Anti Propionibacterium(P.) Acnes Activity of Epiduo® Gel Compared to Benzoyl Peroxide (BPO) 2.5% Gel
Anti P. Acnes Activity of Epiduo® Gel Compared to Benzoyl Peroxide (BPO) 2.5% Gel in the Treatment of Subjects With Acne Vulgaris
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to evaluate the antibacterial activity of Epiduo® Gel (Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel) on P. acnes compared to that of Benzoyl Peroxide 2.5% Gel.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 24, 2010
CompletedFirst Posted
Study publicly available on registry
August 25, 2010
CompletedResults Posted
Study results publicly available
July 7, 2011
CompletedFebruary 18, 2021
July 1, 2011
5 months
August 24, 2010
June 9, 2011
February 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes
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.
Week 12
Secondary Outcomes (1)
Percent Change (%) in Inflammatory Lesion Counts
Week 12
Study Arms (2)
Epiduo gel
EXPERIMENTAL* Dose or Concentration:Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel. * Mode and Frequency of Administration:Topical to the face, once daily application in the evening. * Duration of Treatment:12 weeks
BPO gel
ACTIVE COMPARATOR* Dose or Concentration:Adapalene 0% / Benzoyl Peroxide 2.5% Gel. * Mode and Frequency of Administration:Topical to the face, once daily application in the evening. * Duration of Treatment:12 weeks
Interventions
Once daily application on the face in the evening for 12 weeks
Eligibility Criteria
You may qualify if:
- Subjects with facial acne,
- Subjects with high levels of P. acnes counts on the forehead
You may not qualify if:
- Female Subjects who are pregnant, nursing or planning a pregnancy during the study,
- Subjects with acne conglobata, acne fulminans, secondary acne
- Subjects with known or suspected allergy to one of the test product
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (1)
Dermatologiczna Klinika Uzdrowiskowa
Iwonicz-Zdrój, 38-440, Poland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Farzaneh SIDOU
- Organization
- Galderma
Study Officials
- PRINCIPAL INVESTIGATOR
Andrzej LANGNER, Professor
Dermatologiczna Klinika Uzdrowiskowa, IWOLANG Sp. z o.o. , Zespół Naukowo-Kliniczny, IWONICZ ZDRÓJ - POLAND
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2010
First Posted
August 25, 2010
Study Start
March 1, 2010
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
February 18, 2021
Results First Posted
July 7, 2011
Record last verified: 2011-07