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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
Results First Received: October 11, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Adapalene-BPO Gel 3h 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-BPO Gel EoD 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-BPO Gel Cetaphil 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-BPO Gel StD Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week

Participant Flow:   Overall Study
    Adapalene-BPO Gel 3h   Adapalene-BPO Gel EoD   Adapalene-BPO Gel Cetaphil   Adapalene-BPO Gel StD
STARTED   32   32   29   30 
COMPLETED   27   28   25   25 
NOT COMPLETED   5   4   4   5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Adapalene-BPO Gel 3h 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-BPO Gel EoD 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-BPO Gel Cetaphil 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-BPO Gel StD Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
Total Total of all reporting groups

Baseline Measures
   Adapalene-BPO Gel 3h   Adapalene-BPO Gel EoD   Adapalene-BPO Gel Cetaphil   Adapalene-BPO Gel StD   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   32   29   30   123 
Age 
[Units: Participants]
         
<=18 years   15   15   13   14   57 
Between 18 and 65 years   17   17   16   16   66 
>=65 years   0   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 20.2  (6.5)   20.4  (6.39)   20.9  (6.83)   20.8  (6.31)   20.6  (6.43) 
Gender 
[Units: Participants]
         
Female   20   19   16   16   71 
Male   12   13   13   14   52 
Region of Enrollment 
[Units: Participants]
         
Canada   32   32   29   30   123 


  Outcome Measures

1.  Primary:   Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline.   [ Time Frame: Week 4 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Jean-Charles Dhuin
Organization: Galderma
phone: +33492952921
e-mail: jean-charles.dhuin@galderma.com



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