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

This study has been completed.
Sponsor:
Information provided by:
Galderma
ClinicalTrials.gov Identifier:
NCT00883233
First received: April 16, 2009
Last updated: November 11, 2010
Last verified: November 2010

April 16, 2009
November 11, 2010
April 2009
September 2009   (final data collection date for primary outcome measure)
Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline. [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
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.
Local tolerability will be analyzed in terms of worsening from Baseline with maximum severity reached. [ Time Frame: Baseline, W2, W4, W8, W12/Early termination ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00883233 on ClinicalTrials.gov Archive Site
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Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Acne
  • 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
  • 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
  • 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
  • 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
  • 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
    Intervention: Drug: Adapalene-BPO 3-hour daily application 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
    Intervention: Drug: Adapalene-BPO Gel every other day application
  • 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
    Intervention: Drug: Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion
  • Active Comparator: 4
    Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
    Intervention: Drug: Adapalene BPO Gel standard daily overnight application
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
September 2009
September 2009   (final data collection date for primary outcome measure)

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.)
Both
12 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00883233
RD.03.SPR.29085
No
Jean-Charles DHUIN Clinical Trial Manager, Galderma
Galderma
Not Provided
Principal Investigator: Jerry Tan, MD Windsor, ON, Canada
Galderma
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP