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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: NCT04321070
Recruitment Status : Completed
First Posted : March 25, 2020
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Brief Summary:
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Clindamycin Phosphate Drug: Clindamycin Phosphate RLD Drug: Placebos Phase 1

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 550 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 : September 9, 2019
Actual Primary Completion Date : December 14, 2019
Actual Study Completion Date : March 6, 2020


Arm Intervention/treatment
Experimental: Clindamycin Phosphate
Topical, once daily, for 84 days.
Drug: Clindamycin Phosphate
A thin film of investigation product will be applied to the affected areas of the face once daily
Other Name: Lotion

Active Comparator: Clindamycin Phosphate RLD
Topical, once daily, for 84 days
Drug: Clindamycin Phosphate RLD
A thin film of investigation product will be applied to the affected areas of the face once daily
Other Name: Lotion

Placebo Comparator: Vehicle of the test product
Topical, once daily, for 84 days
Drug: Placebos
A thin film of investigation product will be applied to the affected areas of the face once daily
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



Information from the National Library of Medicine

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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 ≤ 40years 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 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 history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients, have a known hypersensitivity to adapalene and benzoyl peroxide and its excitements.

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): NCT04321070


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: NCT04321070    
Other Study ID Numbers: CLPL 1907
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: 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