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Trial record 30 of 233 for:    acne AND Percent

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

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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

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Epiduo gel Drug: BPO Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Anti P. Acnes Activity of Epiduo® Gel Compared to Benzoyl Peroxide (BPO) 2.5% Gel in the Treatment of Subjects With Acne Vulgaris
Study Start Date : March 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Epiduo gel
  • 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
Drug: Epiduo gel
Once daily application on the face in the evening for 12 weeks
Other Name: Epiduo

Active Comparator: BPO gel
  • 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
Drug: BPO
Once daily application on the face in the evening for 12 weeks




Primary Outcome Measures :
  1. Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes [ Time Frame: Week 12 ]

    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.



Secondary Outcome Measures :
  1. Percent Change (%) in Inflammatory Lesion Counts [ Time Frame: Week 12 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with facial acne,
  • Subjects with high levels of P. acnes counts on the forehead

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188538


Locations
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Poland
Dermatologiczna Klinika Uzdrowiskowa
Iwonicz Zdrój, Poland, 38-440
Sponsors and Collaborators
Galderma
Investigators
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Principal Investigator: Andrzej LANGNER, Professor Dermatologiczna Klinika Uzdrowiskowa, IWOLANG Sp. z o.o. , Zespół Naukowo-Kliniczny, IWONICZ ZDRÓJ - POLAND

Additional Information:
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Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01188538     History of Changes
Other Study ID Numbers: RD.03.SPR.29084
First Posted: August 25, 2010    Key Record Dates
Results First Posted: July 7, 2011
Last Update Posted: April 14, 2016
Last Verified: July 2011

Keywords provided by Galderma:
P. acnes, Acne vulgaris

Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Adapalene, Benzoyl Peroxide Drug Combination
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents