CTRI/2018/12/016605已完成3 期
A Randomized, Double-Blind, Multicenter, Three arm, Active and Placebo Controlled, Parallel Study to Evaluate the Bioequivalence (with clinical endpoint) of Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% (Cadila Healthcare Ltd, India) to EPIDUO�® FORTE (Adapalene and Benzoyl Peroxide) Gel, 0.3%/2.5% (Galderma Laboratories, L.P., USA) in Subjects with Acne Vulgaris. - NA
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 650
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 ââ?°Â¥ 12 and ââ?°Â¤ 40 years with a clinical diagnosis of Acne vulgaris with facial involvement.
- •2. On the face, ââ?°Â¥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ââ?°Â¥ 20 inflammatory lesions (i.e., papules and pustules) AND ââ?°Â¤ 2 nodulocystic lesions (i.e., nodules and cysts).
- •3. Investigatorââ?¬•s Global Assessment (IGA) of acne severity grade 2, 3 OR 4 (refer the table below)
- •ScoreDescription
- •0Clear skin with no inflammatory or noninflammatory lesions
- •1Almost clear; rare non-inflammatory lesions with no more than one small inflammatory lesion
- •2Mild severity; greater than Grade 1;Some non-inflammatory lesions with no more than a few inflammatory lesions (papules/ pustules only, no nodular lesions)
- •3Moderate Severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion
- •4Severe; greater than Grade 3; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than a few nodular lesions
- •4. Willing to refrain from use of all other topical acne medications or antibiotics during the 12 weeks treatment period.
- •5. Male subjects and female of childbearing potential, willing to use an acceptable form of birth control including abstinence, from study start to 7 days after the last application of study medication.
- •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 (as applicable).
排除标准
- •1. Females who are breast feeding, pregnant or planning to become pregnant.
- •2. 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).
- •3. Subjects who have acne conglobata, acne fulminans and secondary acne (e.g.: chloracne and drug induced acne).
- •4. Excessive facial hair (e.g. beards, sideburns, moustaches, etc.), tattoos that would interfere with diagnosis or assessment of acne vulgaris. Well-trimmed moustaches are allowed. Subjects who have performed wax epilation of the face within 14 days prior to baseline.
- •5. History of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients.
- •6. Subjects who have a severe or intense irritation on the Face.
- •7. Use within 6 months prior to baseline (Randomization) or during the study of oral retinoids (e.g. AccutaneÃ?®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
- •8. 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.
- •9. 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 or 7) chemical or laser peel.
- •10. Use within 1 month prior to baseline (Randomization) of: 1) androgen receptor blockers for acne (such as spironolactone or flutamide), 2) systemic steroids (including intranasal and inhaled corticosteroids), 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.
- •11. Use within 2 weeks prior to baseline or during the study of 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, or 5) topical antibiotics.
- •12. Use of astringents and toners for less than 2 weeks prior to the start of the study.
- •13. Use of 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 Ã?±- or Ã?²-hydroxy acids within the previous 2 weeks
- •14. Concomitant use/planned to use of mega-doses of certain vitamins (such as vitamin D [ >2000 IU/day], vitamin B6 [ > 2 mg/day] and vitamin B12 [ > 1 mg/day]), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
- •15. Anti-pruritic, including antihistamines, within 24 hours of baseline visits
- •16. Use of tanning booths or tanning lamps within 1 week prior to baseline and an unwillingness to refrain from use during the study.
- •17. A significant medical history of or are currently immunocompromised or receiving immunomodulators/biologics since last 3 months.
- •18. Have any systemic or dermatologic disease that may affect the evaluation of study results.
- •19. Subjects with clinically signifi
研究者
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