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 |
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Recruitment Status :
Completed
First Posted : April 17, 2009
Results First Posted : December 8, 2010
Last Update Posted : February 18, 2021
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Sponsor:
Galderma R&D
Information provided by:
Galderma R&D
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment |
| Condition |
Acne |
| Interventions |
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 |
| Enrollment | 123 |
Participant Flow
| Recruitment Details | Recruitment period: 23 APR 2009 to 09 SEP 2009 in three private practice Canadian centres. Two centers used a central IRB, and the other used a local IRB. |
| Pre-assignment Details |
| Arm/Group Title | Adapalene-BPO Gel 3h | Adapalene-BPO Gel EoD | Adapalene-BPO Gel Cetaphil | Adapalene-BPO Gel StD |
|---|---|---|---|---|
 Arm/Group Description |
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 | 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 | 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 | Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week |
| Period Title: Overall Study | ||||
| Started | 32 | 32 | 29 | 30 |
| Completed | 27 | 28 | 25 | 25 |
| Not Completed | 5 | 4 | 4 | 5 |
Baseline Characteristics
| Arm/Group Title | Adapalene-BPO Gel 3h | Adapalene-BPO Gel EoD | Adapalene-BPO Gel Cetaphil | Adapalene-BPO Gel StD | Total | |
|---|---|---|---|---|---|---|
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Arm/Group Description |
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 | 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 | 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 | Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week | Total of all reporting groups | |
| Overall Number of Baseline Participants | 32 | 32 | 29 | 30 | 123 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 32 participants | 32 participants | 29 participants | 30 participants | 123 participants | |
| <=18 years |
15 46.9%
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15 46.9%
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13 44.8%
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14 46.7%
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57 46.3%
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| Between 18 and 65 years |
17 53.1%
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17 53.1%
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16 55.2%
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16 53.3%
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66 53.7%
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| >=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 32 participants | 32 participants | 29 participants | 30 participants | 123 participants | |
| 20.2 (6.5) | 20.4 (6.39) | 20.9 (6.83) | 20.8 (6.31) | 20.6 (6.43) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 32 participants | 32 participants | 29 participants | 30 participants | 123 participants | |
| Female |
20 62.5%
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19 59.4%
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16 55.2%
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16 53.3%
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71 57.7%
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| Male |
12 37.5%
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13 40.6%
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13 44.8%
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14 46.7%
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52 42.3%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| Canada | Number Analyzed | 32 participants | 32 participants | 29 participants | 30 participants | 123 participants |
| 32 | 32 | 29 | 30 | 123 | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Any intent of the investigator to publish or disclose in any way the information requires the sponsor's prior written approval. The investigator shall provide their draft of such publication to sponsor for review and approval at least 2 months prior to the date of the intended publication. Sponsor shall have the absolute right to determine whether information may be published by the investigator.
Results Point of Contact
| Name/Title: | Jean-Charles Dhuin |
| Organization: | Galderma |
| Phone: | +33492952921 |
| EMail: | jean-charles.dhuin@galderma.com |
| Responsible Party: | Jean-Charles DHUIN Clinical Trial Manager, Galderma |
| ClinicalTrials.gov Identifier: | NCT00883233 |
| Other Study ID Numbers: |
RD.03.SPR.29085 |
| First Submitted: | April 16, 2009 |
| First Posted: | April 17, 2009 |
| Results First Submitted: | October 11, 2010 |
| Results First Posted: | December 8, 2010 |
| Last Update Posted: | February 18, 2021 |