CTRI/2022/11/047272已完成未知
A Randomized, Double-Blind, Multicenter, Three arm, Active and Placebo-Controlled, Parallel Design Study to Evaluate the Bioequivalence (withClinical Endpoint) of Tretinoin Cream USP, 0.025% of Encube Ethicals Pvt. Ltd., India Versus RETIN-A® (Tretinoin) Cream, 0.025% of Bausch Health US, LLC Bridgewater, NJ 08807 USA in Subjects with Acne Vulgaris.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 1,060
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
- •Subjects will be eligible for inclusion in this study only if all of the following criteria apply:
- •1. Male or non-pregnant, non-lactating 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 (Refer Table 8-2).
- •4. Willing and able to refrain from use of all other topical products, all acne medications and all antibiotics (other than study treatment) during the 12-week treatment period.
- •5. Willing to provide written informed consent or assent (as applicable).
- •6. If female of childbearing potential, willing to use an acceptable form of birth control during the entire study duration.
- •7. 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.
- •8. Subject who received COVID-19 vaccine should have recovered from vaccine related side effects prior to screening.
排除标准
- •Subjects will be eligible for inclusion in this study only if all of the following criteria apply:
- •1. Male or non-pregnant, non-lactating 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 (Refer Table 8-2).
- •4. Willing and able to refrain from use of all other topical products, all acne medications and all antibiotics (other than study treatment) during the 12-week treatment period.
- •5. Willing to provide written informed consent or assent (as applicable).
- •6. If female of childbearing potential, willing to use an acceptable form of birth control during the entire study duration.
- •7. 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.
- •8. Subject who received COVID-19 vaccine should have recovered from vaccine related side effects prior to screening.
- •Exclusion Criteria:
- •Subjects will not be eligible for inclusion in this study if any of the following criteria apply:
- •1. Female who is breastfeeding, pregnant or planning to become pregnant.
- •2. Subject who has acne conglobata, acne fulminans, nodulocystic acne and secondary acne (e.g., chloracne and drug induced acne).
- •3. Subject who has clear symptoms of severe or intense irritation on the face.
- •4. 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, acne form eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
- •5. Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that would interfere with the diagnosis or assessment of acne vulgaris. Well-trimmed moustaches are allowed.
- •6. History of hypersensitivity or allergy to tretinoin, retinoids, or any of the investigational product ingredients.
- •7. Use within 6 months prior to the baseline of oral retinoids (e.g., Accutane®) or therapeutic Vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
- •8. Use for less than 3 months prior to the baseline of estrogens or oral contraceptives; use of such therapy must remain constant throughout the study.
- •9. Use on the face within 1 month prior to baseline of 1) Cryodestruction or Chemodestruction, 2) Dermabrasion, 3) Photodynamic therapy, 4) Acne surgery, 5) Intralesional steroids, or 6) X-ray therapy.
- •10. Use within 1 month prior to baseline of 1) Spironolactone 2) Systemic steroids 3) Systemic (e.g., oral or injectable) antibiotics 4) Systemic treatment for acne vulgaris (other than oral retinoids which require a 6-month washout) or 5) Systemic anti-inflammatory agents or immunosuppressive drugs.
- •11. Use within 2 weeks prior to baseline of 1) Topical steroids, 2) Topical retinoid 3) Topical acne treatments including over-the-counter preparations 4) Topical anti-inflammatory agents, or 5) Topical antibiotics 6) Astringents and toners 7) abradants, facials, peels containing glycolic or other acids 8) masks 9) wash
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