A Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel in the Treatment of Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%
Onexton™ Gel
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Clindamycin and BPO Gel 1.2%/3.75%
Onexton™ Gel
Placebo
Arm Description
Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% applied to the face once daily for 84 days.
Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) applied to the face once daily for 84 days.
Placebo (vehicle of the test product) applied to the face once daily for 84 days.
Outcomes
Primary Outcome Measures
Demonstration of Bioequivalence
Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts
Secondary Outcome Measures
Clinical response of success
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.
Full Information
NCT ID
NCT02578043
First Posted
October 14, 2015
Last Updated
May 16, 2018
Sponsor
Taro Pharmaceuticals USA
1. Study Identification
Unique Protocol Identification Number
NCT02578043
Brief Title
A Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel in the Treatment of Acne Vulgaris
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
844 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clindamycin and BPO Gel 1.2%/3.75%
Arm Type
Experimental
Arm Description
Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% applied to the face once daily for 84 days.
Arm Title
Onexton™ Gel
Arm Type
Active Comparator
Arm Description
Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) applied to the face once daily for 84 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (vehicle of the test product) applied to the face once daily for 84 days.
Intervention Type
Drug
Intervention Name(s)
Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%
Other Intervention Name(s)
Clindamycin, BPO
Intervention Description
Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% (Taro Pharmaceuticals Inc.)
Intervention Type
Drug
Intervention Name(s)
Onexton™ Gel
Other Intervention Name(s)
Clindamycin, BPO
Intervention Description
Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) (Valeant Pharmaceuticals LLC)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Vehicle
Intervention Description
Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)
Primary Outcome Measure Information:
Title
Demonstration of Bioequivalence
Description
Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Clinical response of success
Description
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.
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catawba Research
Organizational Affiliation
http://catawbaresearch.com/contact/
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel in the Treatment of Acne Vulgaris
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