Clinical trial NCT02595034: A Study CLBG and Benzoyl Peroxide Gel 1%/5% to BenzaClin® Gel in the Treatment of Acne Vulgaris
Official title: A Randomized Double Blind Multiple Center Placebo Controlled Study Comparing CLBG and Benzoyl Peroxide Gel 1%/5% to BenzaClin® (Clindamycin 1%/Benzoyl Peroxide 5%) Topical Gel in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2015-11-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Change in inflammatory lesion count
timeFrame: Week 10 (day 70)
measure: Change in non-inflammatory lesion count
timeFrame: Week 10 (day 70)
Secondary outcomes:
measure: Clinical response of success
timeFrame: Week 10 (day 70)
Other outcomes:
Locations:
Study officials:
affiliation: http://catawbaresearch.com/contact/
name: Catawba Research
role: STUDY_CHAIR
References: