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Trial record 32 of 231 for:    clindamycin

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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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

Brief Summary:
The objectives of this study are to evaluate the therapeutic equivalence and safety.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% Drug: Onexton™ Gel Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 844 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : April 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015


Arm Intervention/treatment
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.
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

Active Comparator: Onexton™ Gel
Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) applied to the face once daily for 84 days.
Drug: Onexton™ Gel
Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) (Valeant Pharmaceuticals LLC)
Other Name: Clindamycin, BPO

Placebo Comparator: Placebo
Placebo (vehicle of the test product) applied to the face once daily for 84 days.
Drug: Placebo
Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)
Other Name: Vehicle




Primary Outcome Measures :
  1. Demonstration of Bioequivalence [ Time Frame: Week 12 ]
    Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02578043


Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
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Study Chair: Catawba Research http://catawbaresearch.com/contact/

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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT02578043     History of Changes
Other Study ID Numbers: CLBG 1508
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents