Trial Outcomes & Findings for An Ascending Multiple Dose Study of VTP-38543 in Adult Participants With Mild to Moderate Atopic Dermatitis (NCT NCT02655679)
NCT ID: NCT02655679
Last Updated: 2019-02-15
Results Overview
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The number of participants with AEs related to treatment are reported.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
104 participants
Primary outcome timeframe
Baseline (Day 0) to Day 35
Results posted on
2019-02-15
Participant Flow
Participant milestones
| Measure |
VTP- 38543 0.05%
VTP-38543 0.05% administered topically every 12 hours for 28 days.
|
VTP- 38543 0.15%
VTP-38543 0.15% administered topically every 12 hours for 28 days.
|
Vehicle Without Transcutol®P
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
|
VTP-38543 1%
VTP-38543 1% administered topically every 12 hours for 28 days.
|
Vehicle With Transcutol®P
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
20
|
24
|
20
|
|
Overall Study
Received Study Drug (Safety Population)
|
20
|
19
|
20
|
24
|
20
|
|
Overall Study
COMPLETED
|
18
|
16
|
19
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
1
|
4
|
1
|
Reasons for withdrawal
| Measure |
VTP- 38543 0.05%
VTP-38543 0.05% administered topically every 12 hours for 28 days.
|
VTP- 38543 0.15%
VTP-38543 0.15% administered topically every 12 hours for 28 days.
|
Vehicle Without Transcutol®P
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
|
VTP-38543 1%
VTP-38543 1% administered topically every 12 hours for 28 days.
|
Vehicle With Transcutol®P
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
3
|
1
|
|
Overall Study
Inability to Comply with the Protocol
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
1
|
0
|
|
Overall Study
Other Miscellaneous Reasons
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
An Ascending Multiple Dose Study of VTP-38543 in Adult Participants With Mild to Moderate Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
VTP- 38543 0.05%
n=20 Participants
VTP-38543 0.05% administered topically every 12 hours for 28 days.
|
VTP- 38543 0.15%
n=19 Participants
VTP-38543 0.15% administered topically every 12 hours for 28 days.
|
Vehicle Without Transcutol®P
n=20 Participants
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
|
VTP-38543 1%
n=24 Participants
VTP-38543 1% administered topically every 12 hours for 28 days.
|
Vehicle With Transcutol®P
n=20 Participants
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.2 years
STANDARD_DEVIATION 15.79 • n=5 Participants
|
36.8 years
STANDARD_DEVIATION 13.39 • n=7 Participants
|
30.8 years
STANDARD_DEVIATION 11.59 • n=5 Participants
|
35.7 years
STANDARD_DEVIATION 10.51 • n=4 Participants
|
30.9 years
STANDARD_DEVIATION 11.73 • n=21 Participants
|
34.1 years
STANDARD_DEVIATION 12.67 • n=10 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
55 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
48 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Day 35Population: Safety population included randomized participants who received at least one dose of study medication.
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The number of participants with AEs related to treatment are reported.
Outcome measures
| Measure |
VTP-38543 0.05%
n=20 Participants
VTP-38543 0.05% administered topically every 12 hours for 28 days.
|
VTP-38543 0.15%
n=19 Participants
VTP-38543 0.15% administered topically every 12 hours for 28 days.
|
Vehicle Without Transcutol®P
n=20 Participants
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
|
VTP-38543 1%
n=24 Participants
VTP-38543 1% administered topically every 12 hours for 28 days.
|
Vehicle With Transcutol®P
n=20 Participants
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-related Adverse Events (AEs)
|
1 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Day 35Population: Safety population included randomized participants who received at least one dose of study medication.
Clinical Laboratory tests included chemistry, hematology and urinalysis tests collected during the study. The investigator determined if the changes in laboratory results were clinically significant.
Outcome measures
| Measure |
VTP-38543 0.05%
n=20 Participants
VTP-38543 0.05% administered topically every 12 hours for 28 days.
|
VTP-38543 0.15%
n=19 Participants
VTP-38543 0.15% administered topically every 12 hours for 28 days.
|
Vehicle Without Transcutol®P
n=20 Participants
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
|
VTP-38543 1%
n=24 Participants
VTP-38543 1% administered topically every 12 hours for 28 days.
|
Vehicle With Transcutol®P
n=20 Participants
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Day 35Population: Safety population included randomized participants who received at least one dose of study medication.
