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Trial record 21 of 83 for:    acne AND Acne Scars

Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel and Risk of Formation of Atrophic Acne Scars (OSCAR)

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ClinicalTrials.gov Identifier: NCT02735421
Recruitment Status : Completed
First Posted : April 12, 2016
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
Galderma

Tracking Information
First Submitted Date  ICMJE April 7, 2016
First Posted Date  ICMJE April 12, 2016
Last Update Posted Date January 8, 2018
Actual Study Start Date  ICMJE May 13, 2016
Actual Primary Completion Date June 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2016)
Total atrophic acne scar count per half-face [ Time Frame: Week 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02735421 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel and Risk of Formation of Atrophic Acne Scars
Official Title  ICMJE Effect of Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel Versus Vehicle Gel on the Risk of Formation of Atrophic Acne Scars in Moderate to Severe Acne Subjects
Brief Summary

This is a multi-centre, randomized, investigator blinded, vehicle controlled trial using intra-individual comparison (right half-face versus left half-face).

Subjects will have each half-face randomized to one of the two following treatments:

  • Adapalene 0.3% - BPO 2.5% gel (TactuPump® Forte).
  • Vehicle gel

The main objective of this trial is to evaluate the effect of Adapalene 0.3% - benzoyl peroxide (BPO) 2.5% gel versus vehicle gel on the risk of formation of atrophic acne scars in moderate to severe acne subjects.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Acne Vulgaris
  • Atrophic Acne Scars
Intervention  ICMJE
  • Drug: Adapalene 0.3% / BPO 2.5% gel
    Other Name: TactuPump Forte
  • Drug: Vehicle gel
Study Arms  ICMJE
  • Experimental: Adapalene / BPO gel
    Adapalene 0.3% / BPO 2.5% gel, once daily in the evening on half of the face (determined by randomization)
    Intervention: Drug: Adapalene 0.3% / BPO 2.5% gel
  • Placebo Comparator: Vehicle gel
    Vehicle gel, once daily in the evening on half of the face (determined by randomization)
    Intervention: Drug: Vehicle gel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 2, 2017)
67
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2016)
60
Actual Study Completion Date  ICMJE November 23, 2017
Actual Primary Completion Date June 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Main Inclusion Criteria:

  • Subject with clinical diagnosis of moderate to severe acne vulgaris on the face defined by:

    1. Investigator's Global Assessment score of 3 or 4, with same score on both sides; and
    2. A minimum of 25 inflammatory lesions (papules and pustules) in total, with at least 10 on each side (excluding the nose); and
    3. No more than two acne nodules (≥ 1 cm); and
    4. A minimum of 10 atrophic acne scars in total (upper than 2 mm) (excluding the nose).
  • Subject with a symmetric number of both inflammatory and non-inflammatory lesions on the whole face, and atrophic acne scars on the whole face
  • Subject with skin phototype of I to IV on Fitzpatrick's scale

Main Exclusion Criteria:

  • Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, acne requiring systemic treatment.
  • Prior failure to treatment with TactuPump® Forte (Adapalene 0.3% - BPO 2.5%).
  • Subject with more than 3 excoriated acne lesions.
  • Subject with skin abraded on the treated area or affected by eczema, seborrhoeic dermatitis, cuts or sunburn.
  • Female subject who is pregnant, nursing or planning a pregnancy during the trial or within one month after the last trial treatment application
  • Male subject with a beard or facial hair, which would interfere with the clinical trial evaluations or clinical trial procedures
  • Subject having received at least one of the following topical treatments on the treated area: Corticosteroids, antibiotics, benzoyl peroxide, azelaic acid, hydroxyacids, Zinc containing treatments, antibacterials, antiseptics, other anti-inflammatory drugs or other acne treatments (2 weeks); Retinoids (4 weeks); Cosmetic/aesthetic procedures on the face (1 week); Photodynamic therapy, laser therapy, microdermabrasion for acne (3 months)
  • Subject having received at least one of the following systemic treatments: Corticosteroids (except locally acting corticosteroids such as inhaled or intrathecal or dermal application at distance from the face), antibiotics (except penicillin) (1 month); Spironolactone (3 months) / Drospirenone (3 months, unless dose is stable since at least 3 months); Oral retinoids (6 months); Cyproterone acetate / Chlormadinone acetate (6 months); Immunomodulators (3 months)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02735421
Other Study ID Numbers  ICMJE RD.03.SPR.105061
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Galderma
Study Sponsor  ICMJE Galderma
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Galderma
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP