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Trial record 25 of 134 for:    acne AND peroxide

A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00421993
Recruitment Status : Completed
First Posted : January 15, 2007
Results First Posted : March 11, 2009
Last Update Posted : October 20, 2009
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 Vulgaris
Interventions Drug: Adapalene/Benzoyl Peroxide
Drug: Adapalene
Drug: Benzoyl Peroxide
Drug: Topical Gel Vehicle
Enrollment 1670
Recruitment Details

Recruitment period: First Subject Enrolled October 2006, Last Subject Enrolled July 2007.

Types of locations: Dermatology Clinics, Dermatology Research Centers.

Pre-assignment Details The specified washout period up to Baseline for TOPICAL facial treatments was 1 week (light therapy/exfoliation/blackhead removal) or 2 weeks (anti-inflammatory drugs/salicylic acid/steroids/antibiotics/laser) and for SYSTEMIC medications was 2 weeks (anti-inflammatory drugs), 4 Weeks (steroids/antibiotics), or 6 months (anti-acne/contraceptives).
Arm/Group Title Adapalene/Benzoyl Peroxide Gel Adapalene Gel Benzoyl Peroxide Gel Gel Vehicle
Hide Arm/Group Description Adapalene/Benzoyl Peroxide Topical Gel Adapalene Topical Gel Benzoyl Peroxide Topical Gel Topical Gel Vehicle
Period Title: Overall Study
Started 419 418 415 418
Completed 366 369 363 361
Not Completed 53 49 52 57
Reason Not Completed
Withdrawal by Subject             22             23             23             24
Lost to Follow-up             18             19             22             20
Adverse Event             11             1             6             4
Protocol Violation             2             2             0             1
Lack of Efficacy             0             3             0             5
Pregnancy             0             1             1             2
Subject transportation issues             0             0             0             1
Arm/Group Title Adapalene/Benzoyl Peroxide Gel Adapalene Gel Benzoyl Peroxide Gel Gel Vehicle Total
Hide Arm/Group Description Adapalene/Benzoyl Peroxide Topical Gel Adapalene Topical Gel Benzoyl Peroxide Topical Gel Topical Gel Vehicle Total of all reporting groups
Overall Number of Baseline Participants 419 418 415 418 1670
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 419 participants 418 participants 415 participants 418 participants 1670 participants
19.5  (6.7) 18.5  (6.3) 18.9  (6.96) 19.2  (7.23) 19  (6.81)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 419 participants 418 participants 415 participants 418 participants 1670 participants
12-17 years 233 241 244 243 961
Between 18 and 64 years 186 177 171 175 709
>=65 years 0 0 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 419 participants 418 participants 415 participants 418 participants 1670 participants
Female
236
  56.3%
229
  54.8%
230
  55.4%
244
  58.4%
939
  56.2%
Male
183
  43.7%
189
  45.2%
185
  44.6%
174
  41.6%
731
  43.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 419 participants 418 participants 415 participants 418 participants 1670 participants
United States 185 185 179 185 734
Canada 102 100 100 101 403
Europe 132 133 136 132 533
1.Primary Outcome
Title Success Rate on the Investigator's Global Assessment
Hide Description Percentage of subjects rated “Clear” and “Almost Clear” on 5-point scale (0=clear; 4=severe)
Time Frame at week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT), last observation carried forward (LOCF).
Arm/Group Title Adapalene/Benzoyl Peroxide Gel Adapalene Gel Benzoyl Peroxide Gel Gel Vehicle
Hide Arm/Group Description:
Adapalene/Benzoyl Peroxide Topical Gel
Adapalene Topical Gel
Benzoyl Peroxide Topical Gel
Topical Gel Vehicle
Overall Number of Participants Analyzed 419 418 415 418
Measure Type: Number
Unit of Measure: Percentage of participants
37.9 21.8 26.7 17.9
2.Primary Outcome
Title Changes in Inflammatory Lesion Counts
Hide Description Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts
Time Frame from Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Adapalene/Benzoyl Peroxide Gel Adapalene Gel Benzoyl Peroxide Gel Gel Vehicle
Hide Arm/Group Description:
Adapalene/Benzoyl Peroxide Topical Gel
Adapalene Topical Gel
Benzoyl Peroxide Topical Gel
Topical Gel Vehicle
Overall Number of Participants Analyzed 419 418 415 418
Median (Full Range)
Unit of Measure: Lesion count
-18
(-49 to 50)
-15
(-49 to 50)
-16
(-63 to 38)
-12
(-47 to 95)
3.Primary Outcome
Title Changes in Noninflammatory Lesion Counts
Hide Description Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count
Time Frame from Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Adapalene/Benzoyl Peroxide Gel Adapalene Gel Benzoyl Peroxide Gel Gel Vehicle
Hide Arm/Group Description:
Adapalene/Benzoyl Peroxide Topical Gel
Adapalene Topical Gel
Benzoyl Peroxide Topical Gel
Topical Gel Vehicle
Overall Number of Participants Analyzed 419 418 415 418
Median (Full Range)
Unit of Measure: Lesion count
-28
(-93 to 108)
-24
(-96 to 44)
-23
(-87 to 61)
-18
(-82 to 69)
4.Secondary Outcome
Title Percent Change in Inflammatory Lesion Counts
Hide Description Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Time Frame at week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Adapalene/Benzoyl Peroxide Gel Adapalene Gel Benzoyl Peroxide Gel Gel Vehicle
Hide Arm/Group Description:
Adapalene/Benzoyl Peroxide Topical Gel
Adapalene Topical Gel
Benzoyl Peroxide Topical Gel
Topical Gel Vehicle
Overall Number of Participants Analyzed 419 418 415 418
Mean (Standard Deviation)
Unit of Measure: Percent change
-61.7  (33.9) -50.1  (39.4) -52.2  (39.4) -40.8  (41.1)
5.Secondary Outcome
Title Percent Change in Noniflammatory Lesion Counts
Hide Description Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Time Frame at week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Adapalene/Benzoyl Peroxide Gel Adapalene Gel Benzoyl Peroxide Gel Gel Vehicle
Hide Arm/Group Description:
Adapalene/Benzoyl Peroxide Topical Gel
Adapalene Topical Gel
Benzoyl Peroxide Topical Gel
Topical Gel Vehicle
Overall Number of Participants Analyzed 419 418 415 418
Mean (Standard Deviation)
Unit of Measure: Percent change
-55.6  (35.3) -46.0  (33.7) -44.1  (37.3) -32.3  (39.5)
6.Secondary Outcome
Title Percent Change in Total Lesion Counts
Hide Description Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Time Frame at week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Adapalene/Benzoyl Peroxide Gel Adapalene Gel Benzoyl Peroxide Gel Gel Vehicle
Hide Arm/Group Description:
Adapalene/Benzoyl Peroxide Topical Gel
Adapalene Topical Gel
Benzoyl Peroxide Topical Gel
Topical Gel Vehicle
Overall Number of Participants Analyzed 419 418 415 418
Mean (Standard Deviation)
Unit of Measure: Percent change
-57.7  (31.9) -47.5  (31.3) -47.2  (32.7) -35.2  (36)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adapalene/Benzoyl Peroxide Gel Adapalene Gel Benzoyl Peroxide Gel Gel Vehicle
Hide Arm/Group Description Adapalene/Benzoyl Peroxide Topical Gel Adapalene Topical Gel Benzoyl Peroxide Topical Gel Topical Gel Vehicle
All-Cause Mortality
Adapalene/Benzoyl Peroxide Gel Adapalene Gel Benzoyl Peroxide Gel Gel Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Adapalene/Benzoyl Peroxide Gel Adapalene Gel Benzoyl Peroxide Gel Gel Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/419 (0.72%)      1/418 (0.24%)      1/415 (0.24%)      2/418 (0.48%)    
Infections and infestations         
Furuncle  1/419 (0.24%)  1 0/418 (0.00%)  0 0/415 (0.00%)  0 0/418 (0.00%)  0
Appendicitis  1/419 (0.24%)  1 0/418 (0.00%)  0 0/415 (0.00%)  0 0/418 (0.00%)  0
Abscess limb  0/419 (0.00%)  0 0/418 (0.00%)  0 0/415 (0.00%)  0 1/418 (0.24%)  1
Injury, poisoning and procedural complications         
Cervical vertebral fracture  0/419 (0.00%)  0 0/418 (0.00%)  0 0/415 (0.00%)  0 1/418 (0.24%)  1
Musculoskeletal and connective tissue disorders         
Scoliosis  1/419 (0.24%)  1 0/418 (0.00%)  0 0/415 (0.00%)  0 0/418 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous  0/419 (0.00%)  0 0/418 (0.00%)  0 1/415 (0.24%)  1 0/418 (0.00%)  0
Psychiatric disorders         
Schizoaffective disorder  0/419 (0.00%)  0 1/418 (0.24%)  1 0/415 (0.00%)  0 0/418 (0.00%)  0
1
Term from vocabulary, MedDRA (6.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Adapalene/Benzoyl Peroxide Gel Adapalene Gel Benzoyl Peroxide Gel Gel Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   90/419 (21.48%)      60/418 (14.35%)      35/415 (8.43%)      22/418 (5.26%)    
Skin and subcutaneous tissue disorders         
Dry Skin  90/419 (21.48%)  93 60/418 (14.35%)  61 35/415 (8.43%)  37 22/418 (5.26%)  22
1
Term from vocabulary, MedDRA (6.1)
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.
Following the expiration of twenty-four (24) months after the completion of the Study, Investigator shall have the right to publish the results of the Study; provided, however that Sponsor shall have the right to review any proposed publication generated from the Study prior to publication or presentation. The Sponsor shall have the absolute right to refuse the publication altogether, to delay it or to amend its contents as it deems fit.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Graeber, MD
Organization: Galderma
Phone: 609-860-8201
EMail: michael.graeber@galderma.com
Layout table for additonal information
Responsible Party: Michael Graeber, MD, Head of US Development, Galderma
ClinicalTrials.gov Identifier: NCT00421993     History of Changes
Other Study ID Numbers: RD.06.SPR.18088
First Submitted: January 11, 2007
First Posted: January 15, 2007
Results First Submitted: January 15, 2009
Results First Posted: March 11, 2009
Last Update Posted: October 20, 2009