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

NCT00883233 | Completed Phase 3 Results

• 1 other identifier: RD.03.SPR.29085
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Acne

Keywords

Acne

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

1

EXPERIMENTAL

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

2

EXPERIMENTAL

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

3

EXPERIMENTAL

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

4

ACTIVE COMPARATOR

Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week

Drug: Adapalene BPO Gel standard daily overnight application

Interventions

Adapalene BPO Gel standard daily overnight application DRUG

Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week

Also known as: Standard

4

Adapalene-BPO 3-hour daily application before bedtime DRUG

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

Also known as: 3-hour before bedtime

1

Adapalene-BPO Gel every other day application DRUG

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

Also known as: every other day

2

Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion DRUG

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

Also known as: Adapalene-BPO Gel with Cetaphil® Moisturizing Lotion

3

Eligibility Criteria

• Age: 12 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Subjects with more than 1 nodules or cysts on the face,
• Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (2)

Galderma Investigational Site

Windsor, Ontario, Canada

Location

Galderma Investigational Site

Montreal, Quebec, Canada

Location

Related Links

• Related Info

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Jean-Charles Dhuin
• Organization: Galderma

jean-charles.dhuin@galderma.com

+33492952921

Study Officials

• Jerry Tan, MD

  Windsor, ON, Canada

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 16, 2009
• First Posted: April 17, 2009
• Study Start: April 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: February 18, 2021
• Results First Posted: December 8, 2010

Record last verified: 2010-11

Locations

CA (2)