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Bio-equivalence Study With Clinical Endpoints 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: NCT04134273
Recruitment Status : Completed
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Brief Summary:
This study is to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: CLPG Topical Gel 1% Drug: Clindamycin Drug: Placebo Phase 1

Detailed Description:
The study objectives are to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo control.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris.
Actual Study Start Date : March 20, 2019
Actual Primary Completion Date : September 17, 2019
Actual Study Completion Date : October 15, 2019


Arm Intervention/treatment
Experimental: CLPG Topical Gel 1%
Clindamycin Phosphate Topical Gel 1%, applied to the face twice a day for 84 days.
Drug: CLPG Topical Gel 1%
Clindamycin Phosphate Topical Gel 1% (Taro Pharmaceuticals U.S.A, Inc.)
Other Name: Topical Gel 1%

Active Comparator: Clindamycin Phosphate Topical Gel 1%
Clindamycin Phosphate Topical Gel 1%, applied to the face twice a day for 84 days.
Drug: Clindamycin
Clindamycin Phosphate topical gel 1%
Other Name: Topical Gel 1%

Placebo Comparator: Vehicle of the test product
Placebo (vehicle of the test product), applied to the face twice a day 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.



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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
  • Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects 12 to 17 years of age, inclusive, must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian).
  • Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).

Exclusion Criteria:

  • Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
  • Subjects with a known hypersensitivity to clindamycin or lincomycin and/or any ingredients in the study drugs.
  • Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).

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): NCT04134273


Locations
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United States, North Carolina
Catawba Research, LLC
Charlotte, North Carolina, United States, 28217
Sponsors and Collaborators
Taro Pharmaceuticals USA
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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT04134273    
Other Study ID Numbers: CLPG 1809
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019

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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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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action