Trial Outcomes & Findings for A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris (NCT NCT03170388)
NCT ID: NCT03170388
Last Updated: 2021-11-10
Results Overview
Absolute change from Baseline to Week 12 in mean inflammatory lesion counts
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
741 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2021-11-10
Participant Flow
Participant milestones
| Measure |
IDP-126 Gel
Gel
IDP-126 Gel: Gel
|
IDP-126 Component A
Component A
IDP-126 Component A: Component A
|
IDP-126 Component B
Component B
IDP-126 Component B: Component B
|
IDP-126 Component C
Component C
IDP-126 Component C: Component C
|
IDP-126 Vehicle Gel
Vehicle Gel
IDP-126 Vehicle Gel: Vehicle Gel
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
147
|
150
|
146
|
150
|
148
|
|
Overall Study
COMPLETED
|
125
|
132
|
133
|
132
|
127
|
|
Overall Study
NOT COMPLETED
|
22
|
18
|
13
|
18
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris
Baseline characteristics by cohort
| Measure |
IDP-126 Gel
n=146 Participants
Gel
IDP-126 Gel: Gel
|
IDP-126 Component A
n=150 Participants
Component A
IDP-126 Component A: Component A
|
IDP-126 Component B
n=146 Participants
Component B
IDP-126 Component B: Component B
|
IDP-126 Component C
n=150 Participants
Component C
IDP-126 Component C: Component C
|
IDP-126 Vehicle Gel
n=148 Participants
Vehicle Gel
IDP-126 Vehicle Gel: Vehicle Gel
|
Total
n=740 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
17 years
n=5 Participants
|
17 years
n=7 Participants
|
17 years
n=5 Participants
|
17 years
n=4 Participants
|
17 years
n=21 Participants
|
17 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
89 Participants
n=21 Participants
|
453 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
287 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
50 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
126 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
98 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
95 Participants
n=21 Participants
|
512 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
39 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Baseline Evaluator's Global Severity Score
Moderate
|
124 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
127 Participants
n=21 Participants
|
623 Participants
n=10 Participants
|
|
Baseline Evaluator's Global Severity Score
Severe
|
22 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
117 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population.
Absolute change from Baseline to Week 12 in mean inflammatory lesion counts
Outcome measures
| Measure |
IDP-126 Gel
n=146 Participants
Gel
IDP-126 Gel: Gel
|
IDP-126 Component A
n=150 Participants
Component A
IDP-126 Component A: Component A
|
IDP-126 Component B
n=146 Participants
Component B
IDP-126 Component B: Component B
|
IDP-126 Component C
n=150 Participants
Component C
IDP-126 Component C: Component C
|
IDP-126 Vehicle Gel
n=148 Participants
Vehicle Gel
IDP-126 Vehicle Gel: Vehicle Gel
|
|---|---|---|---|---|---|
|
Inflammatory Lesion Counts
|
-29.9 lesions
Standard Deviation 11.86
|
-26.7 lesions
Standard Deviation 11.74
|
-24.8 lesions
Standard Deviation 11.71
|
-26.8 lesions
Standard Deviation 11.69
|
-19.6 lesions
Standard Deviation 12.12
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population.
Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts
Outcome measures
| Measure |
IDP-126 Gel
n=146 Participants
Gel
IDP-126 Gel: Gel
|
IDP-126 Component A
n=150 Participants
Component A
IDP-126 Component A: Component A
|
IDP-126 Component B
n=146 Participants
Component B
IDP-126 Component B: Component B
|
IDP-126 Component C
n=150 Participants
Component C
IDP-126 Component C: Component C
|
IDP-126 Vehicle Gel
n=148 Participants
Vehicle Gel
IDP-126 Vehicle Gel: Vehicle Gel
|
|---|---|---|---|---|---|
|
Non-inflammatory Lesion Counts
|
-35.5 lesions
Standard Deviation 16.25
|
-29.9 lesions
Standard Deviation 16.40
|
-27.8 lesions
Standard Deviation 15.97
|
-30.0 lesions
Standard Deviation 16.40
|
-21.8 lesions
Standard Deviation 16.58
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population.
Success was defined as at least a two grade reduction and clear or almost clear at Week 12. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.
