Trial Outcomes & Findings for Epiduo Pediatric Acne Study (NCT NCT01138735)

NCT ID: NCT01138735

Last Updated: 2021-02-18

Results Overview

Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 285 participants
• Primary outcome timeframe: Baseline to Week 12 (Last Observation Carried Forward [LOCF])
• Results posted on: 2021-02-18

Participant Flow

Participant milestones

Measure	Adapalene/Benzoyl Peroxide Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks	Topical Gel Vehicle Topical Gel Vehicle applied topically once daily for 12 weeks
Overall Study STARTED	142	143
Overall Study COMPLETED	134	126
Overall Study NOT COMPLETED	8	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Epiduo Pediatric Acne Study

Baseline characteristics by cohort

Measure	Adapalene/Benzoyl Peroxide n=142 Participants Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks	Topical Gel Vehicle n=143 Participants Topical Gel Vehicle applied topically once daily for 12 weeks	Total n=285 Participants Total of all reporting groups
Age, Categorical <=18 years	142 Participants n=5 Participants	143 Participants n=7 Participants	285 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	10.3 years STANDARD_DEVIATION 0.76 • n=5 Participants	10.4 years STANDARD_DEVIATION 0.68 • n=7 Participants	10.4 years STANDARD_DEVIATION 0.72 • n=5 Participants
Sex: Female, Male Female	109 Participants n=5 Participants	108 Participants n=7 Participants	217 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	35 Participants n=7 Participants	68 Participants n=5 Participants
Region of Enrollment United States	130 participants n=5 Participants	129 participants n=7 Participants	259 participants n=5 Participants
Region of Enrollment Canada	12 participants n=5 Participants	14 participants n=7 Participants	26 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12 (Last Observation Carried Forward [LOCF])

Population: Intent to treat (ITT) population, LOCF

Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA)

Outcome measures

Measure	Adapalene/Benzoyl Peroxide n=142 Participants Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks	Topical Gel Vehicle n=143 Participants Topical Gel Vehicle applied topically once daily for 12 weeks
Success Rate	47.2 percentage of participant	15.4 percentage of participant

PRIMARY outcome

Timeframe: Baseline to Week 12 (LOCF)

Population: ITT population, LOCF

Outcome measures

Measure	Adapalene/Benzoyl Peroxide n=142 Participants Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks	Topical Gel Vehicle n=143 Participants Topical Gel Vehicle applied topically once daily for 12 weeks
Change From Baseline in Total Lesion Counts	-27.6 lesion count change Standard Deviation 22.43	-3.6 lesion count change Standard Deviation 24.44

SECONDARY outcome

Timeframe: Baseline to Week 12 (LOCF)

Population: ITT Population, LOCF

Outcome measures

Measure	Adapalene/Benzoyl Peroxide n=142 Participants Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks	Topical Gel Vehicle n=143 Participants Topical Gel Vehicle applied topically once daily for 12 weeks
Percent Change in Total Lesion Counts From Baseline	-55.5 percentage of change in lesion count Standard Deviation 38.99	-9.3 percentage of change in lesion count Standard Deviation 48.00

SECONDARY outcome

Timeframe: Baseline to Week 12 (LOCF)

Population: ITT Population, LOCF

Outcome measures

Measure	Adapalene/Benzoyl Peroxide n=142 Participants Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks	Topical Gel Vehicle n=143 Participants Topical Gel Vehicle applied topically once daily for 12 weeks
Change in Inflammatory Lesion Counts From Baseline	-7.4 lesion count change Standard Deviation 12.46	-0.7 lesion count change Standard Deviation 12.46

Adverse Events

Adapalene/Benzoyl Peroxide

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Topical Gel Vehicle

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Adapalene/Benzoyl Peroxide n=142 participants at risk Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks	Topical Gel Vehicle n=143 participants at risk Topical Gel Vehicle applied topically once daily for 12 weeks
Congenital, familial and genetic disorders RIGHT FRONTAL ARTERIOVENOUS MALFORMATION	0.00% 0/142	0.70% 1/143 • Number of events 1

Other adverse events

Measure	Adapalene/Benzoyl Peroxide n=142 participants at risk Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks	Topical Gel Vehicle n=143 participants at risk Topical Gel Vehicle applied topically once daily for 12 weeks
Skin and subcutaneous tissue disorders Skin burning sensation	9.9% 14/142	0.00% 0/143
Skin and subcutaneous tissue disorders Skin irritation	5.6% 8/142	0.00% 0/143
Infections and infestations Upper respiratory tract infection	7.0% 10/142	3.5% 5/143
Infections and infestations Nasopharyngitis	5.6% 8/142	9.1% 13/143

Additional Information

Michael Graeber, MD

Galderma

Phone: 609-860-8201

Email: michael.graeber@galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER