Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance (ACCESS II)

This study has been completed.
Sponsor:
Information provided by:
Galderma
ClinicalTrials.gov Identifier:
NCT00687908
First received: May 28, 2008
Last updated: September 30, 2010
Last verified: September 2010
Results First Received: July 16, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acne
Interventions: Drug: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
Drug: Vehicle Gel

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: 12 NOV 2008 to 09 FEB 2009 in thirty-four centers (29 in the USA and 5 in Canada) public or private practices. Twenty-four USA centers and four Candadian centers used a central IRB, and the others 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 Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
Vehicle Vehicle Gel

Participant Flow:   Overall Study
    Adapalene-BPO     Vehicle  
STARTED     123     120  
COMPLETED     105     78  
NOT COMPLETED     18     42  



  Baseline Characteristics
  Hide Baseline Characteristics

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 Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
Vehicle Vehicle Gel
Total Total of all reporting groups

Baseline Measures
    Adapalene-BPO     Vehicle     Total  
Number of Participants  
[units: participants]
  123     120     243  
Age  
[units: participants]
     
<=18 years     76     84     160  
Between 18 and 65 years     47     36     83  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  19.1  ± 5.89     18.2  ± 5.23     18.6  ± 5.58  
Gender  
[units: participants]
     
Female     58     53     111  
Male     65     67     132  
Region of Enrollment  
[units: participants]
     
United States     84     79     163  
Puerto Rico     13     13     26  
Canada     26     28     54  



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Maintenance Success for Total Lesions at Week 24   [ Time Frame: Week 24 ]

Measure Type Primary
Measure Title Maintenance Success for Total Lesions at Week 24
Measure Description Maintenance success for total lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of total lesion counts.
Time Frame Week 24  
Safety Issue No  

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.
ITT - Worst-case (Any missing data at Week 24 is considered as a failure)

Reporting Groups
  Description
Adapalene-BPO Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
Vehicle Vehicle Gel

Measured Values
    Adapalene-BPO     Vehicle  
Number of Participants Analyzed  
[units: participants]
  123     120  
Maintenance Success for Total Lesions at Week 24  
[units: percent of subjects]
  78.9     45.8  

No statistical analysis provided for Maintenance Success for Total Lesions at Week 24



2.  Secondary:   Maintenance Success for Inflamatory Lesions at Week 24   [ Time Frame: Week 24 ]

Measure Type Secondary
Measure Title Maintenance Success for Inflamatory Lesions at Week 24
Measure Description Maintenance success for inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of inflamatory lesion counts.
Time Frame Week 24  
Safety Issue No  

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.
ITT - Worst-case (Any missing data at each visit is considered as a failure, except where maintenance rate of both previous and following visits are success)

Reporting Groups
  Description
Adapalene-BPO Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
Vehicle Vehicle Gel

Measured Values
    Adapalene-BPO     Vehicle  
Number of Participants Analyzed  
[units: participants]
  123     120  
Maintenance Success for Inflamatory Lesions at Week 24  
[units: percent of subjects]
  78     48.3  

No statistical analysis provided for Maintenance Success for Inflamatory Lesions at Week 24



3.  Secondary:   Maintenance Success for Non-inflammatory Lesions at Week 24   [ Time Frame: Week 24 ]

Measure Type Secondary
Measure Title Maintenance Success for Non-inflammatory Lesions at Week 24
Measure Description Maintenance success for non-inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of non-inflamatory lesion counts.
Time Frame Week 24  
Safety Issue No  

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.
ITT - Worst-case (Any missing data at each visit is considered as a failure, except where maintenance rate of both previous and following visits are success)

Reporting Groups
  Description
Adapalene-BPO Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
Vehicle Vehicle Gel

Measured Values
    Adapalene-BPO     Vehicle  
Number of Participants Analyzed  
[units: participants]
  123     120  
Maintenance Success for Non-inflammatory Lesions at Week 24  
[units: percent of subjects]
  78     43.3  

No statistical analysis provided for Maintenance Success for Non-inflammatory Lesions at Week 24



4.  Secondary:   Investigator Global Assessment (IGA) Maintenance Success at Week 24   [ Time Frame: Baseline, Week 24 ]

Measure Type Secondary
Measure Title Investigator Global Assessment (IGA) Maintenance Success at Week 24
Measure Description

IGA maintenance success is defined as the percentage of subjects with IGA grade inferior or equal to Baseline IGA grade.

IGA grade:

0 Clear:Residual hyperpigmentation & erythema may be present

  1. Almost Clear:A few scattered comedones & a few small papules.
  2. Mild:Some comedones & some papules and pustules. No nodules present
  3. Moderate:Many comedones, papules & pustules. One nodule may be present
  4. Severe:Covered with comedones, numerous papules & pustules & few nodules & cysts may be present
  5. Very severe:Highly inflammatory acne covering the face; with nodules & cysts present
Time Frame Baseline, Week 24  
Safety Issue No  

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.
ITT - Worst-case (Any missing data at each visit is considered as a failure, except where maintenance rate of both previous and following visits are success)

Reporting Groups
  Description
Adapalene-BPO Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
Vehicle Vehicle Gel

Measured Values
    Adapalene-BPO     Vehicle  
Number of Participants Analyzed  
[units: participants]
  123     120  
Investigator Global Assessment (IGA) Maintenance Success at Week 24  
[units: percent of subjects]
  70.7     34.2  

No statistical analysis provided for Investigator Global Assessment (IGA) Maintenance Success at Week 24



5.  Secondary:   Percent of Subjects With Adverse Events   [ Time Frame: Up to 24 weeks ]

Measure Type Secondary
Measure Title Percent of Subjects With Adverse Events
Measure Description All participants with events were measured for that particular Outcome Measure and not only the events with a frequency threshold above 2 percent
Time Frame Up to 24 weeks  
Safety Issue Yes  

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 Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
Vehicle Vehicle Gel

Measured Values
    Adapalene-BPO     Vehicle  
Number of Participants Analyzed  
[units: participants]
  123     120  
Percent of Subjects With Adverse Events  
[units: percent of subjects]
  41.5     29.2  

No statistical analysis provided for Percent of Subjects With Adverse Events




  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Clinical Project Manager
Organization: Galderma
phone: +33 492 95 29 21
e-mail: jean-charles.dhuin@galderma.com


No publications provided


Responsible Party: Jean-Charles DHUIN Clinical Trial Manager, Galderma
ClinicalTrials.gov Identifier: NCT00687908     History of Changes
Other Study ID Numbers: RD.03.SPR.29075
Study First Received: May 28, 2008
Results First Received: July 16, 2010
Last Updated: September 30, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada
Canada: Ethics Review Committee