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A Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel in the Treatment of Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02578043
Recruitment Status : Completed
First Posted : October 16, 2015
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Tracking Information
First Submitted Date  ICMJE October 14, 2015
First Posted Date  ICMJE October 16, 2015
Last Update Posted Date May 18, 2018
Study Start Date  ICMJE April 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2018)
Demonstration of Bioequivalence [ Time Frame: Week 12 ]
Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts
Original Primary Outcome Measures  ICMJE
 (submitted: October 15, 2015)
  • Change in inflammatory lesion counts [ Time Frame: Week 12 ]
    Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts.
  • Change in non-inflammatory lesion counts [ Time Frame: Week 12 ]
    Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts.
Change History Complete list of historical versions of study NCT02578043 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2015)
Clinical response of success [ Time Frame: Week 12 ]
The proportion of subjects with a clinical response of success at week 12 defined as an Investigator's Global Assessment score that is at least 2 grades less than the baseline assessment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel in the Treatment of Acne Vulgaris
Official Title  ICMJE A Multi Center Double Blind Randomized Placebo Controlled Parallel Group Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Brief Summary The objectives of this study are to evaluate the therapeutic equivalence and safety.
Detailed Description The objectives of this study are to evaluate the therapeutic equivalence and safety of the test product Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to the reference product Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of these test and reference products over the placebo control.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%
    Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% (Taro Pharmaceuticals Inc.)
    Other Name: Clindamycin, BPO
  • Drug: Onexton™ Gel
    Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) (Valeant Pharmaceuticals LLC)
    Other Name: Clindamycin, BPO
  • Drug: Placebo
    Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)
    Other Name: Vehicle
Study Arms  ICMJE
  • Experimental: Clindamycin and BPO Gel 1.2%/3.75%
    Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% applied to the face once daily for 84 days.
    Intervention: Drug: Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%
  • Active Comparator: Onexton™ Gel
    Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) applied to the face once daily for 84 days.
    Intervention: Drug: Onexton™ Gel
  • Placebo Comparator: Placebo
    Placebo (vehicle of the test product) applied to the face once daily for 84 days.
    Intervention: Drug: Placebo
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: October 15, 2015)
844
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
  • Must have a minimum ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.
  • Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.

Exclusion Criteria:

  • Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
  • A history or presence of Crohn's disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis.
  • A history of hypersensitivity or allergy to clindamycin, benzoyl peroxide and/or any of the study medication ingredients and its excipients.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 40 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 Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT02578043
Other Study ID Numbers  ICMJE CLBG 1508
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Taro Pharmaceuticals USA
Study Sponsor  ICMJE Taro Pharmaceuticals USA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Catawba Research http://catawbaresearch.com/contact/
PRS Account Taro Pharmaceuticals USA
Verification Date May 2018

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