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

NCT ID: NCT04134273

Last Updated: 2019-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 1260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-20
• Study Completion Date: 2019-10-15

Brief Summary

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

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CLPG Topical Gel 1%

Clindamycin Phosphate Topical Gel 1%, applied to the face twice a day for 84 days.

Group Type: EXPERIMENTAL

CLPG Topical Gel 1%

Intervention Type: DRUG

Clindamycin Phosphate Topical Gel 1% (Taro Pharmaceuticals U.S.A, Inc.)

Clindamycin Phosphate Topical Gel 1%

Clindamycin Phosphate Topical Gel 1%, applied to the face twice a day for 84 days.

Group Type: ACTIVE_COMPARATOR

Clindamycin

Intervention Type: DRUG

Clindamycin Phosphate topical gel 1%

Vehicle of the test product

Placebo (vehicle of the test product), applied to the face twice a day for 84 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)

Interventions

CLPG Topical Gel 1%

Clindamycin Phosphate Topical Gel 1% (Taro Pharmaceuticals U.S.A, Inc.)

Intervention Type: DRUG

Clindamycin

Clindamycin Phosphate topical gel 1%

Intervention Type: DRUG

Placebo

Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)

Intervention Type: DRUG

Other Intervention Names

Topical Gel 1%; Topical Gel 1%; Vehicle

Eligibility 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).

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Pharmaceutical Industries, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Catawba Research, LLC

Charlotte, North Carolina, United States

Countries

United States

Other Identifiers

CLPG 1809

Identifier Type: -

Identifier Source: org_study_id