CTRI/2015/11/006379尚未招募3 期
A Randomized, Double-blind, Multicentric, Parallel-group, Active and Placebo Controlled, Three Arm Clinical Study to Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel (of Cadila Healthcare Limited, India) versus DUAC® Gel (of Stiefel Laboratories, USA) versus Placebo (Vehicle Gel) in the ratio of 2:2:1 respectively, in Patients with Acne Vulgaris.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 850
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Healthy male or non pregnant 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. Investigatorâ??s Global Assessment (IGA) of acne severity grade 2,3 OR 4 (per Table 1)
- •4.Willing to refrain from use of all other topical acne medications or antibiotics during the 11 week treatment period.
- •5.If female of childbearing potential, willing to use an acceptable form of birth control during the study.
- •6. Have used the same brand of make-up for a minimum period of 2 weeks prior to randomization, for subjects who use make-up, and agree to not change make-up brands or types during the study.
- •7.Willing to provide written informed consent or assent (HIPAA consent/authorization, as applicable).
排除标准
- •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.Patients who have acne conglobata, acne fulminans and secondary acne (e.g.: chloracne and drug induced acne).
- •3.Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. Well trimmed moustaches are allowed.
- •4.History of hypersensitivity or allergy to benzoyl peroxide or clindamycin and/or any of the study medication ingredients.
- •5.Patients who have a severe or intense irritation on the Face.
- •6.Use within 6 months prior to baseline (Randomization) of oral retinoids (e.g.
- •Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
- •7.Use for less than 3 months prior to baseline (Randomization) of estrogens or oral contraceptives; use of such therapy is allowed if it will remain constant throughout the study.
- •8.Use on the face within 1 month prior to baseline (Randomization) 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.
- •9.Use within 1 month prior to baseline (Randomization) 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.
- •10.Use within 2 weeks prior to baseline (Randomization) 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.
- •11.Patients who have had general anesthesia for any reason and patients who have received neuromuscular blocking agents within 14 days prior to study entry (Randomization).
- •12.Concomitant use of facial product containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or α- or β-hydroxy acids.
- •13.Concomitant use of mega-doses of certain vitamins (such as vitamin D and vitamin B12), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
- •14.Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2 weeks or during the study.
- •15.Concomitant use of tanning booths or sunbathing.
- •16.A significant medical history of or are currently immunocompromised
- •17.Have any systemic or dermatologic disease that may affect the evaluation of study results.
- •18.Have a history of regional enteritis, ulcerative colitis, pseudomembranous colitis or antibiotic-associated colitis.
- •19.Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.
- •20.Subjects who engage in activities that involve excessive or prolonged exposure to sunlight.
- •21.Subjects with History of Alcohol abuse or other drugs of abuse within 2 years prior to Randomization.
- •22.Female subjects who are breast-feeding or planning t
研究者
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