A 6-Week, Randomized Study to Evaluate the Potential of MC2-01 Cream to Induce 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
- 58
- 试验地点
- 2
- 主要终点
- Within-subject Comparison of Dermal Reaction by the Overall Numeric Rating of Erythema and Edema at 5 Defined Test Sites, After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation.
研究概览
简要总结
This trial is a 6-week, Randomized study evaluating the potential of MC2-01 Cream to induce a photoallergic skin reaction in Healthy subjects, using a controlled photopatch test design.
详细描述
The study evaluates the potential of MC2-01(CAL/BDP 0.005/0.064 w/w%) Cream to induce a photoallergic skin reaction. Because MC2-01 Cream is formulated for topical use and has shown to absorb light within the range of natural sunlight, it is necessary to determine the potential of this product to cause a photoallergic reaction after application to the skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The tests sites (M2-01 Cream, MC2-01 vehicle, control) will not be blinded to the site staff involved in the preparation/application and removal of treatments. The subjects and the trained assessor will be blinded to the IPs and treatment allocation
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
- •Is 18 years of age or older
- •Agree not to participate in any clinical or patch test studies at Day 1 through study completion
- •Females or childbearing potential must use a highly effective method of contraception for one month prior to Screening and until the end of study visit has been performed
- •In the case of a female of childbearing potential, has a negative urine pregnancy test on Day 1 prior to randomization and are willing to submit to a urine pregnancy test at the end of study
- •In the case of a female of childbearing potential, has had a hysterectomy or is postmenopausal
- •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.
- •Has uniformly-colored skin on the intrascapular region of the back which will allow discernment of erythema, and has Fitzpatrick skin types I, II or III
- •Complete a medical screening procedure
- •Read, understand and sign an informed consent
排除标准
- •Has a history of photosensitivity or photoallergy
- •Has any visible skin disease at the application site which, in the opinion of the Investigator, will interfere with the evaluation of the test site reaction
- •Current or past history of hypercalcemia, vitamin D toxicity, severe renal insufficiency or severe hepatic disorders
- •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 (81 mg aspirin and occasional use of acetaminophen will be permitted)
- •Are taking medication known to cause phototoxic reaction
- •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 atopic dermatitis/eczema
- •Has a known sensitivity or allergy to constituents of the materials being evaluated
- •Is a female who is pregnant, plans to become pregnant during the study, or is breast feeding a child
- •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 a history of, or are currently being treated for skin cancer and/or hepatitis
- •Has a history or, or is currently being treated for diabetes
- •Has any condition that might compromise study results
- •Is expected to sunbathe or use tanning salons during the study
- •Has a history of adverse response to UV-sun lamps/sunlight exposure
- •Is currently participating in any clinical testing
- •Has any known sensitivity to adhesives
- •Has received any investigational drug(s) within 28 days from Day 1
结局指标
主要结局
Within-subject Comparison of Dermal Reaction by the Overall Numeric Rating of Erythema and Edema at 5 Defined Test Sites, After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation.
时间窗: 72 hours
After an induction phase, where subjects were treated with MC2-01 Cream, MC2-01 vehicle and irradiation, the challenge phase was initiated. MC2-01 Cream and MC2-01 vehicle was applied to each two naive test sites. Another two naive test sites were untreated. 24 hours of product application, one of each test site (MC2-01 Cream, MC2-01 vehicle and untreated) were irradiated. Possible changes in dermal reaction (erythema and edema) was evaluated at all 6 test sites, 24, 48 and 72 hours post-irradiation and these evaluations are the outcome measure of the study. The following visual scores was used to express the response observed at each timepoints: Erythema: 0-3 where 0 represents no reaction and 3 represents marked/severe erythema. Edema: 0-2 where 0 represents no reaction and 2 represents definite edema with erosion/vesiculation. The diagnosis of photosensitization response will be made by the investigator based on review of the scored skin responses of both erythema and edema.
次要结局
未报告次要终点