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Trial record 23 of 134 for:    acne AND peroxide

Epiduo Pediatric Acne Study

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: NCT01138735
Recruitment Status : Completed
First Posted : June 7, 2010
Results First Posted : March 26, 2013
Last Update Posted : April 11, 2013
Sponsor:
Information provided by (Responsible Party):
Galderma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Acne
Interventions Drug: adapalene/benzoyl peroxide
Drug: Topical Gel Vehicle
Enrollment 285
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adapalene/Benzoyl Peroxide Topical Gel Vehicle
Hide Arm/Group Description Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks Topical Gel Vehicle applied topically once daily for 12 weeks
Period Title: Overall Study
Started 142 143
Completed 134 126
Not Completed 8 17
Arm/Group Title Adapalene/Benzoyl Peroxide Topical Gel Vehicle Total
Hide Arm/Group Description Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks Topical Gel Vehicle applied topically once daily for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 142 143 285
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 143 participants 285 participants
<=18 years
142
 100.0%
143
 100.0%
285
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 142 participants 143 participants 285 participants
10.3  (0.76) 10.4  (0.68) 10.4  (0.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 143 participants 285 participants
Female
109
  76.8%
108
  75.5%
217
  76.1%
Male
33
  23.2%
35
  24.5%
68
  23.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 142 participants 143 participants 285 participants
United States 130 129 259
Canada 12 14 26
1.Primary Outcome
Title Success Rate
Hide Description Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA)
Time Frame Baseline to Week 12 (Last Observation Carried Forward [LOCF])
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population, LOCF
Arm/Group Title Adapalene/Benzoyl Peroxide Topical Gel Vehicle
Hide Arm/Group Description:
Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
Topical Gel Vehicle applied topically once daily for 12 weeks
Overall Number of Participants Analyzed 142 143
Measure Type: Number
Unit of Measure: percentage of participant
47.2 15.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adapalene/Benzoyl Peroxide, Topical Gel Vehicle
Comments

null hypothesis: no difference in Success rate in two treatment groups (adapalene/benzoyl peroxide vs Topical Gel Vehicle).

power calculation: 90%

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustment for multiplicity is required. The tests will be conducted as two-sided, each at the 0.05 significance level. The trial will be claimed ‘positive’ if all primary analyses are shown statistically significant at the 0.05 level.
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel(CMH) test stratified by analysis center, using general association statistics
2.Primary Outcome
Title Change From Baseline in Total Lesion Counts
Hide Description [Not Specified]
Time Frame Baseline to Week 12 (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, LOCF
Arm/Group Title Adapalene/Benzoyl Peroxide Topical Gel Vehicle
Hide Arm/Group Description:
Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
Topical Gel Vehicle applied topically once daily for 12 weeks
Overall Number of Participants Analyzed 142 143
Mean (Standard Deviation)
Unit of Measure: lesion count change
-27.6  (22.43) -3.6  (24.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adapalene/Benzoyl Peroxide, Topical Gel Vehicle
Comments null hypothesis: no difference in change from baseline in total lesion count in two treatment groups (adapalene/benzoyl peroxide vs Topical Gel Vehicle)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustment for multiplicity is required. The tests will be conducted as two-sided, each at the 0.05 significance level. The trial will be claimed ‘positive’ if all primary analyses are shown statistically significant at the 0.05 level.
Method ANCOVA
Comments normality assumption is not met. ANCOVA Model: Ranked Change in Total Lesion Counts = Ranked Baseline Lesion Counts, Analysis Center, Treatment.
3.Secondary Outcome
Title Percent Change in Total Lesion Counts From Baseline
Hide Description [Not Specified]
Time Frame Baseline to Week 12 (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, LOCF
Arm/Group Title Adapalene/Benzoyl Peroxide Topical Gel Vehicle
Hide Arm/Group Description:
Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
Topical Gel Vehicle applied topically once daily for 12 weeks
Overall Number of Participants Analyzed 142 143
Mean (Standard Deviation)
Unit of Measure: percentage of change in lesion count
-55.5  (38.99) -9.3  (48.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adapalene/Benzoyl Peroxide, Topical Gel Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test with row mean difference statistic using relative to an identified distribution(RIDIT) score, controlling for analysis center
4.Secondary Outcome
Title Change in Inflammatory Lesion Counts From Baseline
Hide Description [Not Specified]
Time Frame Baseline to Week 12 (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, LOCF
Arm/Group Title Adapalene/Benzoyl Peroxide Topical Gel Vehicle
Hide Arm/Group Description:
Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
Topical Gel Vehicle applied topically once daily for 12 weeks
Overall Number of Participants Analyzed 142 143
Mean (Standard Deviation)
Unit of Measure: lesion count change
-7.4  (12.46) -0.7  (12.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adapalene/Benzoyl Peroxide, Topical Gel Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Ranked Change in Inflammatory Lesion Counts = Ranked Baseline Inflammatory Lesion Counts, Analysis Center, Treatment
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adapalene/Benzoyl Peroxide Topical Gel Vehicle
Hide Arm/Group Description Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks Topical Gel Vehicle applied topically once daily for 12 weeks
All-Cause Mortality
Adapalene/Benzoyl Peroxide Topical Gel Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Adapalene/Benzoyl Peroxide Topical Gel Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/142 (0.00%)      1/143 (0.70%)    
Congenital, familial and genetic disorders     
RIGHT FRONTAL ARTERIOVENOUS MALFORMATION * 1 [1]  0/142 (0.00%)  0 1/143 (0.70%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
[1]
occurred on Day 2, resolved on Day 29 and the subject completed the study as planned.Severe, nonrelated Adverse Events (AE), Inpatient hospitalization.
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 Topical Gel Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/142 (26.06%)      18/143 (12.59%)    
Infections and infestations     
Upper respiratory tract infection * 1  10/142 (7.04%)  5/143 (3.50%) 
Nasopharyngitis * 1  8/142 (5.63%)  13/143 (9.09%) 
Skin and subcutaneous tissue disorders     
Skin burning sensation * 1  14/142 (9.86%)  0/143 (0.00%) 
Skin irritation * 1  8/142 (5.63%)  0/143 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
LOCF data were used for primary efficacy and secondary efficacy data.
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.
 
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: Galderma
ClinicalTrials.gov Identifier: NCT01138735     History of Changes
Other Study ID Numbers: RD.06.SPR.18155
First Submitted: June 4, 2010
First Posted: June 7, 2010
Results First Submitted: February 19, 2013
Results First Posted: March 26, 2013
Last Update Posted: April 11, 2013