CTRI/2018/06/014684已完成未知
A Randomized, Double blind, Multicenter, Three-arm, Parallel, Placebo-controlled, Clinical Study to Evaluate the Bioequivalence using Clinical Endpoint of Clindamycin Phosphate 1.2% and Benzoyl Peroxide 5% Gel (Encube Ethicals Private Limited, India) to DUAC® Gel (Clindamycin Phosphate 1.2% and Benzoyl Peroxide 5% Gel) (Stiefel Laboratories, Inc. Research Triangle Park, NC 27709) in Subjects with Acne Vulgaris
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •Healthy male or non-pregnant female aged more than or equal to 12 and less than or equal to 40 years with a clinical diagnosis of Acne vulgaris.
- •On the face, more than or equal to 25 non-inflammatory lesions (i.e., open and closed comedones) AND more than or equal to 20 inflammatory lesions (i.e., papules and pustules) AND less than or equal to 2 nodules.
- •Investigatorâ??s Global Assessment (IGA) of acne severity grade 2, 3 or 4 (refer Table 4).
- •Willing to refrain from use of all other topical acne medications or antibiotics during the 11 week treatment period.
- •Male subjects and Female subjects of childbearing potential agree to use accepted methods of birth control including abstinence, from study start to 7 days after the last application of study drug.
- •Willing to provide written informed consent or assent, as applicable. For subjects who are considered minors (less than 18 completed years), the parent or legal guardian should sign the consent form and the child will be required to sign a subject â??assentâ?? form, as appropriate.
排除标准
- •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).
- •Subjects who have acne conglobata, acne fulminans, nodulocystic acne and secondary acne (e.g.: chloracne and drug induced acne).
- •Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. Well-trimmed moustaches are allowed.
- •History of hypersensitivity or allergy to clindamycin or lincomycin or benzoyl peroxide and/or any of the study medication ingredients.
- •Use within 6 months prior to baseline (Randomisation) 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 (Randomisation) of estrogens or oral contraceptives; use of such therapy is allowed if it will remain constant throughout the study.
- •Use on the face within 1 month prior to baseline (Randomisation) of: 1) cryodestruction or chemodestruction, 2) dermabrasion / microdermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, 6) X-ray therapy, or 7) chemical or laser peel.
- •Use within 1 month prior to baseline (Randomisation) 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 (Randomisation) of: 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, 5) medicated cleansers/shampoo or 6) topical antibiotics.
- •Subjects who have received neuromuscular blocking agents within 14 days prior to study entry (Randomisation).
- •Used astringents and alcoholic toners for less than 2 weeks prior to the start of the study. The subject must have had an established regimen for at least 2 weeks prior to enrolment and must not have anticipated changing their regimen during the conduct of the entire study.
- •Used abradants, facials, peels containing glycolic or other acids, masks; washes or soaps containing benzoyl peroxide, salicylic acid, or sulfacetamide sodium; non-mild facial cleansers; moisturizers that contained retinol, salicylic acid or alpha or beta hydroxy acids within the previous 2 weeks.
- •Concomitant use/planned to use of mega-doses of certain vitamins (such as mega-doses of vitamin D [more than 2000 IU/day], vitamin B6 [more than 2 mg] or vitamin B12 [more than 1 mg/day]), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
- •Use of tanning booths or tanning lamps within 1 week prior to Baseline and an unwillingness to refrain from use during the study.
- •A significant medical history of or are currently immunocompromised or receiving immunomodulators/biologics since last 3 months.
- •Subjects with clinically significant vital sign abnormality.
- •Have a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.
- •Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies
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