Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris (FREE)
This study has been completed.
Sponsor:
Galderma
Information provided by:
Galderma
ClinicalTrials.gov Identifier:
NCT00883233
First received: April 16, 2009
Last updated: November 11, 2010
Last verified: November 2010
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Purpose
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.
| Condition | Intervention | 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 |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (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 |
Resource links provided by NLM:
Further study details as provided by Galderma:
Primary Outcome Measures:
- 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.
| Enrollment: | 123 |
| Study Start Date: | April 2009 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 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
|
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
|
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
|
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
|
Eligibility| Ages Eligible for Study: | 12 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883233
Locations
| Canada, Ontario | |
| Galderma Investigational Site | |
| Windsor, Ontario, Canada | |
| Canada, Quebec | |
| Galderma Investigational Site | |
| Montreal, Quebec, Canada | |
Sponsors and Collaborators
Galderma
Investigators
| Principal Investigator: | Jerry Tan, MD | Windsor, ON, Canada |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jean-Charles DHUIN Clinical Trial Manager, Galderma |
| ClinicalTrials.gov Identifier: | NCT00883233 History of Changes |
| Other Study ID Numbers: | RD.03.SPR.29085 |
| Study First Received: | April 16, 2009 |
| Results First Received: | October 11, 2010 |
| Last Updated: | November 11, 2010 |
| Health Authority: | Canada: Health Canada Canada: Ethics Review Committee |
Keywords provided by Galderma:
|
Acne |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases Adapalene Benzoyl Peroxide Emollients Dermatologic Agents Therapeutic Uses |
Pharmacologic Actions 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 Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013