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

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.

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

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Placebo; Drug: CLPG Topical Gel 1%; Drug: Clindamycin

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.

• Study Type: Interventional
• Enrollment (Actual): 1260
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28217
      • Catawba Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demonstration of Bioequivalence	Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts.	Week 12

Collaborators and Investigators

• Sponsor: Taro Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2019
• Primary Completion (Actual): September 17, 2019
• Study Completion (Actual): October 15, 2019

Study Registration Dates

• First Submitted: October 18, 2019
• First Submitted That Met QC Criteria: October 18, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 18, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Clindamycin; Clindamycin palmitate; Clindamycin phosphate
• Other Study ID Numbers: CLPG 1809

Drug and device information, study documents

• 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