Dermal Safety Study of GSK2585823 (Clindamycin 1%-Benzoyl Peroxide 3% Gel) With Healthy Japanese Male and Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Photo allergy and toxicity (Photo patch test)
研究概览
简要总结
This is a randomized, single-center, partial-blind study to evaluate the dermal irritation potential and to detect photo-toxicity and photo-allergy potential of GSK2585823, Benzoyl peroxide BPO 5% gel, Benzoyl peroxide 3% gel, vehicle gel and negative control (distilled water) applied using Finn-Chambers® by single and 7-day repeat patch test in 20 Japanese healthy male and female volunteers. Finn-Chambers containing no investigational product will be applied in the same manner.
Safety will also be assessed by measurement of vital signs, electrocardiograms, safety laboratory data and review of adverse events.
详细描述
Each subjects will be applied the adequate amount of GSK2585823, Benzoyl peroxide 3%, Benzoyl peroxide 5%, placebo (Vehicle) and negative control (distilled water) using Finn Chambers on Scanpor (the tape for the patch test which Finn Chamber® put on the Scanpor® tape in advance) on their upper back at same time for the simple patch test and the photo patch test. The empty Finn Chamber® will also be applied at the same time. The position of application for each product (including empty Finn Chamber®) will be randomized The position of application for each subjects will be same for the simple patch test and the photo patch test.
For the simple patch test, dermal condition will be assessed up to 48 hours after removal of the Finn-Chambers®. After removing the Finn-Chambers®, the skin areas will be gently wiped with wet absorbent cotton before the first evaluation at 30 minutes.
For the photo patch test, two sets of Finn-Chambers® will be applied to the skin. Twenty-four hours after the single application or the last application of the repeat dosing, a set of Finn-Chambers® will be removed. The skin areas will be gently wiped and exposed to 6.0 J/cm2 of ultraviolet A. The other set of Finn-Chambers® are covered to avoid ultraviolet A exposure to serve as un-irradiated control when photo-allergy is assessed 30 minutes after ultraviolet A exposure. After the assessment, the skin areas will be covered with empty Finn-Chambers® for additional 24 hours to prevent further exposure to light. Photo-toxicity will be assessed 24 and 48 hours after the ultraviolet A exposure.
Assessment of Simple Patch test
- The dermatologist will examine the planned application sites and skin reactions at the application sites, and make assessments at the following time points according to the criteria proposed by the patch test study group in Japan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy as determined by a responsible and experienced physician.
- •Japanese healthy male and female subjects aged between 20 and 45 years of age inclusive, at the time of signing the informed consent.
- •Asparate aminotransferase(AST), Alanine aminotransferase(ALT) and total bilirubin < Upper level of normal range
- •Non-smoker (never smoked or not smoking for >6 months with <10 pack years history (Pack years = (cigarettes per day smoked/20) x number of years smoked)).
- •Body Mass Index (BMI) within the range =>18.5 to < 25.0 kg/m2 at screening
- •A female subject is eligible to participate if she is of:
- •Non-childbearing potential.
- •Child-bearing potential and agrees to use one of the contraception methods from screening to the follow up examination.
- •Capable of giving written informed consent.
- •Single QTcB < 450 msec at screening
排除标准
- •A positive test for syphilis, Hepatitis B surface antigen or positive Hepatitis C antibody, HIV antibody and HTLV-1 result at screening.
- •A positive for urine drug screening.
- •History of regular alcohol consumption within 6 months of the study defined as:
- •an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 g of alcohol: 350 mL of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
- •The subject has participated in a clinical study with an investigational or a non-investigational drug or device during the previous 4 months.
- •The subject planned to concurrently participate in another clinical study or post-marketing study.
- •Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days prior to the first application of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- •History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- •The subject has donated a unit of blood ">400 mL" within the previous 4 months or ">200 mL" within the previous 1 month.
- •Pregnant females as determined by positive urine hCG test at screening or prior to dosing.
- •Lactating females.
- •Unwillingness or inability to follow the procedures outlined in the protocol.
- •Subject is mentally or legally incapacitated.
- •Subjects with clinically significant skin diseases which may contraindicate participation, or interfere with test site evaluations, including psoriasis, eczema, atopic dermatitis, acne, dysplastic nevi, or other skin pathologies.
- •Subjects with a history of hypersensitivity or idiosyncratic reaction to benzoyl peroxide, clindamycin, lincomycin or any study medication components or requiring significant concomitant medications or with diseases affecting evaluation of study medication
- •Subjects with scars, moles, other blemishes or tattoos, darkened skin or excessive hair on the utilised area of the mid or upper back which would interfere with grading the test sites
- •Within six months (oral) or 2 weeks (topical) prior to and during the study, subjects must not be treated with retinoids.
- •For one month (systemic) or 2 weeks (topical) before and during the study, subjects not to be treated with corticosteroids or any other medication that could interfere with study results.
- •Subjects with sunburn or suntan on test area of mid or upper back
- •Subjects with considerable exposure to sunlight, including sunlamps, on test area of mid or upper back
- •Subjects with inherent sensitivity to sun or history of photosensitivity
研究组 & 干预措施
GSK2585823
external preparation
干预措施: GSK2585823 (Drug)
Benzoic peroxide 3%
external preparation
干预措施: Benzoyl peroxide 3% (Drug)
Benzoic peroxide 5%
external preparation
干预措施: Benzoyl peroxide 5% (Drug)
Vehicle
external preparation
干预措施: Vehicle (Other)
结局指标
主要结局
Photo allergy and toxicity (Photo patch test)
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 22 days.
Dermal irritancy (simple patch test)
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 22 days.
次要结局
- Photo-toxicity and photo-allergy potential (photo-patch test)(Participants will be followed for the duration of hospital stay, an expected average of 22 days.)
- Safety and tolerability endpoints: adverse events, blood pressure, heart rate, 12-lead ECG, clinical laboratory safety tests(Participants will be followed for the duration of hospital stay, an expected average of 22 days.)