Trial Outcomes & Findings for Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris (NCT NCT04214652)
NCT ID: NCT04214652
Last Updated: 2024-02-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
180 participants
Primary outcome timeframe
12 weeks
Results posted on
2024-02-01
Participant Flow
Participant milestones
| Measure |
IDP-126 Gel
IDP-126 Gel: IDP-126 Gel applied topically to the face once daily for 12 weeks.
|
IDP-126 Vehicle Gel
IDP-126 Vehicle Gel: IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
120
|
60
|
|
Overall Study
COMPLETED
|
107
|
56
|
|
Overall Study
NOT COMPLETED
|
13
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris
Baseline characteristics by cohort
| Measure |
IDP-126 Gel
n=120 Participants
IDP-126 Gel: IDP-126 Gel applied topically to the face once daily for 12 weeks.
|
IDP-126 Vehicle Gel
n=60 Participants
IDP-126 Vehicle Gel: IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Age, Continuous
|
17.0 years
n=93 Participants
|
19.5 years
n=4 Participants
|
18.0 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
106 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
74 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
94 Participants
n=93 Participants
|
53 Participants
n=4 Participants
|
147 Participants
n=27 Participants
|
|
Baseline Evaluator's Global Severity Score
Moderate
|
109 Participants
n=93 Participants
|
57 Participants
n=4 Participants
|
166 Participants
n=27 Participants
|
|
Baseline Evaluator's Global Severity Score
Severe
|
11 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
IDP-126 Gel
n=120 Participants
IDP-126 Gel: IDP-126 Gel applied topically to the face once daily for 12 weeks.
|
IDP-126 Vehicle Gel
n=60 Participants
IDP-126 Vehicle Gel: IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.
|
|---|---|---|
|
Absolute Change From Baseline to Week 12 in Inflammatory Lesion Counts
|
-30.1 lesion counts
Standard Deviation 9.64
|
-20.8 lesion counts
Standard Deviation 9.90
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
IDP-126 Gel
n=120 Participants
IDP-126 Gel: IDP-126 Gel applied topically to the face once daily for 12 weeks.
|
IDP-126 Vehicle Gel
n=60 Participants
IDP-126 Vehicle Gel: IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.
|
|---|---|---|
|
Absolute Change From Baseline to Week 12 in Non-inflammatory Lesion Counts
|
-35.2 lesion counts
Standard Deviation 14.48
|
-22.0 lesion counts
Standard Deviation 14.27
|
PRIMARY outcome
Timeframe: 12 weeksSuccess 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=120 Participants
IDP-126 Gel: IDP-126 Gel applied topically to the face once daily for 12 weeks.
|
IDP-126 Vehicle Gel
n=60 Participants
IDP-126 Vehicle Gel: IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Success on the Evaluator's Global Severity Score
|
50.5 percentage of participants
|
20.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 4, 8, 12Outcome measures
| Measure |
IDP-126 Gel
n=120 Participants
IDP-126 Gel: IDP-126 Gel applied topically to the face once daily for 12 weeks.
|
IDP-126 Vehicle Gel
n=60 Participants
IDP-126 Vehicle Gel: IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.
|
|---|---|---|
|
Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12
Week 4
|
-57.40 percentage change
Standard Deviation 29.412
|
-41.62 percentage change
Standard Deviation 26.854
|
|
Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12
Week 8
|
-70.38 percentage change
Standard Deviation 27.018
|
-47.62 percentage change
Standard Deviation 26.343
|
|
Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12
Week 12
|
-80.13 percentage change
Standard Deviation 25.274
|
-56.18 percentage change
Standard Deviation 25.149
|
SECONDARY outcome
Timeframe: Baseline to Week 4, 8, 12Outcome measures
| Measure |
IDP-126 Gel
n=120 Participants
IDP-126 Gel: IDP-126 Gel applied topically to the face once daily for 12 weeks.
|
IDP-126 Vehicle Gel
n=60 Participants
IDP-126 Vehicle Gel: IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.
|
|---|---|---|
|
Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12
Week 4
|
-45.07 percentage change
Standard Deviation 32.748
|
-33.05 percentage change
Standard Deviation 29.290
|
|
Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12
Week 8
|
-60.62 percentage change
Standard Deviation 28.041
|
-45.54 percentage change
Standard Deviation 26.604
|
|
Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12
Week 12
|
-73.26 percentage change
Standard Deviation 27.640
|
-48.99 percentage change
Standard Deviation 27.345
|
SECONDARY outcome
Timeframe: 12 weeksThe 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=120 Participants
IDP-126 Gel: IDP-126 Gel applied topically to the face once daily for 12 weeks.
|
IDP-126 Vehicle Gel
n=60 Participants
IDP-126 Vehicle Gel: IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With at Least a Two Grade Reduction on the Evaluator's Global Severity Score at Week 12
|
55.2 percentage of participants
|
23.1 percentage of participants
|
Adverse Events
IDP-126 Gel
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
IDP-126 Vehicle Gel
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IDP-126 Gel
n=120 participants at risk
IDP-126 Gel: IDP-126 Gel applied topically to the face once daily for 12 weeks.
|
IDP-126 Vehicle Gel
n=60 participants at risk
IDP-126 Vehicle Gel: IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.
|
|---|---|---|
|
General disorders
Application site pain
|
15.0%
18/120 • 12 weeks
|
1.7%
1/60 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Please contact sponsor for details.
- Publication restrictions are in place
Restriction type: OTHER