Trial Outcomes & Findings for Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris (NCT NCT02932306)
NCT ID: NCT02932306
Last Updated: 2020-01-03
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
820 participants
Primary outcome timeframe
Baseline (Day 0), Week 12
Results posted on
2020-01-03
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
|
406
|
414
|
|
Overall Study
Intent-to-treat (ITT) Population
|
406
|
414
|
|
Overall Study
Safety Population
|
378
|
385
|
|
Overall Study
COMPLETED
|
338
|
337
|
|
Overall Study
NOT COMPLETED
|
68
|
77
|
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
Withdrawal by Subject
|
16
|
25
|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Pregnancy
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Noncompliance with Study Drug
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
36
|
40
|
|
Overall Study
Withdrawal by Parent or Guardian
|
6
|
8
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Worsening condition
|
2
|
0
|
|
Overall Study
Withdrew due to burning,itching,stinging
|
1
|
0
|
Baseline Characteristics
'Number analyzed' signifies participants evaluable for this parameter.
Baseline characteristics by cohort
| Measure |
IDP-121 Lotion
n=406 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=414 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
|
20.3 years
STANDARD_DEVIATION 7.15 • n=406 Participants
|
20.5 years
STANDARD_DEVIATION 7.26 • n=414 Participants
|
20.4 years
STANDARD_DEVIATION 7.20 • n=820 Participants
|
|
Sex: Female, Male
Female
|
229 Participants
n=406 Participants
|
247 Participants
n=414 Participants
|
476 Participants
n=820 Participants
|
|
Sex: Female, Male
Male
|
177 Participants
n=406 Participants
|
167 Participants
n=414 Participants
|
344 Participants
n=820 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
146 Participants
n=406 Participants
|
168 Participants
n=414 Participants
|
314 Participants
n=820 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
260 Participants
n=406 Participants
|
246 Participants
n=414 Participants
|
506 Participants
n=820 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=406 Participants
|
0 Participants
n=414 Participants
|
0 Participants
n=820 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=406 Participants
|
1 Participants
n=414 Participants
|
5 Participants
n=820 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=406 Participants
|
20 Participants
n=414 Participants
|
40 Participants
n=820 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=406 Participants
|
5 Participants
n=414 Participants
|
8 Participants
n=820 Participants
|
|
Race (NIH/OMB)
Black or African American
|
75 Participants
n=406 Participants
|
72 Participants
n=414 Participants
|
147 Participants
n=820 Participants
|
|
Race (NIH/OMB)
White
|
296 Participants
n=406 Participants
|
308 Participants
n=414 Participants
|
604 Participants
n=820 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=406 Participants
|
8 Participants
n=414 Participants
|
16 Participants
n=820 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=406 Participants
|
0 Participants
n=414 Participants
|
0 Participants
n=820 Participants
|
|
Evaluator's Global Severity Score (EGSS)
0 - Clear
|
0 Participants
n=405 Participants • 'Number analyzed' signifies participants evaluable for this parameter.
|
0 Participants
n=414 Participants • 'Number analyzed' signifies participants evaluable for this parameter.
|
0 Participants
n=819 Participants • 'Number analyzed' signifies participants evaluable for this parameter.
|
|
Evaluator's Global Severity Score (EGSS)
1 - Almost Clear
|
0 Participants
n=405 Participants • 'Number analyzed' signifies participants evaluable for this parameter.
|
0 Participants
n=414 Participants • 'Number analyzed' signifies participants evaluable for this parameter.
|
0 Participants
n=819 Participants • 'Number analyzed' signifies participants evaluable for this parameter.
|
|
Evaluator's Global Severity Score (EGSS)
2 - Mild
|
0 Participants
n=405 Participants • 'Number analyzed' signifies participants evaluable for this parameter.
|
0 Participants
n=414 Participants • 'Number analyzed' signifies participants evaluable for this parameter.
|
0 Participants
n=819 Participants • 'Number analyzed' signifies participants evaluable for this parameter.
|
|
Evaluator's Global Severity Score (EGSS)
3 - Moderate
|
368 Participants
n=405 Participants • 'Number analyzed' signifies participants evaluable for this parameter.
|
366 Participants
n=414 Participants • 'Number analyzed' signifies participants evaluable for this parameter.
|
734 Participants
n=819 Participants • 'Number analyzed' signifies participants evaluable for this parameter.
|
|
Evaluator's Global Severity Score (EGSS)
4 - Severe
|
37 Participants
n=405 Participants • 'Number analyzed' signifies participants evaluable for this parameter.
|
48 Participants
n=414 Participants • 'Number analyzed' signifies participants evaluable for this parameter.
|
85 Participants
n=819 Participants • 'Number analyzed' signifies participants evaluable for this parameter.
|
|
Noninflammatory Lesion Count
|
38.0 lesion count
STANDARD_DEVIATION 15.67 • n=406 Participants
|
39.2 lesion count
STANDARD_DEVIATION 16.70 • n=414 Participants
|
38.6 lesion count
STANDARD_DEVIATION 16.20 • n=820 Participants
|
|
Inflammatory Lesion Count
|
26.1 lesion count
STANDARD_DEVIATION 5.56 • n=406 Participants
|
26.4 lesion count
STANDARD_DEVIATION 5.63 • n=414 Participants
|
26.3 lesion count
STANDARD_DEVIATION 5.60 • n=820 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=406 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=414 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
|
-17.8 lesion count
Standard Deviation 15.18
|
-10.6 lesion count
Standard Deviation 16.07
|
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=406 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=414 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
|
-13.1 lesion count
Standard Deviation 10.50
|
-10.2 lesion count
Standard Deviation 10.87
|
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. 1 participant was excluded from analysis of dichotomized EGSS because EGSS was not performed at baseline.
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=405 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=414 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
|
16.5 percentage of participants
|
6.9 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=406 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=414 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
|
-47.5 percent change
Standard Deviation 41.92
|
-27.3 percent change
Standard Deviation 43.96
|
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=406 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=414 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
|
-50.9 percent change
Standard Deviation 40.72
|
-40.4 percent change
Standard Deviation 42.29
|
Adverse Events
IDP-121 Lotion
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
IDP-121 Vehicle Lotion
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDP-121 Lotion
n=378 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=385 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
|
0.87%
2/229 • 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.
|
0.40%
1/247 • 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.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.00%
0/229 • 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.
|
0.40%
1/247 • 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.
|
|
Infections and infestations
Appendicitis
|
0.26%
1/378 • 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.
|
0.00%
0/385 • 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.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.26%
1/378 • 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.
|
0.00%
0/385 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.26%
1/378 • 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.
|
0.00%
0/385 • 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
Alcoholic pancreatitis
|
0.00%
0/378 • 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.
|
0.26%
1/385 • 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.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/378 • 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.
|
0.26%
1/385 • 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.
Phone: 1-510-259-5284
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Please contact Sponsor directly for additional information.
- Publication restrictions are in place
Restriction type: OTHER