A 6-Week, Randomized Study to Evaluate the Potential of CCP-020 (Diacerein 1%) Topical Ointment to Induce a Photoallergic Skin Reaction in Healthy Subjects, Using a Controlled Photopatch Test Design
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score
研究概览
简要总结
A study in healthy male and female adult volunteers to determine the potential of diacerein 1% ointment to induce a photoallergic skin reaction using a controlled photopatch testing procedure.
详细描述
This was a randomized, single center, vehicle controlled, within-subject comparison study of diacerein 1% ointment and vehicle ointment applied under fully occlusive patch conditions on the infrascapular region of each subject's back to induce a photoallergic skin reaction following Ultraviolet (UV) irradiation. This was repeated twice each week during the 3-week Induction Phase, once during rest week 4 as applicable and once at Challenge Phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is a healthy male or female (to be confirmed by medical history);
- •Is 18 years of age or older;
- •In the case of a female of childbearing potential, is using an acceptable form of birth control;
- •In the case of a female of childbearing potential, has a negative urine pregnancy test (UPT) at Day 1 and are willing to submit to a UPT at the end of study (EOS);
- •Is free of any systemic or dermatological disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs;
- •Is of any Fitzpatrick Skin Type or race, providing the skin pigmentation will allow discernment of erythema
排除标准
- •Has a history of photosensitivity or photoallergy;
- •Is using systemic/topical corticosteroids within 3 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study;
- •Is not willing to refrain from using systemic/topical anti-inflammatory analgesics such as aspirin, (occasional use of acetaminophen will be permitted);
- •Are taking medication known to cause phototoxic reactions (eg, tetracyclines, thiazides, nonsteroidal anti-inflammatory drugs [NSAIDS]);
- •Is using medication which, in the opinion of the Investigator, will interfere with the study results;
- •Is unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study;
- •Has psoriasis and/or active atopic dermatitis/eczema;
- •Had a known sensitivity or allergy to constituents of the materials being evaluated including diacerein, mineral oil, petrolatum, cetyl alcohol, D&C Yellow #10 and/or ethyl paraben;
- •Has damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;
- •Has received treatment for any type of internal cancer within 5 years prior to study entry;
- •Has any known sensitivity to adhesives; and/or
- •Has received any investigational drugs(s) with 4 weeks prior to study entry
研究组 & 干预措施
Single Cohort (Healthy Volunteers)
Diacerein 1% topical ointment Intra-subject photoallergy (photosensitization) test
干预措施: Diacerein 1% ointment (Drug)
结局指标
主要结局
Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score
时间窗: Skin sites evaluated 24, 48, and 72 hours after patch removal and irradiation challenge
The determination of photosensitization reactions was summarized by frequency counts of the total dermal irritation score during the Challenge Phase. Total Irritation Score is a visual score summing the degree of erythema and edema. Minimum score=0, maximum score=5; higher score=worse outcome
次要结局
未报告次要终点