Trial Outcomes & Findings for Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris (NCT NCT02965456)
NCT ID: NCT02965456
Last Updated: 2019-12-18
Results Overview
Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.
COMPLETED
PHASE3
820 participants
Baseline (Day 0), Week 12
2019-12-18
Participant Flow
Participants were randomized in a 1:1 ratio to receive either IDP-121(tretinoin 0.05 percent \[%\]) Lotion or IDP-121 Vehicle Lotion.
Participant milestones
| Measure |
IDP-121 Lotion
IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
|
IDP-121 Vehicle Lotion
IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
413
|
407
|
|
Overall Study
Intent-to-treat (ITT) Population
|
413
|
407
|
|
Overall Study
Safety Population
|
389
|
398
|
|
Overall Study
COMPLETED
|
342
|
364
|
|
Overall Study
NOT COMPLETED
|
71
|
43
|
Reasons for withdrawal
| Measure |
IDP-121 Lotion
IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
|
IDP-121 Vehicle Lotion
IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
40
|
18
|
|
Overall Study
Subject Request
|
22
|
13
|
|
Overall Study
Withdrawal by Parent or Guardian
|
3
|
6
|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Noncompliance with Study Drug
|
1
|
1
|
|
Overall Study
Worsening Condition
|
0
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Participant ran out of study drug
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
Baseline characteristics by cohort
| Measure |
IDP-121 Lotion
n=413 Participants
IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
|
IDP-121 Vehicle Lotion
n=407 Participants
IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
|
Total
n=820 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.5 years
STANDARD_DEVIATION 7.21 • n=5 Participants
|
20.7 years
STANDARD_DEVIATION 7.63 • n=7 Participants
|
20.6 years
STANDARD_DEVIATION 7.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
204 Participants
n=5 Participants
|
229 Participants
n=7 Participants
|
433 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
209 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
387 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
225 Participants
n=5 Participants
|
227 Participants
n=7 Participants
|
452 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
187 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
367 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
90 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
297 Participants
n=5 Participants
|
311 Participants
n=7 Participants
|
608 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Evaluator's Global Severity Score (EGSS)
0 - Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Evaluator's Global Severity Score (EGSS)
1 - Almost Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Evaluator's Global Severity Score (EGSS)
2 - Mild
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Evaluator's Global Severity Score (EGSS)
3 - Moderate
|
369 Participants
n=5 Participants
|
356 Participants
n=7 Participants
|
725 Participants
n=5 Participants
|
|
Evaluator's Global Severity Score (EGSS)
4 - Severe
|
44 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Noninflammatory Lesion Count
|
46.1 lesion count
STANDARD_DEVIATION 19.25 • n=5 Participants
|
48.3 lesion count
STANDARD_DEVIATION 19.91 • n=7 Participants
|
47.2 lesion count
STANDARD_DEVIATION 19.60 • n=5 Participants
|
|
Inflammatory Lesion Count
|
26.5 lesion Count
STANDARD_DEVIATION 5.42 • n=5 Participants
|
26.0 lesion Count
STANDARD_DEVIATION 5.25 • n=7 Participants
|
26.2 lesion Count
STANDARD_DEVIATION 5.34 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Week 12Population: ITT population included all randomized participants who received study drug. Multiple imputation (Markov Chain Monte Carlo \[MCMC\]) was used to impute missing values.
Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.
Outcome measures
| Measure |
IDP-121 Lotion
n=413 Participants
IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
|
IDP-121 Vehicle Lotion
n=407 Participants
IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
|
|---|---|---|
|
Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12
|
-21.9 lesion count
Standard Deviation 22.70
|
-13.9 lesion count
Standard Deviation 23.30
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: ITT population included all randomized participants who received study drug. Multiple imputation (MCMC) was used to impute missing values.
Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.
Outcome measures
| Measure |
IDP-121 Lotion
n=413 Participants
IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
|
IDP-121 Vehicle Lotion
n=407 Participants
IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
|
|---|---|---|
|
Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12
|
-13.9 lesion count
Standard Deviation 11.99
|
-10.7 lesion count
Standard Deviation 12.12
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: ITT population included all randomized participants who received study drug and evaluable for EGSS score. Multiple imputation (MCMC) was used to impute missing values.
Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to "Clear" or "Almost Clear". EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Outcome measures
| Measure |
IDP-121 Lotion
n=413 Participants
IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
|
IDP-121 Vehicle Lotion
n=407 Participants
IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Treatment Success at Week 12
|
19.8 percentage of participants
|
12.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT population included all randomized participants who received study drug. Multiple imputation (MCMC) was used to impute missing values.
Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.
Outcome measures
| Measure |
IDP-121 Lotion
n=413 Participants
IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
|
IDP-121 Vehicle Lotion
n=407 Participants
IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Noninflammatory Lesion Count to Week 12
|
-45.6 percent change
Standard Deviation 44.64
|
-31.9 percent change
Standard Deviation 45.79
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT population included all randomized participants who received study drug. Multiple imputation (MCMC) was used to impute missing values.
Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.
Outcome measures
| Measure |
IDP-121 Lotion
n=413 Participants
IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
|
IDP-121 Vehicle Lotion
n=407 Participants
IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Inflammatory Lesion Count to Week 12
|
-53.4 percent change
Standard Deviation 45.44
|
-41.5 percent change
Standard Deviation 45.68
|
Adverse Events
IDP-121 Lotion
IDP-121 Vehicle Lotion
Serious adverse events
| Measure |
IDP-121 Lotion
n=389 participants at risk
IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
|
IDP-121 Vehicle Lotion
n=398 participants at risk
IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.98%
2/204 • Baseline (Day 0) up to Week 12
Safety population included all randomized participants who were presumed to have used study drug at least once and who provided at least 1 post baseline evaluation.
|
0.44%
1/229 • Baseline (Day 0) up to Week 12
Safety population included all randomized participants who were presumed to have used study drug at least once and who provided at least 1 post baseline evaluation.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/389 • Baseline (Day 0) up to Week 12
Safety population included all randomized participants who were presumed to have used study drug at least once and who provided at least 1 post baseline evaluation.
|
0.25%
1/398 • Baseline (Day 0) up to Week 12
Safety population included all randomized participants who were presumed to have used study drug at least once and who provided at least 1 post baseline evaluation.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/389 • Baseline (Day 0) up to Week 12
Safety population included all randomized participants who were presumed to have used study drug at least once and who provided at least 1 post baseline evaluation.
|
0.25%
1/398 • Baseline (Day 0) up to Week 12
Safety population included all randomized participants who were presumed to have used study drug at least once and who provided at least 1 post baseline evaluation.
|
Other adverse events
Adverse event data not reported
Additional Information
Clinical Operations Director
Bausch Health Americas, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee Please contact Sponsor directly for additional information.
- Publication restrictions are in place
Restriction type: OTHER