Vital signs included blood pressure, pulse, respiration rate and body temperature. The investigator determined if the changes in vital sign results were clinically significant.
Outcome measures
| Measure |
VTP-38543 0.05%
n=20 Participants
VTP-38543 0.05% administered topically every 12 hours for 28 days.
|
VTP-38543 0.15%
n=19 Participants
VTP-38543 0.15% administered topically every 12 hours for 28 days.
|
Vehicle Without Transcutol®P
n=20 Participants
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
|
VTP-38543 1%
n=24 Participants
VTP-38543 1% administered topically every 12 hours for 28 days.
|
Vehicle With Transcutol®P
n=20 Participants
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Day 35Population: Safety population included randomized participants who received at least one dose of study medication.
A standard 12-lead ECG was performed. The investigator determined if the changes in ECG results were clinically significant.
Outcome measures
| Measure |
VTP-38543 0.05%
n=20 Participants
VTP-38543 0.05% administered topically every 12 hours for 28 days.
|
VTP-38543 0.15%
n=19 Participants
VTP-38543 0.15% administered topically every 12 hours for 28 days.
|
Vehicle Without Transcutol®P
n=20 Participants
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
|
VTP-38543 1%
n=24 Participants
VTP-38543 1% administered topically every 12 hours for 28 days.
|
Vehicle With Transcutol®P
n=20 Participants
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)Population: Pharmacokinetic (PK) population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.
Outcome measures
| Measure |
VTP-38543 0.05%
n=8 Participants
VTP-38543 0.05% administered topically every 12 hours for 28 days.
|
VTP-38543 0.15%
n=8 Participants
VTP-38543 0.15% administered topically every 12 hours for 28 days.
|
Vehicle Without Transcutol®P
n=8 Participants
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
|
VTP-38543 1%
VTP-38543 1% administered topically every 12 hours for 28 days.
|
Vehicle With Transcutol®P
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
|
|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) for VTP-38543-001
Day 0
|
0.546 ng/mL
Standard Deviation 1.16
|
0.221 ng/mL
Standard Deviation 0.175
|
2.34 ng/mL
Standard Deviation 3.29
|
—
|
—
|
|
Maximum Plasma Concentration (Cmax) for VTP-38543-001
Day 27
|
2.81 ng/mL
Standard Deviation 5.35
|
2.28 ng/mL
Standard Deviation 1.68
|
13.4 ng/mL
Standard Deviation 12.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)Population: PK population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.
Outcome measures
| Measure |
VTP-38543 0.05%
n=8 Participants
VTP-38543 0.05% administered topically every 12 hours for 28 days.
|
VTP-38543 0.15%
n=8 Participants
VTP-38543 0.15% administered topically every 12 hours for 28 days.
|
Vehicle Without Transcutol®P
n=8 Participants
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
|
VTP-38543 1%
VTP-38543 1% administered topically every 12 hours for 28 days.
|
Vehicle With Transcutol®P
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
|
|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentrations (Tmax) for VTP-38543
Day 0
|
5.5 hour
Interval 2.0 to 9.0
|
9 hour
Interval 2.0 to 9.0
|
4 hour
Interval 2.0 to 9.0
|
—
|
—
|
|
Time to Maximum Plasma Concentrations (Tmax) for VTP-38543
Day 27
|
1 hour
Interval 0.0 to 4.0
|
6.5 hour
Interval 2.0 to 24.0
|
4 hour
Interval 4.0 to 9.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)Population: PK population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.
Outcome measures
| Measure |
VTP-38543 0.05%
n=8 Participants
VTP-38543 0.05% administered topically every 12 hours for 28 days.
|
VTP-38543 0.15%
n=8 Participants
VTP-38543 0.15% administered topically every 12 hours for 28 days.
|
Vehicle Without Transcutol®P
n=8 Participants
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
|
VTP-38543 1%
VTP-38543 1% administered topically every 12 hours for 28 days.
|
Vehicle With Transcutol®P
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUClast) for VTP-38543
Day 0
|
2.27 ng*hr/mL
Standard Deviation 4.23
|
1.35 ng*hr/mL
Standard Deviation 1.41
|
20.0 ng*hr/mL
Standard Deviation 28.2
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUClast) for VTP-38543
Day 27
|
129 ng*hr/mL
Standard Deviation 257
|
104 ng*hr/mL
Standard Deviation 77.5
|
720 ng*hr/mL
Standard Deviation 798
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)Population: PK population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.
