CTRI/2017/09/009884尚未招募1 期
A multicenter, randomized, double blind, parallel, placebo controlled clinical endpoint study to determine the therapeutic equivalence of Test Product Benzoyl peroxide 5% and Clindamycin Phosphate 1% gel and Reference Product BenzaClin Topical Gel in patients with Acne Vulgaris.
Alvogen Pine Brook LLC0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
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
- •1. Healthy male or non-pregnant female aged greater than or equal to 12 and less than or equal to 40 years with a clinical diagnosis of acne vulgaris.
- •2. Patients who are 18 years of age or older (up to the age of 40) must have provided Institutional Review Board (IRB)/ Independent Ethics committee (IEC) approved written informed consent. Patients 12 to 17 years of age inclusive must have provided IRB/IEC approved written assent; this written assent must be accompanied by an IRB/IEC approved written informed consent from the patientâ??s legally acceptable representative (i.e., parent or guardian). In addition, all patients or their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA authorization if
- •applicable.
- •3. Patients must have greater than or equal to 25 non-inflammatory lesions (i.e., open and closed comedones)AND greater than or equal to 20 inflammatory lesions (i.e., papules and pustules) AND less than or equal to 2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face. This includes lesions on the nose, but not those involving the eyes, lips, scalp, back, chest or arm.
- •4. Patients must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigatorâ??s Global Assessment(IGA) scale.
- •5. Patients must be willing to refrain from using all other topical acne medications or
- •antibiotics during the 10-week treatment period, other than the Investigational Product.
- •6. Female patients of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 1 year), in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug.
- •Note: For the purpose of this study the following are considered acceptable methods of birth control: oral or injectable contraceptives, contraceptive patches, Depo-Provera® (stabilized for at least 3 months) NuvaRing® (vaginal contraceptive); Implanon• (contraceptive implant) double barrier methods (e.g. condom and spermicide or diaphragm with spermicide), IUD, or abstinence with a 2nd acceptable method of birth control should the patient become sexually active. A sterile sexual partner is NOT considered an adequate form of birth control. Tubal ligation is not considered equivalent to female sterilization (i.e., hysterectomy). Women with a history of tubal ligation are still considered females of childbearing potential and must use birth control, as noted above.
排除标准
- •1. Female patients who are pregnant, nursing or planning to become pregnant during study
- •participation.
- •2. Patients with a history of hypersensitivity or allergy to benzoyl peroxide, clindamycin,
- •retinoids, lincomycin and/or any of the study medication ingredients.
- •3. Patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.
- •4. Patients with the 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, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
- •5. Patients with excessive facial hair (e.g. beards, sideburns, mustaches, etc.) that would
- •interfere with diagnosis or assessment of acne vulgaris.
- •6. Patients who have performed wax depilation of the face within 14 days prior to Baseline.
- •7. Patients who have used within 6 months prior to Baseline or use during the study of oral retinoids (e.g. Accutane®) or therapeutic Vitamin A supplements of greater than 10,000 units/day.
- •Note: Multivitamins are allowed.
- •8. Patients who have used estrogens or oral contraceptives for less than 3 months prior to
- •Baseline; use of such therapy must remain constant throughout the study.
- •9. Patients who have used any of the following procedures on the face within 1 month prior to Baseline or use during the study:
- •a. cryodestruction or chemodestruction,
- •b. dermabrasion/micro dermabrasion,
- •c. photodynamic therapy,
- •d. acne surgery,
- •e. intralesional steroids, or
- •f. X-ray therapy
- •10. Patients who have used any of the following treatments within 1 month prior to Baseline or during the study:
- •a. spironolactone,
- •b. systemic steroids,
- •c. systemic antibiotics,
- •d. systemic treatment for acne vulgaris (other than oral retinoids, which require a 6- month washout), or
- •e. systemic anti-inflammatory agents. If the patient uses a systemic anti-inflammatory
- •product during the study, the Principal Investigator will judge if this protocol
- •violation is clinically significant.
- •11. Patients who have used any of the following treatments within 2 weeks prior to Baseline or during the study:
- •a. topical steroids,
- •b. topical retinoids,
- •c. topical acne treatments including over-the-counter preparations
- •d. topical anti-inflammatory agents,
- •e. medicated cleansers, or
- •f. topical antibiotics.
研究者
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