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Bioequivalence Study of Clindamycin Gel 1% in 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: NCT03522441
Recruitment Status : Completed
First Posted : May 11, 2018
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
Catawba
Information provided by (Responsible Party):
Akorn, Inc.

Tracking Information
First Submitted Date  ICMJE April 23, 2018
First Posted Date  ICMJE May 11, 2018
Last Update Posted Date July 2, 2019
Actual Study Start Date  ICMJE April 27, 2018
Actual Primary Completion Date April 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
  • Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules) [ Time Frame: 12 weeks ]
  • Mean percent change in the non-inflammatory (open and closed comedones) lesion counts [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
The proportion of Subjects with a clinical response (IGA) of "success" at week 12. Success should be defined as an IGA score that is at least 2 grades less than the baseline assessment. [ Time Frame: 12 weeks ]
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 Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris
Official Title  ICMJE A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Clindamycin 1% Gel To Clindamycin 1% Gel (Greenstone LLC) and Both Active Treatments to Vehicle Control in the Treatment of Acne Vulgaris
Brief Summary This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1% gel (Akorn), and the marketed product Clindamycin 1% gel (Greenstone LLC) in the treatment of acne vulgaris.
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: Clindamycin 1% Gel
    Topical gel
  • Drug: Placebo
    Topical Placebo gel
Study Arms  ICMJE
  • Experimental: Clindamycin 1% gel (Akorn Pharmaceuticals)
    Intervention: Drug: Clindamycin 1% Gel
  • Active Comparator: Clindamycin 1% gel (Greenstone LLC)
    Intervention: Drug: Clindamycin 1% Gel
  • Placebo Comparator: Placebo
    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: May 10, 2018)
1125
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 22, 2019
Actual Primary Completion Date April 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

IInclusion Criteria:

  • Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris.
  • Have facial acne with: ≥20 facial inflammatory lesions (papules and pustules) and ≥25 non-inflammatory lesions (open and closed comedones), and ≤2 nodulocystic lesions (nodules and cysts) and have an IGA score of 2, 3 or 4.

Exclusion Criteria:

  • Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.
  • Subject has active cystic acne.
  • Subject has acne conglobata.
  • Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.
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 Belize,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03522441
Other Study ID Numbers  ICMJE CLMG 1711
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
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 Akorn, Inc.
Study Sponsor  ICMJE Akorn, Inc.
Collaborators  ICMJE Catawba
Investigators  ICMJE Not Provided
PRS Account Akorn, Inc.
Verification Date May 2018

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