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

NCT02595034 | Completed Phase 1

• 1 other identifier: CLBG 1412
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• Change in inflammatory lesion count

  Mean percent change from baseline to week 10 (study day 70) in the inflammatory (papules and pustules) lesion counts.

  Week 10 (day 70)

• Change in non-inflammatory lesion count

  Mean percent change from baseline to week 10 (study day 70) in the non-inflammatory (open and closed comedones) lesion counts.

  Week 10 (day 70)

Secondary Outcomes (1)

• Clinical response of success

  Week 10 (day 70)

Study Arms (3)

Clindamycin/BP Gel 1%5%

EXPERIMENTAL

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

Drug: Clindamycin and Benzoyl Peroxide Gel 1%5%

BenzaClin® Topical Gel

ACTIVE COMPARATOR

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

Drug: BenzaClin® Topical Gel

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Clindamycin and Benzoyl Peroxide Gel 1%5% DRUG

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

Also known as: Active

Clindamycin/BP Gel 1%5%

BenzaClin® Topical Gel DRUG

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

Also known as: Active

BenzaClin® Topical Gel

Placebo DRUG

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

Also known as: Vehicle

Placebo

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 nonpregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
• 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).
• Investigator's Global Assessment (IGA) of acne severity grade 2, 3, or 4
• Willing to refrain from use of all other topical acne medications or antibiotics during the 10week treatment period.
• If female of childbearing potential, willing to use an acceptable form of birth control during the study.

You may not qualify if:

• 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).
• Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
• History of hypersensitivity or allergy to benzoyl peroxide or clindamycin and/or any of the study medication ingredients.
• 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).
• Use for less than 3 months prior to baseline of estrogens or oral contraceptives; use of such therapy must remain constant throughout the study.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Clindamycin; Exercise

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; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Catawba Research

  http://catawbaresearch.com/contact/

  STUDY CHAIR

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: November 1, 2015
• First Posted: November 3, 2015
• Study Start: January 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 4, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share