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Exploratory Study to Evaluate the Efficacy and Safety of CD07223 Gel in Subjects With Acne

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ClinicalTrials.gov Identifier: NCT01106807
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Tracking Information
First Submitted Date  ICMJE April 19, 2010
First Posted Date  ICMJE April 20, 2010
Last Update Posted Date February 18, 2021
Study Start Date  ICMJE April 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2011)
  • Total acne lesion count [ Time Frame: 6 weeks ]
    change in total number of acne lesion count from baseline to end of treatment
  • Percent change of acne lesion count [ Time Frame: 6 weeks ]
    Percent change of acne lesion count from baseline to end of treatment
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2010)
Total acne lesion count [ Time Frame: 6 weeks ]
percent reduction from baseline at end of treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2011)
  • Lesion counts- Inflammatory [ Time Frame: 6 weeks ]
    change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject
  • Lesion count- non-inflammatory [ Time Frame: 6 weeks ]
    change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject
  • Lesion counts- Inflammatory [ Time Frame: 6 weeks ]
    Percent change of acne lesion count from baseline at each evaluation visit
  • Lesion count- non-inflammatory [ Time Frame: 6 weeks ]
    Percent change of acne lesion count from baseline at each evaluation visit
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2010)
Lesion counts- Inflammatory and non-inflammatory [ Time Frame: 6 weeks ]
percent reduction from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploratory Study to Evaluate the Efficacy and Safety of CD07223 Gel in Subjects With Acne
Official Title  ICMJE Exploratory Study to Evaluate the Efficacy and Safety of CD07223 1.5% Gel and 0.5% Gel in Subjects With Acne
Brief Summary The purpose of the study is to evaluate the efficacy of CD07223 1.5% Gel and 0.5% gel in reducing inflammatory, non-inflammatory, and total acne lesion counts after 6 weeks of twice daily applications. The study will also evaluate the safety of the study products using tolerance and adverse event data.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne
Intervention  ICMJE
  • Drug: Epiduo vehicle gel
    500 microliters of Epiduo vehicle gel on one half-face twice daily for six weeks
  • Drug: CD07223
    500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks
  • Drug: CD07223
    500 microliters of CD07223 0.5% gel on one half-face twice daily for six weeks
  • Drug: Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel
    500 microliters Epiduo Gel on one of the half-face for the morning dose
Study Arms  ICMJE
  • Experimental: CD07223 1.5% gel
    500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks and Epiduo vehicle gel on the other half-face
    Interventions:
    • Drug: Epiduo vehicle gel
    • Drug: CD07223
  • Experimental: CD07223 0.5% gel
    500 microliters of CD07223 0.5% gel on one half-face twice daily for six weeks and Epiduo vehicle gel on the other half-face
    Interventions:
    • Drug: Epiduo vehicle gel
    • Drug: CD07223
  • Active Comparator: Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel
    500 microliters of Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel on one half-face and 500 microliters of the Epiduo vehicle gel on the other half-face in the morning and in the afternoon, 500 microliters of Epiduo vehicle gel on both half-faces
    Interventions:
    • Drug: Epiduo vehicle gel
    • Drug: Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel
Publications * Not Provided

*   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: February 3, 2011)
73
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2010)
72
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • subject has a clinical diagnosis of acne vulgaris with facial involvement
  • the subject has at least 15 inflammatory lesions and 25 non-inflammatory lesions (excluding the nose) but no more than 2 nodules on the face

Exclusion Criteria:

  • subject has a severe acne form or secondary acne form
  • the number of inflammatory or non-inflammatory lesions on one half-face is greater than twice the number on the other half-face
  • the subject has a known allergy or sensitivity to any of the components of the study products
  • subject is not willing to respect wash-out periods for topical and/or systemic treatments
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01106807
Other Study ID Numbers  ICMJE RD.06.SPR.18173
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Galderma R&D
Study Sponsor  ICMJE Galderma R&D
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael Graeber, MD Galderma R&D
PRS Account Galderma R&D
Verification Date April 2012

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