CTRI/2020/11/028801已完成不适用
A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% (Cadila Pharmaceuticals Limited) to Epiduo® Forte (Adapalene and Benzoyl Peroxide) Gel, 0.3%/2.5%, Galderma Laboratories, L.P.) And both active treatments to a placebo control in the treatment of acne vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 11
- 主要终点
- Percent change in the inflammatory and non-inflammatory lesion counts.
研究概览
简要总结
In this randomized, double-blind, placebo controlled, parallel-group, multiple-center study of 12 weeks per subject, 500 subjects with acne vulgaris will be randomly assigned in a 2:2:1 allocation ratio to treatment with the test product, reference product or placebo control, respectively.
The objective is to evaluate the therapeutic equivalence and safety of Test product and comparator product in the treatment of acne vulgaris.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
- •Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent.
- •Subjects 12 to 17 years of age.inclusive must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject’s legally acceptable representative (i.e., parent or guardian).
- •In addition, all Subjects or their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA authorization, if applicable.
- •Subjects must have ≥ 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), at baseline on the face.
- •For the purposes of study treatment and evaluation, these lesions will be limited to the facial treatment area.
- •All lesions will be counted, including those present on the nose.
- •Lesions involving the eyes, lips and scalp should be excluded from the count.
- •Subjects may have acne lesions on other areas of the body which will also be excluded from the count, treatment, and the Investigator’s Global Assessment (IGA) evaluation (e.g., on the back, chest and arms).
- •Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator’s Global Assessment (IGA).
- •Subjects must be willing to refrain from using all other topical acne medications or antibiotics for acne vulgaris during the 12-week treatment period, other than the investigational product.
- •Female Subjects of childbearing potential (excluding women who are or premenarchal, 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.
- •A sterile sexual partner is NOT considered an adequate form of birth control.
- •All male Subjects must agree to use accepted methods of birth control with their partners.
- •Female partners should use an acceptable method of birth control.
- •Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
- •Subjects must be in good health and free from any clinically significant disease, including but not limited to, conditions that may interfere with the evaluation of acne vulgaris.
- •Subjects who use make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to not change make-up brand/type or frequency of use throughout the study.
排除标准
- •Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- •Subjects with a history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients, have a known hypersensitivity to adapalene and benzoyl peroxide and its excipients.
- •Subjects 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).
- •Subjects with excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
- •Subjects who have performed wax depilation of the face within 14 days prior to baseline.
- •Subjects who have used within 6 months prior to baseline or use during the study of oral retinoids or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
- •Subjects 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.
- •Subjects who have used procedures such as cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, or f.
- •X-ray therapy on the face within 1 month prior to baseline or use during the study.
- •Subjects who have used treatments within 1 month prior to baseline or during the study: such as systemic steroids, systemic antibiotics, systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or systemic anti-inflammatory agents.
- •If Subject uses a systemic anti-inflammatory product during the study, the Principal Investigator will judge if this protocol violation is clinically significant, :
- •Subjects who have used treatments such as topical steroids,topical retinoids, topical acne treatments including over-the-counter preparations, topical anti-inflammatory agents, or topical antibiotics within 2 weeks prior to baseline or during the study.
- •Subjects who have received radiation therapy and/or anti-neoplastic agents within 90 days prior to baseline.
- •Subjects who have unstable medical disorders that are clinically significant or have life threatening diseases.
- •Subjects who have on-going malignancies requiring systemic treatment will be excluded from study participation.
- •In addition, Subjects who have any malignancy of the skin of the facial area will also be excluded.
- •Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.
- •Subjects who consume excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to, cannabinoids, cocaine and barbiturates).
- •Subjects who have participated in an investigational drug study (i.e., Subjects have been treated with an investigational drug) within 30 days prior to baseline will be excluded from study participation.
- •Subjects who are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion.
- •Subjects who have been previously enrolled in this study.
- •Subjects who have had laser therapy, electrodessication and phototherapy to the facial area within 180 days prior to study entry.
- •Subjects who have had cosmetic procedures (e.g., facials) which may affect the efficacy and safety profile of the investigational product within 14 days prior to study entry.
- •Cosmetic procedures and facials are prohibited throughout the study
- •Subjects who currently have or have recently had bacterial folliculitis on the face.
- •Subjects with a baseline irritation score of 3 (severe, marked/intense) for erythema, dryness, burning/stinging, erosion, edema, pain and itching will not be enrolled.
结局指标
主要结局
Percent change in the inflammatory and non-inflammatory lesion counts.
时间窗: From baseline to week 12.
次要结局
- Success or Failure for clinical response (based on IGA score).(At week 12 from randomization.)
研究者
研究点 (11)
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