Outcome measures
| Measure |
IDP-126 Gel
n=146 Participants
Gel
IDP-126 Gel: Gel
|
IDP-126 Component A
n=150 Participants
Component A
IDP-126 Component A: Component A
|
IDP-126 Component B
n=146 Participants
Component B
IDP-126 Component B: Component B
|
IDP-126 Component C
n=150 Participants
Component C
IDP-126 Component C: Component C
|
IDP-126 Vehicle Gel
n=148 Participants
Vehicle Gel
IDP-126 Vehicle Gel: Vehicle Gel
|
|---|---|---|---|---|---|
|
Percentage of Participants With Success on the Evaluator's Global Severity Score
|
52.5 percentage of participants
|
27.8 percentage of participants
|
30.5 percentage of participants
|
30.3 percentage of participants
|
8.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 2, 4, 8Population: One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population.
Absolute change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts
Outcome measures
| Measure |
IDP-126 Gel
n=146 Participants
Gel
IDP-126 Gel: Gel
|
IDP-126 Component A
n=150 Participants
Component A
IDP-126 Component A: Component A
|
IDP-126 Component B
n=146 Participants
Component B
IDP-126 Component B: Component B
|
IDP-126 Component C
n=150 Participants
Component C
IDP-126 Component C: Component C
|
IDP-126 Vehicle Gel
n=148 Participants
Vehicle Gel
IDP-126 Vehicle Gel: Vehicle Gel
|
|---|---|---|---|---|---|
|
Inflammatory Lesion Count Changes at Week 2, 4, and 8
Week 2
|
-14.0 lesions
Standard Deviation 11.62
|
-11.8 lesions
Standard Deviation 10.80
|
-13.8 lesions
Standard Deviation 10.50
|
-13.4 lesions
Standard Deviation 10.76
|
-9.2 lesions
Standard Deviation 9.58
|
|
Inflammatory Lesion Count Changes at Week 2, 4, and 8
Week 4
|
-21.0 lesions
Standard Deviation 10.33
|
-17.1 lesions
Standard Deviation 12.07
|
-18.8 lesions
Standard Deviation 12.05
|
-17.7 lesions
Standard Deviation 11.49
|
-14.8 lesions
Standard Deviation 10.26
|
|
Inflammatory Lesion Count Changes at Week 2, 4, and 8
Week 8
|
-25.8 lesions
Standard Deviation 11.97
|
-23.0 lesions
Standard Deviation 11.69
|
-23.1 lesions
Standard Deviation 13.95
|
-22.8 lesions
Standard Deviation 9.86
|
-17.5 lesions
Standard Deviation 10.86
|
SECONDARY outcome
Timeframe: Baseline to Week 2, 4, 8Population: One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population.
Absolute change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts
Outcome measures
| Measure |
IDP-126 Gel
n=146 Participants
Gel
IDP-126 Gel: Gel
|
IDP-126 Component A
n=150 Participants
Component A
IDP-126 Component A: Component A
|
IDP-126 Component B
n=146 Participants
Component B
IDP-126 Component B: Component B
|
IDP-126 Component C
n=150 Participants
Component C
IDP-126 Component C: Component C
|
IDP-126 Vehicle Gel
n=148 Participants
Vehicle Gel
IDP-126 Vehicle Gel: Vehicle Gel
|
|---|---|---|---|---|---|
|
Non-inflammatory Lesion Count Changes at Week 2, 4, and 8
Week 2
|
-12.9 lesions
Standard Deviation 12.90
|
-11.0 lesions
Standard Deviation 14.31
|
-11.2 lesions
Standard Deviation 10.97
|
-11.3 lesions
Standard Deviation 14.02
|
-9.2 lesions
Standard Deviation 11.94
|
|
Non-inflammatory Lesion Count Changes at Week 2, 4, and 8
Week 4
|
-21.4 lesions
Standard Deviation 14.33
|
-18.6 lesions
Standard Deviation 13.74
|
-15.8 lesions
Standard Deviation 13.77
|
-18.0 lesions
Standard Deviation 14.35
|
-13.7 lesions
Standard Deviation 11.78
|
|
Non-inflammatory Lesion Count Changes at Week 2, 4, and 8
Week 8
|
-30.5 lesions
Standard Deviation 15.95
|
-25.1 lesions
Standard Deviation 15.43
|
-21.7 lesions
Standard Deviation 16.08
|
-26.8 lesions
Standard Deviation 14.68
|
-17.6 lesions
Standard Deviation 15.29
|
SECONDARY outcome
Timeframe: Baseline to Week 2, 4, 8Population: One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population.
