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

NCT04134273 | Completed Phase 1

• 1 other identifier: CLPG 1809
• Study Type: interventional
• Target: 1,260
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Demonstration of Bioequivalence

  Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts.

  Week 12

Study Arms (3)

CLPG Topical Gel 1%

EXPERIMENTAL

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%

ACTIVE COMPARATOR

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

Drug: Clindamycin

Vehicle of the test product

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

CLPG Topical Gel 1% DRUG

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

Also known as: Topical Gel 1%

CLPG Topical Gel 1%

Clindamycin DRUG

Clindamycin Phosphate topical gel 1%

Also known as: Topical Gel 1%

Clindamycin Phosphate Topical Gel 1%

Placebo DRUG

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

Also known as: Vehicle

Vehicle of the test product

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

Study Sites (1)

Catawba Research, LLC

Charlotte, North Carolina, 28217, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Clindamycin

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 22, 2019
• Study Start: March 20, 2019
• Primary Completion: September 17, 2019
• Study Completion: October 15, 2019
• Last Updated: October 22, 2019

Record last verified: 2019-10

Locations

US (1)