CTRI/2020/07/026391已完成1 期
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Three-arm, Parallel Study to Evaluate the Bioequivalence using Clinical Endpoint of Tretinoin Gel microsphere, 0.08% (Encube Ethicals Private Limited, India) to Retin-A Micro (tretinoin) Gel microsphere 0.08% (Valeant Pharmaceuticals North America LLC, NJ 08807) in Subjects with Acne Vulgaris
试验速览
- 阶段
- 1 期
- 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
- Interventional
入排标准
入选标准
- •1. Healthy male or non-pregnant, non- lactating female aged >= 12 and <= 40 years with a clinical diagnosis of Acne vulgaris (AV).
- •2. On the face, having >= 20 inflammatory (i.e., papules and pustules), >= 25 non-inflammatory (i.e., open and closed comedones) lesions and <= 2 nodulocystic lesions (i.e, nodules and cysts).
- •3.Investigatorâ??s Global Assessment (IGA) of acne severity grade 2, 3 or 4.
- •4.Willing to refrain from use of all other topical products (moisturizer, new brands of make-up, creams, lotions, powders or any other topical product), all acne medications and antibiotics during the 12 weeks treatment period.
- •5.Female subjects of child bearing potential practicing an approved method of contraception and willing to continue its use from study entry to 7 days after the administration of study drug and have a negative Urine Pregnancy Test at the time of screening
- •Female subjects of non-child bearing potential.
- •Note: Approved methods of contraception include Hormonal contraception including oral, systemic injectable or Intra-uterine Contraceptive Devices must have been on a stable dose for 3 months prior to study entry, bilateral tubal ligation or tubectomy, non-hormonal IUCD, double barrier or strict abstinence.
- •Use of oral contraceptive therapy is allowed if it shall remain constant throughout the study. Non-child bearing potential is defined as pre-menarche, postmenopausal absence of menstrual bleeding for 1 year prior to enrolment, hysterectomy or bilateral oophorectomy.
- •6. Male subjects must use accepted methods of birth control or must agree to practice abstinence from study entry to 7 days after the administration of study drug.
- •7. Willing to provide written informed consent or assent, as applicable. For subjects who are considered minors ( < 18 completed years), the parent or legal guardian shall sign the consent form and the child shall be required to sign a subject â??assentâ?? form, as appropriate
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. Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that shall interfere with diagnosis or assessment of acne vulgaris. Well-trimmed moustaches are allowed.
- •3. History of hypersensitivity or allergy to tretinoin, retinoids and/or any of the study medication ingredients.
- •4. 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).
- •5. Use for less than 3 months prior to baseline (Randomisation) of estrogens or oral contraceptives or any other hormonal therapy; use of such therapy is allowed if it shall remain constant throughout the study.
- •6. Use on the face within 1 month prior to baseline (Randomisation) cryo-destruction or chemo-destruction, dermabrasion / microdermabrasion, photodynamic therapy, acne surgery, intralesional steroids, X-ray therapy, chemical or laser peel.
- •7. Use within 1 month prior to baseline (Randomisation) of androgen receptor blockers for acne (spironolactone, Flutamide etc.,), systemic steroids (Including intra-nasal and in-haled corticosteroids), systemic antibiotics, systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout) or systemic anti-inflammatory agents.
- •8. Use within 2 weeks prior to baseline (Randomisation) of topical steroids, topical retinoids and topical acne treatments including over-the-counter preparations, topical anti-inflammatory agents, medicated cleansers/shampoo or topical antibiotics.
- •9. Use within 2 weeks prior to baseline (Randomisation) of abradants, facials, peels containing glycolic or other acids, masks, washes or soaps, containing glycolic acid, salicylic acid, Alpha- or beta-hydroxy acids or other acids, benzoyl peroxide (BPO) or sulfacetamide sodium, non-mild facial cleansers, moisturizers that contained retinol.
- •10. Subjects who have undergone a facial procedure (e.g., laser peel, microdermabrasion or blue light treatment, etc.) within the past 4 weeks or if it is planned to be performed during the conduct of the study.
- •11. Concomitant use/planned to use of mega-doses of certain vitamins (such as mega-doses of vitamin D [ > 2000 IU/day], vitamin B6 [ > 2 mg] or vitamin B12 [ > 1 mg/day]), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
- •12. Use of tanning booths or tanning lamps or ultraviolet light within 1 week prior to Baseline and an unwillingness to refrain from use during the study.
- •13. Subjects with planned unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.).
- •14. A significant medical history of or are currently immunocompromised or receiving immunomodulators/ biologics since last 3 months.
- •15. Subjects with clinically significant vital sign abnormality.
- •16. Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.
- •17. Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as
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