Outcome measures
| Measure |
VTP-38543 0.05%
n=8 Participants
VTP-38543 0.05% administered topically every 12 hours for 28 days.
|
VTP-38543 0.15%
n=8 Participants
VTP-38543 0.15% administered topically every 12 hours for 28 days.
|
Vehicle Without Transcutol®P
n=8 Participants
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
|
VTP-38543 1%
VTP-38543 1% administered topically every 12 hours for 28 days.
|
Vehicle With Transcutol®P
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve, From Time 0 to 12 Hours (AUC0-12hr) for VTP-38543
Day 0
|
2.27 ng*hr/mL
Standard Deviation 4.23
|
1.35 ng*hr/mL
Standard Deviation 1.41
|
20.0 ng*hr/mL
Standard Deviation 28.2
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve, From Time 0 to 12 Hours (AUC0-12hr) for VTP-38543
Day 27
|
23.6 ng*hr/mL
Standard Deviation 44.8
|
22.2 ng*hr/mL
Standard Deviation 18.2
|
144 ng*hr/mL
Standard Deviation 144
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)Population: PK Population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.
Outcome measures
| Measure |
VTP-38543 0.05%
n=8 Participants
VTP-38543 0.05% administered topically every 12 hours for 28 days.
|
VTP-38543 0.15%
n=8 Participants
VTP-38543 0.15% administered topically every 12 hours for 28 days.
|
Vehicle Without Transcutol®P
n=8 Participants
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
|
VTP-38543 1%
VTP-38543 1% administered topically every 12 hours for 28 days.
|
Vehicle With Transcutol®P
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
|
|---|---|---|---|---|---|
|
Elimination Half-life (t½) for VTP-38543
Day 27
|
58.6 hour
Standard Deviation 14.5
|
47.2 hour
Standard Deviation 12.2
|
246 hour
Standard Deviation 349
|
—
|
—
|
|
Elimination Half-life (t½) for VTP-38543
Day 0
|
NA hour
Standard Deviation NA
t1/2 was not achieved at Day 0.
|
NA hour
Standard Deviation NA
t1/2 was not achieved at Day 0.
|
NA hour
Standard Deviation NA
t1/2 was not achieved at Day 0.
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Day 28Population: Modified intent-to-treat (mITT) population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
Percent BSA was estimated using the palmar surface of the participant's hand up to the proximal interphalangeal joint, including the thumb, to approximate 1% of the participant's BSA. The overall BSA affected by atopic dermatitis was evaluated from 0 to 100% and divided by 5 for a maximum of 20. A negative percentage change indicates improvement.
Outcome measures
| Measure |
VTP-38543 0.05%
n=17 Participants
VTP-38543 0.05% administered topically every 12 hours for 28 days.
|
VTP-38543 0.15%
n=16 Participants
VTP-38543 0.15% administered topically every 12 hours for 28 days.
|
Vehicle Without Transcutol®P
n=18 Participants
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
|
VTP-38543 1%
n=19 Participants
VTP-38543 1% administered topically every 12 hours for 28 days.
|
Vehicle With Transcutol®P
n=19 Participants
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline in Total Body Surface Area (BSA)
|
-39.09 percentage change in total BSA
Standard Deviation 29.233
|
-9.46 percentage change in total BSA
Standard Deviation 52.978
|
-17.39 percentage change in total BSA
Standard Deviation 55.588
|
-9.44 percentage change in total BSA
Standard Deviation 48.063
|
-28.51 percentage change in total BSA
Standard Deviation 29.398
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Day 28Population: mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
The investigator assessed the participant's atopic dermatitis using the 5-point IGA where 0=clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting) to 4=Severe disease (Deep/bright red erythema with severe induration/papulation with oozing/crusting). A negative percentage change indicates improvement.
