A Study CLBG and Benzoyl Peroxide Gel 1%/5% to BenzaClin® Gel in the Treatment of Acne Vulgaris
Status: | Completed |
---|---|
Conditions: | Acne, Acne, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 12 - 40 |
Updated: | 5/5/2017 |
Start Date: | January 2015 |
End Date: | November 2015 |
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
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
Peroxide Gel 1%/5% and BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel
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
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
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.
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