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Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT01880320
Recruitment Status : Completed
First Posted : June 18, 2013
Results First Posted : September 9, 2016
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Tracking Information
First Submitted Date  ICMJE June 14, 2013
First Posted Date  ICMJE June 18, 2013
Results First Submitted Date  ICMJE March 7, 2016
Results First Posted Date  ICMJE September 9, 2016
Last Update Posted Date June 28, 2018
Study Start Date  ICMJE July 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
  • Success Rate [ Time Frame: Week 12 ]
    Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA). Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets.
  • Changes From Baseline in Inflammatory Lesion Counts [ Time Frame: Baseline - Week12 ]
  • Changes From Baseline in Non-Inflammatory Lesion Counts [ Time Frame: Baseline - Week 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 17, 2013)
Composite success rate [ Time Frame: Week 12 ]
Success rate is defined as the percentage of subjects with an IGA of clear or almost clear (and therefore at least a 2-grade improvement
Change History Complete list of historical versions of study NCT01880320 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2013)
Percent Changes in Inflammatory and Non-inflammatory Lesion Counts [ Time Frame: Week12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris
Official Title  ICMJE A Multi-center, Randomized, Double-blind, Parallel-group Vehicle and Active Controlled Study to Compare the Efficacy and Safety of CD0271 0.3% / CD1579 2.5% Topical Gel Versus Topical Gel Vehicle in Subjects With Acne Vulgaris
Brief Summary

The study hypothesis are based on the assumption that :

  • CD0271 0.3%/CD1579 2.5% Gel provides superior clinical efficacy compared with Topical Gel Vehicle in the overall population and in the subgroup of severe Subjects
  • CD0271 0.3%/CD1579 2.5% Gel applied once daily for up to 12 weeks has an acceptable safety and tolerability profile
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: CD0271 0.3% / CD1579 2.5%
  • Drug: CD0271 0.1% / CD1579 2.5%
  • Drug: Topical Gel Vehicle
Study Arms  ICMJE
  • Experimental: CD0271 0.3% /CD1579 2.5% Gel
    active arm
    Intervention: Drug: CD0271 0.3% / CD1579 2.5%
  • Active Comparator: CD0271 0.1% / CD1579 2.5%
    Comparator arm
    Intervention: Drug: CD0271 0.1% / CD1579 2.5%
  • Placebo Comparator: Topical Gel Vehicle
    Placebo arm
    Intervention: Drug: Topical Gel Vehicle
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: May 26, 2014)
503
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2013)
493
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female, who is 12 years of age or older at Screening visit.
  2. Clinical diagnosis of acne vulgaris with facial involvement.
  3. An IGA of Moderate (3) or Severe (4) at Baseline visit.
  4. A minimum of 20 but not more than 100 inflammatory lesions (papules and pustules) on the face (including the nose) at Baseline visit.
  5. A minimum of 30 but not more than 150 non-inflammatory lesions (open comedones and closed comedones) on the face (including the nose) at Baseline visit.

Exclusion Criteria:

  1. More than 2 acne nodules on the face at Baseline visit.
  2. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.
  3. Underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea. This includes clinically significant abnormal findings, 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 Investigator's judgment) if he/she participates in the clinical trial.
  4. The subject has received, applied or taken some specified treatments within the specified timeframe prior to the Baseline visit
  5. The subject is unwilling to refrain from use of prohibited medication during the clinical trial.
  6. Use of hormonal contraceptives solely for control of acne.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries Russian Federation
 
Administrative Information
NCT Number  ICMJE NCT01880320
Other Study ID Numbers  ICMJE RD.06.SPR.18240
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 Not Provided
PRS Account Galderma R&D
Verification Date May 2018

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