Outcome measures
| Measure |
VTP-38543 0.05%
n=17 Participants
VTP-38543 0.05% administered topically every 12 hours for 28 days.
|
VTP-38543 0.15%
n=16 Participants
VTP-38543 0.15% administered topically every 12 hours for 28 days.
|
Vehicle Without Transcutol®P
n=18 Participants
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
|
VTP-38543 1%
n=19 Participants
VTP-38543 1% administered topically every 12 hours for 28 days.
|
Vehicle With Transcutol®P
n=19 Participants
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline in Investigator Global Assessments (IGA) Score
|
-12.7 percentage change in IGA score
Standard Deviation 25.36
|
-16.7 percentage change in IGA score
Standard Deviation 34.96
|
-19.4 percentage change in IGA score
Standard Deviation 32.46
|
-6.1 percentage change in IGA score
Standard Deviation 34.79
|
-13.2 percentage change in IGA score
Standard Deviation 20.47
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Day 28Population: mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
The investigator assessed severity of atopic dermatitis (AD) using scoring atopic dermatitis (SCORAD) score obtained from different individual scales. 6-items: erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness were graded on a 4-point scale where 0=Absent to 3=Severe. The individual scores were added together to get a score of 0 to 18 that was multiplied by 3.5 for a score of 0 to 63. The overall BSA affected by AD (0 to 100 %) was divided by 5 for a score 0 to 20. The participant used a 10-point Visual Analog Scale (VAS) to evaluate loss of sleep and the occurrence of pruritus averaged over the last 3 days where 0=None to Worst Imaginable. The sum of the 2 VAS scores was 0 to 20. The above measures were added together for a total possible SCORAD score of 0 (best) to 103 (worst). A negative percentage change indicates improvement.
Outcome measures
| Measure |
VTP-38543 0.05%
n=17 Participants
VTP-38543 0.05% administered topically every 12 hours for 28 days.
|
VTP-38543 0.15%
n=16 Participants
VTP-38543 0.15% administered topically every 12 hours for 28 days.
|
Vehicle Without Transcutol®P
n=18 Participants
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
|
VTP-38543 1%
n=19 Participants
VTP-38543 1% administered topically every 12 hours for 28 days.
|
Vehicle With Transcutol®P
n=19 Participants
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score
|
-23.473 percentage change in SCORAD score
Standard Deviation 30.1085
|
-17.300 percentage change in SCORAD score
Standard Deviation 34.7270
|
-24.453 percentage change in SCORAD score
Standard Deviation 35.6572
|
-14.483 percentage change in SCORAD score
Standard Deviation 32.2743
|
-18.630 percentage change in SCORAD score
Standard Deviation 26.0370
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Day 28Population: mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
The investigator assessed four body regions: Head and neck, Upper extremities, Trunk including axillae and groin, and Lower extremities including buttocks. Each body region was scored based on BSA where 0=No involvement to 6=90-100%. Each body region was assessed for erythema, infiltration/papulation, excoriation and lichenification using a 4-point scale where 0=None to 3=Severe. EASI total score was determined by combining the individual scores for each of the 4 body regions. The total for each region was calculated by \[erythema + infiltration+ excoriation + lichenification \* area involvement \* a constant (constants Head and Neck=0.1, Upper Limbs=0.2, Trunk=0.3, Lower Limbs=0.4)\]. The EASI total score was determined by combining the individual scores for each of the 4 body regions for a total possible score of 0 (best) to 72 (worst). A negative percentage change indicates improvement.
Outcome measures
| Measure |
VTP-38543 0.05%
n=17 Participants
VTP-38543 0.05% administered topically every 12 hours for 28 days.
|
VTP-38543 0.15%
n=16 Participants
VTP-38543 0.15% administered topically every 12 hours for 28 days.
|
Vehicle Without Transcutol®P
n=18 Participants
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
|
VTP-38543 1%
n=19 Participants
VTP-38543 1% administered topically every 12 hours for 28 days.
|
Vehicle With Transcutol®P
n=19 Participants
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline Eczema Area and Severity Index (EASI)
|
-36.26 percentage change in EASI
Standard Deviation 29.832
|
-9.16 percentage change in EASI
Standard Deviation 66.519
|
-26.99 percentage change in EASI
Standard Deviation 46.549
|
-12.52 percentage change in EASI
Standard Deviation 58.819
|
-27.10 percentage change in EASI
Standard Deviation 36.323
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Day 28Population: mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
The participant used a 10-point VAS to assess the occurrence of pruritus (itchy skin) over the last 3 days where 0= None to 10=Worst Imaginable for a total possible score of 0 to 10. A negative percentage change indicates improvement.
Outcome measures
| Measure |
VTP-38543 0.05%
n=17 Participants
VTP-38543 0.05% administered topically every 12 hours for 28 days.
|
VTP-38543 0.15%
n=16 Participants
VTP-38543 0.15% administered topically every 12 hours for 28 days.
|
Vehicle Without Transcutol®P
n=18 Participants
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
|
VTP-38543 1%
n=19 Participants
VTP-38543 1% administered topically every 12 hours for 28 days.
|
Vehicle With Transcutol®P
n=19 Participants
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline in Pruritus VAS Score
|
4.20 percentage change in pruritis VAS score
Standard Deviation 112.105
|
-20.07 percentage change in pruritis VAS score
Standard Deviation 48.771
|
-26.75 percentage change in pruritis VAS score
Standard Deviation 47.715
|
-25.80 percentage change in pruritis VAS score
Standard Deviation 42.232
|
-34.68 percentage change in pruritis VAS score
Standard Deviation 54.612
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Day 28Population: mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
The participant used a 10-point VAS to evaluate loss of sleep averaged over the last 3 days where 0= None to 10=Worst imaginable for a total possible score of 0 to 10. A negative percentage change indicates improvement.
Outcome measures
| Measure |
VTP-38543 0.05%
n=15 Participants
VTP-38543 0.05% administered topically every 12 hours for 28 days.
|
VTP-38543 0.15%
n=13 Participants
VTP-38543 0.15% administered topically every 12 hours for 28 days.
|
Vehicle Without Transcutol®P
n=15 Participants
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
|
VTP-38543 1%
n=18 Participants
VTP-38543 1% administered topically every 12 hours for 28 days.
|
Vehicle With Transcutol®P
n=13 Participants
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline in VAS Sleep Score
|
-29.40 percentage change in VAS sleep score
Standard Deviation 61.845
|
-19.74 percentage change in VAS sleep score
Standard Deviation 78.382
|
2.73 percentage change in VAS sleep score
Standard Deviation 113.782
|
-29.98 percentage change in VAS sleep score
Standard Deviation 53.672
|
-30.85 percentage change in VAS sleep score
Standard Deviation 39.259
|
Adverse Events
VTP- 38543 0.05%
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
VTP- 38543 0.15%
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Vehicle Without Transcutol®P
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
VTP-38543 1%
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Vehicle With Transcutol®P
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
VTP- 38543 0.05%
n=20 participants at risk
VTP-38543 0.05% administered topically every 12 hours for 28 days.
|
VTP- 38543 0.15%
n=19 participants at risk
VTP-38543 0.15% administered topically every 12 hours for 28 days.
|
Vehicle Without Transcutol®P
n=20 participants at risk
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
|
VTP-38543 1%
n=24 participants at risk
VTP-38543 1% administered topically every 12 hours for 28 days.
|
Vehicle With Transcutol®P
n=20 participants at risk
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
|
|---|---|---|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.3%
1/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.3%
1/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
4.2%
1/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.3%
1/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.3%
1/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
10.0%
2/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
4.2%
1/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
2/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.3%
1/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.3%
1/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
2/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
15.8%
3/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
15.0%
3/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
4.2%
1/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
General disorders
Application site reaction
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
8.3%
2/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
General disorders
Fatigue
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
4.2%
1/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.3%
1/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
General disorders
Chest discomfort
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
4.2%
1/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Eye disorders
Dry eye
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
4.2%
1/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Infections and infestations
Body tinea
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
4.2%
1/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
4.2%
1/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Endocrine disorders
Hypothyroidism
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.3%
1/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.3%
1/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
General disorders
Application site pain
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.3%
1/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
12.5%
3/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
General disorders
Application site pruritus
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.3%
1/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
4.2%
1/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
General disorders
Administration site pruritus
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
General disorders
Chest pain
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
General disorders
Chills
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Infections and infestations
Cellulitis
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.3%
1/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.3%
1/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.3%
1/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
|
Injury, poisoning and procedural complications
Sunburn
|
5.0%
1/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/19 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/24 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/20 • First dose of study drug to the last visit (Up to Day 35)
Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER