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Trial record 68 of 79 for:    acne AND almost AND facial

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

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ClinicalTrials.gov Identifier: NCT00687908
Recruitment Status : Completed
First Posted : June 2, 2008
Results First Posted : September 24, 2010
Last Update Posted : October 5, 2010
Sponsor:
Information provided by:
Galderma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne
Interventions Drug: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
Drug: Vehicle Gel
Enrollment 243
Recruitment Details 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  
Arm/Group Title Adapalene-BPO Vehicle
Hide Arm/Group Description Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Vehicle Gel
Period Title: Overall Study
Started 123 120
Completed 105 78
Not Completed 18 42
Arm/Group Title Adapalene-BPO Vehicle Total
Hide Arm/Group Description Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Vehicle Gel Total of all reporting groups
Overall Number of Baseline Participants 123 120 243
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 120 participants 243 participants
<=18 years
76
  61.8%
84
  70.0%
160
  65.8%
Between 18 and 65 years
47
  38.2%
36
  30.0%
83
  34.2%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 123 participants 120 participants 243 participants
19.1  (5.89) 18.2  (5.23) 18.6  (5.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 120 participants 243 participants
Female
58
  47.2%
53
  44.2%
111
  45.7%
Male
65
  52.8%
67
  55.8%
132
  54.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 123 participants 120 participants 243 participants
United States 84 79 163
Puerto Rico 13 13 26
Canada 26 28 54
1.Primary Outcome
Title Maintenance Success for Total Lesions at Week 24
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT - Worst-case (Any missing data at Week 24 is considered as a failure)
Arm/Group Title Adapalene-BPO Vehicle
Hide Arm/Group Description:
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
Vehicle Gel
Overall Number of Participants Analyzed 123 120
Measure Type: Number
Unit of Measure: percent of subjects
78.9 45.8
2.Secondary Outcome
Title Maintenance Success for Inflamatory Lesions at Week 24
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Adapalene-BPO Vehicle
Hide Arm/Group Description:
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
Vehicle Gel
Overall Number of Participants Analyzed 123 120
Measure Type: Number
Unit of Measure: percent of subjects
78 48.3
3.Secondary Outcome
Title Maintenance Success for Non-inflammatory Lesions at Week 24
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Adapalene-BPO Vehicle
Hide Arm/Group Description:
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
Vehicle Gel
Overall Number of Participants Analyzed 123 120
Measure Type: Number
Unit of Measure: percent of subjects
78 43.3
4.Secondary Outcome
Title Investigator Global Assessment (IGA) Maintenance Success at Week 24
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Adapalene-BPO Vehicle
Hide Arm/Group Description:
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
Vehicle Gel
Overall Number of Participants Analyzed 123 120
Measure Type: Number
Unit of Measure: percent of subjects
70.7 34.2
5.Secondary Outcome
Title Percent of Subjects With Adverse Events
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adapalene-BPO Vehicle
Hide Arm/Group Description:
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
Vehicle Gel
Overall Number of Participants Analyzed 123 120
Measure Type: Number
Unit of Measure: percent of subjects
41.5 29.2
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adapalene-BPO Vehicle
Hide Arm/Group Description Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Vehicle Gel
All-Cause Mortality
Adapalene-BPO Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Adapalene-BPO Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/123 (0.81%)      1/120 (0.83%)    
Infections and infestations     
Pilonidal abscess  1  0/123 (0.00%)  0 1/120 (0.83%)  1
Nervous system disorders     
Bipolar disorder  1  1/123 (0.81%)  1 0/120 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Adapalene-BPO Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   43/123 (34.96%)      27/120 (22.50%)    
Gastrointestinal disorders     
Nausea  1  3/123 (2.44%)  3 0/120 (0.00%)  0
General disorders     
Pyrexia  1  4/123 (3.25%)  4 1/120 (0.83%)  1
Infections and infestations     
Influenza  1  4/123 (3.25%)  4 1/120 (0.83%)  1
Nasopharyngitis  1  8/123 (6.50%)  10 12/120 (10.00%)  12
Pharyngitis  1  4/123 (3.25%)  4 1/120 (0.83%)  1
Pharyngitis streptococcal  1  4/123 (3.25%)  4 1/120 (0.83%)  1
Sinusitis  1  4/123 (3.25%)  4 2/120 (1.67%)  2
Upper respiratory tract infection  1  4/123 (3.25%)  5 4/120 (3.33%)  4
Nervous system disorders     
Headache  1  5/123 (4.07%)  5 3/120 (2.50%)  3
Respiratory, thoracic and mediastinal disorders     
Pharyngolaryngeal pain  1  3/123 (2.44%)  3 2/120 (1.67%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
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.
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
Layout table for Results Point of Contact information
Name/Title: Clinical Project Manager
Organization: Galderma
Phone: +33 492 95 29 21
EMail: jean-charles.dhuin@galderma.com
Layout table for additonal information
Responsible Party: Jean-Charles DHUIN Clinical Trial Manager, Galderma
ClinicalTrials.gov Identifier: NCT00687908     History of Changes
Other Study ID Numbers: RD.03.SPR.29075
First Submitted: May 28, 2008
First Posted: June 2, 2008
Results First Submitted: July 16, 2010
Results First Posted: September 24, 2010
Last Update Posted: October 5, 2010