A Randomised, Double-blind, Multicentre, Parallel-group, Active and Placebo Controlled, Three Arm Clinical Study to Compare the Efficacy and Safety of Clindamycin Phosphate 10 mg/g and Benzoyl Peroxide 50 mg/g Gel (Morningside Healthcare Ltd, UK) versus DUAC Once Daily 10 mg/g and 50 mg/g Gel (GlaxoSmithKline UK Limited) in Subjects with Acne Vulgaris.

Morningside Healthcare Ltd21 个研究点分布在 1 个国家目标入组 530 人开始时间: 2018年5月9日最近更新: 2020年10月1日

试验速览

阶段: 不适用
状态: 已完成
发起方: Morningside Healthcare Ltd
入组人数: 530
试验地点: 21
主要终点: Primary Efficacy Endpoint-

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A Randomised, Double-blind, Multicentre, Parallel-group, Active & Placebo Controlled, Three Arm Clinical Study to Compare the Efficacy and Safety of Clindamycin Phosphate 10 mg/g and Benzoyl Peroxide 50 mg/g Gel (Morningside Healthcare Ltd, UK) versus DUACÂ® Once Daily 10 mg/g and 50 mg/g Gel (GlaxoSmithKline UK Limited) in Subjects with Acne Vulgaris.

530 subjects will be required to be enrolled (randomised) in the study for around 91 days that includes screening period of 14 days and treatment period of 11 weeks.

The end of the study will be the date of the last study visit for the last subject in the study.

The study will commence only after the approval from the Local Regulatory Approval (DCGI).

The maximum estimated period for each subject on study is anticipated to be approximately 11 weeks.

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 more than or equal to 12 and less than or equal to 40 years with a clinical diagnosis of Acne vulgaris.
•On the face, more than or equal to 25 non-inflammatory lesions (i.e., open and closed comedones) AND more than or equal to 20 inflammatory lesions (i.e., papules and pustules) AND less than or equal to 2 nodules.
•Investigatorâ€™s Global Assessment (IGA) of acne severity grade 2, 3 or
•Willing to refrain from use of all other topical acne medications or antibiotics during the 11 week treatment period.
•If female of childbearing potential, willing to use an acceptable form of birth control during the study.
•Willing to provide written informed consent or assent, as applicable.

排除标准

•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).
•Subjects who have acne conglobata, acne fulminans, nodulocystic acne and secondary acne (e.g. chloracne and drug induced acne).
•Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
•Well-trimmed moustaches are allowed.
•History of hypersensitivity or allergy to clindamycin or lincomycin or benzoyl peroxide and/or any of the study medication ingredients.
•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 per day (multivitamins are allowed).
•Use for less than 3 months prior to baseline (Randomisation) of estrogens or oral contraceptives; use of such therapy is allowed if it will remain constant throughout the study.
•Use on the face within 1 month prior to baseline (Randomisation) of 1) cryodestruction or chemodestruction, 2) dermabrasion / microdermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, 6) X-ray therapy, or 7) chemical or laser peel.
•Use within 1 month prior to baseline (Randomisation) of 1) spironolactone, 2) systemic steroids, 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.
•Use within 2 weeks prior to baseline (Randomisation) of 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, 5) medicated cleansers/shampoo or 6) topical antibiotics.
•Subjects who have received neuromuscular blocking agents within 14 days prior to study entry (Randomisation).
•Used astringents and toners for less than 2 weeks prior to the start of the study.
•Used 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 Î±- or Î²-hydroxy acids within the previous 2 weeks.
•Concomitant use/planned to use of mega-doses of certain vitamins (such as mega-doses of vitamin D [more than 2000 IU per day], vitamin B6 [more than 2 mg] or vitamin B12 [more than 1 mg per day]), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
•Use of tanning booths or tanning lamps within 1 week prior to Baseline and an unwillingness to refrain from use during the study.
•A significant medical history of or are currently immunocompromised or receiving immunomodulators/biologics since last 3 months.
•Have a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.
•Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.
•Subjects who engage in activities that involve excessive or prolonged exposure to sunlight.
•Current drug or alcohol abuse.
•Lived in the same household as currently enrolled subjects.
•Female subjects who are breast-feeding or planning to become pregnant.
•Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study enrolment.
•Clinically significant abnormal findings or condition (other than acne), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.