elevation, 3 = moderate elevation, 4 = marked elevation) Negative values indicate improvement (0 = no change, -1 = 1-point improvement, -2 = 2-point improvement) One participant with baseline elevation grade of 1 improved to grade 0 at week 4. This participant is counted as improvement in lesion elevation. This participant was back to grade 1 at week 12 and open-label week 12.
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo ointment applied topically once daily at bedtime for 12 weeks
|
Sirolimus 0.2%
n=7 Participants
Sirolimus 0.2% ointment applied topically once daily at bedtime for 12 weeks
|
Sirolimus 0.4%
n=8 Participants
Sirolimus 0.4% ointment applied topically once daily at bedtime for 12 weeks
|
|---|---|---|---|
|
The Change From Baseline in Lesion Elevation
Change from Baseline in lesion elevation: Week 4 · 0 = No change from baseline
|
8 Participants
|
4 Participants
|
4 Participants
|
|
The Change From Baseline in Lesion Elevation
Change from Baseline in lesion elevation: Week 4 · -1 = 1-point improvement from baseline
|
1 Participants
|
2 Participants
|
4 Participants
|
|
The Change From Baseline in Lesion Elevation
Change from Baseline in lesion elevation: Week 4 · -2 = 2-point improvement from baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
The Change From Baseline in Lesion Elevation
Change from Baseline in lesion elevation: Week 12 · 0 = No change from baseline
|
9 Participants
|
3 Participants
|
4 Participants
|
|
The Change From Baseline in Lesion Elevation
Change from Baseline in lesion elevation: Week 12 · -1 = 1-point improvement from baseline
|
0 Participants
|
3 Participants
|
4 Participants
|
|
The Change From Baseline in Lesion Elevation
Change from Baseline in lesion elevation: Week 12 · -2 = 2-point improvement from baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
The Change From Baseline in Lesion Elevation
Change from baseline in lesion elevation: Open-label week 12 · 0 = No change from baseline
|
3 Participants
|
2 Participants
|
3 Participants
|
|
The Change From Baseline in Lesion Elevation
Change from baseline in lesion elevation: Open-label week 12 · -1 = 1-point improvement from baseline
|
3 Participants
|
2 Participants
|
2 Participants
|
|
The Change From Baseline in Lesion Elevation
Change from baseline in lesion elevation: Open-label week 12 · -2 = 2-point improvement from baseline
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Double blind phase weeks 4 and 12 and open-label phase weeks 4 and 12Population: \[Not specified\]
Subject self- assessment survey was based on categories 0 to 4 (0 = no redness and no disease related lesions, 1 = very mild redness with few very small bumps, 2 = mild redness with many small and medium sized bumps, 3 = moderate redness with many small and medium sized bumps, 4 = severe redness with numerous small, medium, and large sized bumps)
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo ointment applied topically once daily at bedtime for 12 weeks
|
Sirolimus 0.2%
n=7 Participants
Sirolimus 0.2% ointment applied topically once daily at bedtime for 12 weeks
|
Sirolimus 0.4%
n=8 Participants
Sirolimus 0.4% ointment applied topically once daily at bedtime for 12 weeks
|
|---|---|---|---|
|
The Percentage of Subjects Achieved at Least 2-grade Improvement in the Subject Self-assessment Survey
>=2 grade improvement in self-assessment: open-label week 12 · Yes (Y)
|
3 Participants
|
3 Participants
|
3 Participants
|
|
The Percentage of Subjects Achieved at Least 2-grade Improvement in the Subject Self-assessment Survey
>=2 grade improvement in self-assessment: Week 4 · No (N)
|
9 Participants
|
6 Participants
|
7 Participants
|
|
The Percentage of Subjects Achieved at Least 2-grade Improvement in the Subject Self-assessment Survey
>=2 grade improvement in self-assessment: Week 4 · Yes (Y)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
The Percentage of Subjects Achieved at Least 2-grade Improvement in the Subject Self-assessment Survey
>=2 grade improvement in self-assessment: Week 12 · No (N)
|
8 Participants
|
5 Participants
|
6 Participants
|
|
The Percentage of Subjects Achieved at Least 2-grade Improvement in the Subject Self-assessment Survey
>=2 grade improvement in self-assessment: Week 12 · Yes (Y)
|
1 Participants
|
2 Participants
|
2 Participants
|
|
The Percentage of Subjects Achieved at Least 2-grade Improvement in the Subject Self-assessment Survey
>=2 grade improvement in self-assessment: open-label week 4 · No (N)
|
8 Participants
|
5 Participants
|
2 Participants
|
|
The Percentage of Subjects Achieved at Least 2-grade Improvement in the Subject Self-assessment Survey
>=2 grade improvement in self-assessment: open-label week 4 · Yes (Y)
|
1 Participants
|
2 Participants
