Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris (FREE)
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ClinicalTrials.gov Identifier: NCT00883233 |
Recruitment Status :
Completed
First Posted : April 17, 2009
Results First Posted : December 8, 2010
Last Update Posted : February 18, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acne | Drug: Adapalene BPO Gel standard daily overnight application Drug: Adapalene-BPO 3-hour daily application before bedtime Drug: Adapalene-BPO Gel every other day application Drug: Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 123 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | September 2009 |
Actual Study Completion Date : | September 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
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Drug: Adapalene-BPO 3-hour daily application before bedtime
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
Other Name: 3-hour before bedtime |
Experimental: 2
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
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Drug: Adapalene-BPO Gel every other day application
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
Other Name: every other day |
Experimental: 3
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
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Drug: Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
Other Name: Adapalene-BPO Gel with Cetaphil® Moisturizing Lotion |
Active Comparator: 4
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
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Drug: Adapalene BPO Gel standard daily overnight application
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
Other Name: Standard |
- Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline. [ Time Frame: Week 4 ]Total Sum Score (TSS) is the sum of the 4 local tolerability scores for dryness, erythema, scaling and stinging/burning evaluated at each visit [None=0, Mild=1, Moderate=2 and Severe=3]. In consequence, it ranges from 0 [better outcome] to 12 [worse outcome]and was calculated for each study visit.

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Ages Eligible for Study: | 12 Years to 35 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female Subjects of any race, aged 12 to 35 years inclusive
- Subjects with mild or moderate facial acne vulgaris
- Subjects with skin phototype I to IV
Exclusion Criteria:
- Subjects with more than 1 nodules or cysts on the face,
- Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883233
Canada, Ontario | |
Galderma Investigational Site | |
Windsor, Ontario, Canada | |
Canada, Quebec | |
Galderma Investigational Site | |
Montreal, Quebec, Canada |
Principal Investigator: | Jerry Tan, MD | Windsor, ON, Canada |
Responsible Party: | Jean-Charles DHUIN Clinical Trial Manager, Galderma |
ClinicalTrials.gov Identifier: | NCT00883233 |
Other Study ID Numbers: |
RD.03.SPR.29085 |
First Posted: | April 17, 2009 Key Record Dates |
Results First Posted: | December 8, 2010 |
Last Update Posted: | February 18, 2021 |
Last Verified: | November 2010 |
Acne |
Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases Adapalene Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Dermatologic Agents |