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Dose Range Study of CD5789 in Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT01616654
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : February 11, 2014
Sponsor:
Information provided by (Responsible Party):
Galderma

Tracking Information
First Submitted Date  ICMJE June 8, 2012
First Posted Date  ICMJE June 12, 2012
Last Update Posted Date February 11, 2014
Study Start Date  ICMJE June 2012
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2012)
  • Success Rate (IGA) [ Time Frame: up to Week 12 ]
    Defined as the percentage of subjects who achieve at least a two-point reduction in the IGA score from Baseline at Week 12, Last Observation Carried Forward (LOCF), Intent to Treat (ITT) population.
  • Absolute change in total lesion counts [ Time Frame: Baseline to Week 12 ]
    Absolute change in total lesion counts from Baseline to Week 12; total lesion counts is the sum of inflammatory, non-inflammatory lesions and nodules.
  • Percent Change in total lesion counts [ Time Frame: Baseline to Week 12 ]
    Percent change in total lesion counts from Baseline to Week 12; total lesion counts is the sum of inflammatory, non-inflammatory lesions and nodules
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2012)
  • Success Rate (IGA) [ Time Frame: up to Week 12 ]
    Defined as the percentage of subjects who achieve at least a two-point reduction in the IGA score from Baseline at Week 12, Last Observation Carried Forward (LOCF), Intent to Treat (ITT) population.
  • Absolute and percent change in total lesion counts [ Time Frame: Baseline to Week 12 ]
    Absolute and percent change in total lesion counts from Baseline to Week 12; total lesion counts is the sum of inflammatory, non-inflammatory lesions and nodules.
Change History Complete list of historical versions of study NCT01616654 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 Dose Range Study of CD5789 in Acne Vulgaris
Official Title  ICMJE A Randomized, Multi-center, Investigator-blind, Vehicle- and Active-controlled, Phase 2 Study to Assess the Efficacy and Safety of Different Concentrations of CD5789 Cream Applied Once Daily in Subjects With Moderate to Severe Acne Vulgaris
Brief Summary To assess the efficacy and safety of different concentrations of CD5789 cream in subjects with acne vulgaris for the purpose of dose identification.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: CD5789 25 µg/g cream
    CD5789 25 µg/g cream applied once daily
  • Drug: CD5789 50 µg/g cream
    CD5789 50 µg/g cream applied once daily
  • Drug: CD5789 100 µg/g cream
    CD5789 100 µg/g cream applied once daily
  • Drug: Tazarotene 0.1% gel
    Tazarotene 0.1% gel applied once daily
  • Drug: Vehicle cream
    Vehicle cream applied once daily
Study Arms  ICMJE
  • Experimental: CD5789 50 µg/g cream
    CD5789 50 µg/g cream applied once daily for subjects randomized in Stratum 1, 2 and 3
    Intervention: Drug: CD5789 50 µg/g cream
  • Experimental: CD5789 100 µg/g cream
    CD5789 100 µg/g cream applied once daily for subjects randomized in Stratum 1, 2 and 3
    Intervention: Drug: CD5789 100 µg/g cream
  • Active Comparator: Tazarotene 0.1% gel
    Tazarotene 0.1% gel applied once daily for subjects randomized in Stratum 1 and 2
    Intervention: Drug: Tazarotene 0.1% gel
  • Placebo Comparator: Vehicle cream
    Vehicle cream applied once daily for subjects randomized in Stratum 1, 2 and 3
    Intervention: Drug: Vehicle cream
  • Experimental: CD5789 25 µg/g cream
    CD5789 25 µg/g cream applied once daily for subjects randomized in Stratum 1, 2 and 3
    Intervention: Drug: CD5789 25 µg/g cream
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: August 5, 2013)
304
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2012)
328
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subject, 12 to 35 years old with the following characteristics:
  • Facial acne severity grade of the following:

    • Stratum 1: IGA score of 3 or 4
    • Stratum 2: IGA score of 4
    • Stratum 3: IGA score of 3 or 4
  • A minimum of 30 non-inflammatory lesions and fulfills the criteria of one of the following strata:

    • Stratum 1: A minimum of 20 but not more than 40 inflammatory lesions, and a maximum of one nodule on the face.
    • Stratum 2: More than 40 inflammatory lesions, and up to four nodules on the face.
    • Stratum 3: Subjects of Japanese origin with at least 20 inflammatory lesions and up to four nodules on the face.

      • Note: Subjects of Japanese origin will not be included in Stratum 1 or Stratum 2. Japanese origin is defined as all four grandparents were born in Japan.

Exclusion Criteria:

  • The presence of severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.)
  • Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results and/or put the subject at significant risk (according to the Investigator's judgment) if the subject participates in the clinical trial.
  • Known or suspected allergies or sensitivities to any components of any of the study drugs.
  • Current participation in any other clinical trial of a drug or device OR past participation within the 30 days prior to the Baseline visit.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01616654
Other Study ID Numbers  ICMJE RD.06.SPR18223
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
Study Director: Michael Graeber, M.D. Galderma R&D, Inc.
PRS Account Galderma
Verification Date January 2014

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