Percentage change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts
Outcome measures
| Measure |
IDP-126 Gel
n=146 Participants
Gel
IDP-126 Gel: Gel
|
IDP-126 Component A
n=150 Participants
Component A
IDP-126 Component A: Component A
|
IDP-126 Component B
n=146 Participants
Component B
IDP-126 Component B: Component B
|
IDP-126 Component C
n=150 Participants
Component C
IDP-126 Component C: Component C
|
IDP-126 Vehicle Gel
n=148 Participants
Vehicle Gel
IDP-126 Vehicle Gel: Vehicle Gel
|
|---|---|---|---|---|---|
|
Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8
Week 2
|
-35.89 percentage change
Standard Deviation 29.073
|
-30.27 percentage change
Standard Deviation 26.417
|
-35.10 percentage change
Standard Deviation 26.442
|
-35.23 percentage change
Standard Deviation 26.926
|
-24.18 percentage change
Standard Deviation 26.000
|
|
Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8
Week 4
|
-54.42 percentage change
Standard Deviation 22.683
|
-44.37 percentage change
Standard Deviation 28.511
|
-47.55 percentage change
Standard Deviation 28.040
|
-46.32 percentage change
Standard Deviation 27.664
|
-39.95 percentage change
Standard Deviation 27.304
|
|
Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8
Week 8
|
-66.07 percentage change
Standard Deviation 22.239
|
-59.07 percentage change
Standard Deviation 25.573
|
-59.55 percentage change
Standard Deviation 31.990
|
-60.10 percentage change
Standard Deviation 23.863
|
-46.61 percentage change
Standard Deviation 27.495
|
SECONDARY outcome
Timeframe: Baseline to Week 2, 4, 8Population: One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population.
Percentage change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts
Outcome measures
| Measure |
IDP-126 Gel
n=146 Participants
Gel
IDP-126 Gel: Gel
|
IDP-126 Component A
n=150 Participants
Component A
IDP-126 Component A: Component A
|
IDP-126 Component B
n=146 Participants
Component B
IDP-126 Component B: Component B
|
IDP-126 Component C
n=150 Participants
Component C
IDP-126 Component C: Component C
|
IDP-126 Vehicle Gel
n=148 Participants
Vehicle Gel
IDP-126 Vehicle Gel: Vehicle Gel
|
|---|---|---|---|---|---|
|
Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8
Week 8
|
-60.05 percentage change
Standard Deviation 25.164
|
-52.76 percentage change
Standard Deviation 27.916
|
-47.29 percentage change
Standard Deviation 32.982
|
-54.17 percentage change
Standard Deviation 26.530
|
-37.84 percentage change
Standard Deviation 29.933
|
|
Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8
Week 2
|
-27.07 percentage change
Standard Deviation 26.440
|
-23.39 percentage change
Standard Deviation 30.433
|
-23.72 percentage change
Standard Deviation 22.845
|
-24.91 percentage change
Standard Deviation 28.698
|
-19.68 percentage change
Standard Deviation 23.194
|
|
Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8
Week 4
|
-43.17 percentage change
Standard Deviation 27.162
|
-39.28 percentage change
Standard Deviation 26.422
|
-33.84 percentage change
Standard Deviation 29.592
|
-38.14 percentage change
Standard Deviation 27.765
|
-29.53 percentage change
Standard Deviation 26.025
|
SECONDARY outcome
Timeframe: Baseline to Week 2, 4, and 8Population: One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population.
Success was defined as at least a two grade reduction and clear or almost clear at the visit. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.
Outcome measures
| Measure |
IDP-126 Gel
n=146 Participants
Gel
IDP-126 Gel: Gel
|
IDP-126 Component A
n=150 Participants
Component A
IDP-126 Component A: Component A
|
IDP-126 Component B
n=146 Participants
Component B
IDP-126 Component B: Component B
|
IDP-126 Component C
n=150 Participants
Component C
IDP-126 Component C: Component C
|
IDP-126 Vehicle Gel
n=148 Participants
Vehicle Gel
IDP-126 Vehicle Gel: Vehicle Gel
|
|---|---|---|---|---|---|
|
Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8
Week 2
|
1.49 percentage of participants
|
1.35 percentage of participants
|
0.71 percentage of participants
|
2.68 percentage of participants
|
0.00 percentage of participants
|
|
Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8
Week 4
|
8.17 percentage of participants
|
6.77 percentage of participants
|
2.79 percentage of participants
|
4.27 percentage of participants
|
1.36 percentage of participants
|
|
Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8
Week 8
|
20.46 percentage of participants
|
15.97 percentage of participants
|
15.26 percentage of participants
|
15.75 percentage of participants
|
3.51 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 2, 4, and 8Population: One participant in the IDP-126 Gel group did not receive study medication and thus is not included in the demography population.
Two grade success was defined as at least a two grade reduction. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.
Outcome measures
| Measure |
IDP-126 Gel
n=146 Participants
Gel
IDP-126 Gel: Gel
|
IDP-126 Component A
n=150 Participants
Component A
IDP-126 Component A: Component A
|
IDP-126 Component B
n=146 Participants
Component B
IDP-126 Component B: Component B
|
IDP-126 Component C
n=150 Participants
Component C
IDP-126 Component C: Component C
|
IDP-126 Vehicle Gel
n=148 Participants
Vehicle Gel
IDP-126 Vehicle Gel: Vehicle Gel
|
|---|---|---|---|---|---|
|
Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8
Week 2
|
2.95 percentage of participants
|
2.78 percentage of participants
|
1.45 percentage of participants
|
5.44 percentage of participants
|
1.36 percentage of participants
|
|
Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8
Week 4
|
11.46 percentage of participants
|
10.53 percentage of participants
|
5.83 percentage of participants
|
8.51 percentage of participants
|
2.12 percentage of participants
|
|
Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8
Week 8
|
28.74 percentage of participants
|
22.79 percentage of participants
|
19.97 percentage of participants
|
20.66 percentage of participants
|
4.43 percentage of participants
|
Adverse Events
IDP-126 Gel
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
IDP-126 Component A
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
IDP-126 Component B
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
IDP-126 Component C
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
IDP-126 Vehicle Gel
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDP-126 Gel
n=141 participants at risk
Gel
IDP-126 Gel: Gel
|
IDP-126 Component A
n=146 participants at risk
Component A
IDP-126 Component A: Component A
|
IDP-126 Component B
n=144 participants at risk
Component B
IDP-126 Component B: Component B
|
IDP-126 Component C
n=148 participants at risk
Component C
IDP-126 Component C: Component C
|
IDP-126 Vehicle Gel
n=146 participants at risk
Vehicle Gel
IDP-126 Vehicle Gel: Vehicle Gel
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Sickle cell anemia with crisis
|
0.71%
1/141 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
0.00%
0/146 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
0.00%
0/144 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
0.00%
0/148 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
0.00%
0/146 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/141 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
0.00%
0/146 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
0.00%
0/144 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
0.68%
1/148 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
0.00%
0/146 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
0.00%
0/141 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
0.00%
0/146 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
0.00%
0/144 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
0.68%
1/148 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
0.00%
0/146 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/141 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
0.00%
0/146 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
0.00%
0/144 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
0.68%
1/148 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
0.00%
0/146 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
Other adverse events
| Measure |
IDP-126 Gel
n=141 participants at risk
Gel
IDP-126 Gel: Gel
|
IDP-126 Component A
n=146 participants at risk
Component A
IDP-126 Component A: Component A
|
IDP-126 Component B
n=144 participants at risk
Component B
IDP-126 Component B: Component B
|
IDP-126 Component C
n=148 participants at risk
Component C
IDP-126 Component C: Component C
|
IDP-126 Vehicle Gel
n=146 participants at risk
Vehicle Gel
IDP-126 Vehicle Gel: Vehicle Gel
|
|---|---|---|---|---|---|
|
General disorders
Application Site Pain
|
7.8%
11/141 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
11.0%
16/146 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
0.69%
1/144 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
3.4%
5/148 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
0.68%
1/146 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
|
General disorders
Application Site Dryness
|
6.4%
9/141 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
5.5%
8/146 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
1.4%
2/144 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
6.1%
9/148 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
0.68%
1/146 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
7.1%
10/141 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
3.4%
5/146 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
2.1%
3/144 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
3.4%
5/148 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
3.4%
5/146 • 12 weeks
There were 6 IDP-126, 4 Component A, 2 Component B, 2 Component C, and 2 Vehicle participants excluded from the adverse event analysis since they did not have post-baseline safety evaluations.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Please contact sponsor for details.
- Publication restrictions are in place
Restriction type: OTHER