A Study CLBG and Benzoyl Peroxide Gel 1%/5% to BenzaClin® Gel in the Treatment of Acne Vulgaris

NCT ID: NCT02595034

Last Updated: 2017-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-11-30

Brief Summary

This study is to evaluate the therapeutic equivalence and safety of Clindamycin and Benzoyl Peroxide Gel 1%/5% and BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel

Detailed Description

The objectives of this study are to evaluate the therapeutic equivalence and safety of Clindamycin and Benzoyl Peroxide Gel 1%/5% (Taro Pharmaceuticals Inc.) and BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel (Sanofi Aventis, US) 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

Clindamycin/BP Gel 1%5%

Clindamycin and Benzoyl Peroxide Gel 1%/5% applied twice daily (morning and evening) for 70 days (10 weeks).

Group Type: EXPERIMENTAL

Clindamycin and Benzoyl Peroxide Gel 1%5%

Intervention Type: DRUG

Clindamycin and Benzoyl Peroxide Gel 1%5% (Taro Pharmaceuticals Inc.)

BenzaClin® Topical Gel

BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel applied twice daily (morning and evening) for 70 days (10 weeks).

Group Type: ACTIVE_COMPARATOR

BenzaClin® Topical Gel

Intervention Type: DRUG

BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel (Sanofi Aventis, U.S.)

Placebo

Placebo (vehicle of the test product) applied twice daily (morning and evening) for 70 days (10 weeks).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Clindamycin and Benzoyl Peroxide Gel 1%5%

Clindamycin and Benzoyl Peroxide Gel 1%5% (Taro Pharmaceuticals Inc.)

Intervention Type: DRUG

BenzaClin® Topical Gel

BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel (Sanofi Aventis, U.S.)

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Active; Active; Vehicle

Eligibility Criteria

Inclusion Criteria

1. Healthy male or nonpregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.

2. On the face, ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤ 2 nodulocystic lesions (i.e., nodules and cysts).

3. Investigator's Global Assessment (IGA) of acne severity grade 2, 3, or 4

4. Willing to refrain from use of all other topical acne medications or antibiotics during the 10week treatment period.

5. If female of childbearing potential, willing to use an acceptable form of birth control during the study.

Exclusion Criteria

1. 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, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).

2. Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.

3. History of hypersensitivity or allergy to benzoyl peroxide or clindamycin and/or any of the study medication ingredients.

4. Use within 6 months prior to baseline of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).

5. Use for less than 3 months prior to baseline of estrogens or oral contraceptives; use of such therapy must remain constant throughout the study.

6. Use on the face within 1 month prior to baseline or during the study of: 1) cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy.

7. Use within 1 month prior to baseline of: 1) spironolactone, 2) systemic steroids, 3) systemic antibiotics, 4) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or 5) systemic anti-inflammatory agents.

8. Use within 2 weeks prior to baseline of: 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, 5) medicated cleansers or 6) topical antibiotics.

• 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

Principal Investigators

Catawba Research

Role: STUDY_CHAIR

http://catawbaresearch.com/contact/

Other Identifiers

CLBG 1412

Identifier Type: -

Identifier Source: org_study_id