|
4 Participants
|
|
The Percentage of Subjects Achieved at Least 2-grade Improvement in the Subject Self-assessment Survey
>=2 grade improvement in self-assessment: open-label week 12 · No (N)
|
4 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Double blind phase weeks 4 and 12 and open label phase weeks 4 and 12Population: \[Not specified\]
Subject self- assessment survey was based on categories 0 to 4 (0 = no redness and no disease related lesions, 1 = very mild redness with few very small bumps, 2 = mild redness with many small and medium sized bumps, 3 = moderate redness with many small and medium sized bumps, 4 = severe redness with numerous small, medium, and large sized bumps) Negative values indicate improvement (0 = no change, -1 = 1-point improvement, -2 = 2-point improvement)
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo ointment applied topically once daily at bedtime for 12 weeks
|
Sirolimus 0.2%
n=7 Participants
Sirolimus 0.2% ointment applied topically once daily at bedtime for 12 weeks
|
Sirolimus 0.4%
n=8 Participants
Sirolimus 0.4% ointment applied topically once daily at bedtime for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in Self-Assessment
Change from baseline in self-assessment: Week 4 · 1 = 1-point worsening from baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Self-Assessment
Change from baseline in self-assessment: Week 4 · 0 = No change from baseline
|
8 Participants
|
3 Participants
|
3 Participants
|
|
Change From Baseline in Self-Assessment
Change from baseline in self-assessment: Week 4 · -1 = 1-point improvement from baseline
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Change From Baseline in Self-Assessment
Change from baseline in self-assessment: Week 4 · -2 = 2-point improvement from baseline
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Change From Baseline in Self-Assessment
Change from baseline in self-assessment: Week 4 · -3 = 3-point improvement from baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Self-Assessment
Change from Baseline in self-assessment: Week 12 · 1 = 1-point worsening from baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Self-Assessment
Change from Baseline in self-assessment: Week 12 · 0 = No change from baseline
|
6 Participants
|
1 Participants
|
1 Participants
|
|
Change From Baseline in Self-Assessment
Change from Baseline in self-assessment: Week 12 · -1 = 1-point improvement from baseline
|
2 Participants
|
4 Participants
|
5 Participants
|
|
Change From Baseline in Self-Assessment
Change from Baseline in self-assessment: Week 12 · -2 = 2-point improvement from baseline
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Change From Baseline in Self-Assessment
Change from Baseline in self-assessment: Week 12 · -3 = 3-point improvement from baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change From Baseline in Self-Assessment
Change from baseline in self- assessment: open-label week 14 · 1 = 1-point worsening from baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Self-Assessment
Change from baseline in self- assessment: open-label week 14 · 0 = No change from baseline
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Change From Baseline in Self-Assessment
Change from baseline in self- assessment: open-label week 14 · -1 = 1-point improvement from baseline
|
5 Participants
|
4 Participants
|
0 Participants
|
|
Change From Baseline in Self-Assessment
Change from baseline in self- assessment: open-label week 14 · -2 = 2-point improvement from baseline
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Change From Baseline in Self-Assessment
Change from baseline in self- assessment: open-label week 14 · -3 = 3-point improvement from baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change From Baseline in Self-Assessment
Change from baseline in self-assessment: open-label week 12 · 1 = 1-point worsening from baseline
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Self-Assessment
Change from baseline in self-assessment: open-label week 12 · 0 = No change from baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Change From Baseline in Self-Assessment
Change from baseline in self-assessment: open-label week 12 · -1 = 1-point improvement from baseline
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Change From Baseline in Self-Assessment
Change from baseline in self-assessment: open-label week 12 · -2 = 2-point improvement from baseline
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Change From Baseline in Self-Assessment
Change from baseline in self-assessment: open-label week 12 · -3 = 3-point improvement from baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Double-Blind: Sirolimus 0.2%
