Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris (FREE)

Efficacy and Safety Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris

The purpose of this study is to compare the tolerability of 3 treatment regimens containing Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel with that of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. The efficacy of the four treatment regimens will also be evaluated.

Study Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: 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; Drug: Adapalene BPO Gel standard daily overnight application

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Windsor, Ontario, Canada
      • Galderma Investigational Site
  • Quebec
    • Montreal, Quebec, Canada
      • Galderma Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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	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 Names: 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	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 Names: 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	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 Names: 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	Drug: Adapalene BPO Gel standard daily overnight application; Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week; Other Names: Standard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline.	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.	Week 4

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Principal Investigator: Jerry Tan, MD, Windsor, ON, Canada

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: April 16, 2009
• First Submitted That Met QC Criteria: April 16, 2009
• First Posted (Estimate): April 17, 2009

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Acne
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Adapalene
• Other Study ID Numbers: RD.03.SPR.29085