Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 21 of 134 for:    acne AND peroxide

Anti Propionibacterium(P.) Acnes Activity of Epiduo® Gel Compared to Benzoyl Peroxide (BPO) 2.5% Gel

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: NCT01188538
Recruitment Status : Completed
First Posted : August 25, 2010
Results First Posted : July 7, 2011
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Galderma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Epiduo gel
Drug: BPO
Enrollment 40
Recruitment Details 40 patients have been enrolled in one site in Poland: First subject included: March 3, 2010; last subject out: August 23, 2010
Pre-assignment Details  
Arm/Group Title Epiduo Gel Benzoyl Peroxide (BPO) Gel
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 20 20
Completed 20 19
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title Epiduo Gel Benzoyl Peroxide (BPO) Gel Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
<=18 years
3
  15.0%
4
  20.0%
7
  17.5%
Between 18 and 65 years
17
  85.0%
16
  80.0%
33
  82.5%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
22.9  (4.5) 21.4  (2.9) 22.1  (3.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
18
  90.0%
16
  80.0%
34
  85.0%
Male
2
  10.0%
4
  20.0%
6
  15.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Poland Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes
Hide Description

Quantitative bacterial examinations were performed on the subjects’ face during the study. These samplings were performed using a method to quantify the follicular microbiological flora of the skin (at Baseline and Week 12 visits).This method consists of a technique allowing the extraction of the outermost layer of epidermis from hair follicle on the cheek and to culture the samplings in order to have the number of P. acnes.

Outcome measure = Change from baseline (Log10 cfu/cm²) in count of Follicular P. acnes at end of the study.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent To Treat (ITT)/Last Observation Carried Forward (LOCF)
Arm/Group Title Epiduo Gel Benzoyl Peroxide (BPO) Gel
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: Log10 cfu/cm²
-1.94  (1.69) -1.56  (1.25)
2.Secondary Outcome
Title Percent Change (%) in Inflammatory Lesion Counts
Hide Description Inflammatory lesions were counted and recorded by the Evaluator (Investigator or designee) at Baseline and at Week 12. Based on these counts at Baseline and Week 12, Percent change (%) from Baseline in inflammatory lesion counts at Week 12 was calculated.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (LOCF)
Arm/Group Title Epiduo® Gel BPO Gel
Hide Arm/Group Description:
Epiduo® Gel Topical to the face, once daily application in the evening
BPO Gel Topical to the face, once daily application in the evening
Overall Number of Participants Analyzed 20 20
Median (Full Range)
Unit of Measure: Percent change (%)
-62.8
(-93.3 to 11.1)
-68.1
(-100 to 11.1)
Time Frame During the study (from baseline to Week 12)
Adverse Event Reporting Description Questioning at each follow up visit
 
Arm/Group Title Epiduo Gel Benzoyl Peroxide (BPO) Gel
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Epiduo Gel Benzoyl Peroxide (BPO) Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Epiduo Gel Benzoyl Peroxide (BPO) Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.5%
Epiduo Gel Benzoyl Peroxide (BPO) Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      0/20 (0.00%)    
Infections and infestations     
Sinusitis  1  1/20 (5.00%)  1 0/20 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 12.0
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Farzaneh SIDOU
Organization: Galderma
Phone: 00 33 4 93 95 70 51
EMail: farzaneh.sidou@galderma.com
Layout table for additonal information
Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01188538     History of Changes
Other Study ID Numbers: RD.03.SPR.29084
First Submitted: August 24, 2010
First Posted: August 25, 2010
Results First Submitted: June 9, 2011
Results First Posted: July 7, 2011
Last Update Posted: April 14, 2016