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Double-Blind: Sirolimus 0.4%
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Double-Blind: Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Open-label: Sirolimus 0.2%
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Open-label: Sirolimus 0.4%
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Open-label: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-Blind: Sirolimus 0.2%
n=7 participants at risk
Sirolimus 0.2% ointment applied topically once daily at bedtime for 12 weeks
|
Double-Blind: Sirolimus 0.4%
n=8 participants at risk
Sirolimus 0.4% ointment applied topically once daily at bedtime for 12 weeks
|
Double-Blind: Placebo
n=9 participants at risk
Placebo ointment applied topically once daily at bedtime for 12 weeks
|
Open-label: Sirolimus 0.2%
n=7 participants at risk
Sirolimus 0.2% ointment applied topically once daily at bedtime for 12 weeks
|
Open-label: Sirolimus 0.4%
n=7 participants at risk
Sirolimus 0.4% ointment applied topically once daily at bedtime for 12 weeks
|
Open-label: Placebo
n=9 participants at risk
Placebo ointment applied topically once daily at bedtime for 12 weeks
|
|---|---|---|---|---|---|---|
|
Psychiatric disorders
Agitation
|
0.00%
0/7 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/7 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
14.3%
1/7 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
Psychiatric disorders
Psychotic disorder due to a general medical condition
|
0.00%
0/7 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
14.3%
1/7 • Number of events 1 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
Other adverse events
| Measure |
Double-Blind: Sirolimus 0.2%
n=7 participants at risk
Sirolimus 0.2% ointment applied topically once daily at bedtime for 12 weeks
|
Double-Blind: Sirolimus 0.4%
n=8 participants at risk
Sirolimus 0.4% ointment applied topically once daily at bedtime for 12 weeks
|
Double-Blind: Placebo
n=9 participants at risk
Placebo ointment applied topically once daily at bedtime for 12 weeks
|
Open-label: Sirolimus 0.2%
n=7 participants at risk
Sirolimus 0.2% ointment applied topically once daily at bedtime for 12 weeks
|
Open-label: Sirolimus 0.4%
n=7 participants at risk
Sirolimus 0.4% ointment applied topically once daily at bedtime for 12 weeks
|
Open-label: Placebo
n=9 participants at risk
Placebo ointment applied topically once daily at bedtime for 12 weeks
|
|---|---|---|---|---|---|---|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/7 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
Reproductive system and breast disorders
Dsymenorrhoea
|
0.00%
0/7 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/7 • 30 weeks
|
25.0%
2/8 • Number of events 2 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
14.3%
1/7 • Number of events 1 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
14.3%
1/7 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
14.3%
1/7 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/7 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
14.3%
1/7 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/7 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
14.3%
1/7 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/7 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
14.3%
1/7 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/7 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
14.3%
1/7 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/7 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
14.3%
1/7 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/7 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/7 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
Gastrointestinal disorders
Mouth Ulceration
|
14.3%
1/7 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
General disorders
Application site reaction
|
14.3%
1/7 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
General disorders
Pain
|
0.00%
0/7 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/7 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
14.3%
1/7 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
Infections and infestations
Ear infection
|
0.00%
0/7 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/7 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
1/7 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
14.3%
1/7 • Number of events 1 • 30 weeks
|
22.2%
2/9 • Number of events 2 • 30 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/7 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/7 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
|
Psychiatric disorders
Obsessive thoughts
|
14.3%
1/7 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/7 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place