A 4-Day, Randomized Study to Evaluate the Potential of MC2-01 Cream to Induce a Phototoxicity 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
- 35
- 试验地点
- 1
- 主要终点
- Within-subject Comparison and Evaluator Rating of Possible Dermal Reactions (Erythema, Edema and Other Signs of Cutaneous Irritation), 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 4-day, randomized study to determine the phototoxic potential of MC2-01 Cream when topical application to healthy skin is followed by light exposure.
详细描述
This study evaluates the potential of MC2-01 (CAL/BDP 0.005/0.042w/w%) Cream to cause a phototoxic reaction using a controlled photopatch test design. Because MC2-01 Cream is formulated for topical use and have shown to absorb light, it is necessary to determine the potential of this product to cause a phototoxic reaction after topical application and irradiation of 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)
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 of 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 non-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
研究组 & 干预措施
MC2-01 Cream, irradiation
One applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation
干预措施: MC2-01 Cream, irradiation (Drug)
MC2-01 Cream, no irradiation
One application of MC2-01 Cream (CAL/BDP, 0.005%/0.064%), no irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation
干预措施: MC2-01 Cream, no irradiation (Drug)
MC2-01 vehicle, irradiation
One application of MC2-01 vehicle, followed by irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation
干预措施: MC2-01 vehicle, irradiation (Drug)
MC2-01 vehicle, no irradiation
One application of MC2-01 vehicle, no irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation
干预措施: MC2-01 vehicle, no irradiation (Drug)
Control, irradiation
Untreated, irradiated site. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation
干预措施: Control, irradiation (Drug)
结局指标
主要结局
Within-subject Comparison and Evaluator Rating of Possible Dermal Reactions (Erythema, Edema and Other Signs of Cutaneous Irritation), After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation
时间窗: 48h post-irradiation
MC2-01 Cream, MC2-01 vehicle will be applied each to two sites. One further site will function as control site and will remain untreated. 24 hours after product application, the test sites, including the untreated control site will be evaluated for cutaneous reaction. One set of MC2-01 and MC2-01 vehicle + the untreated control site will be designated for irradiation and the other set will remain non-irradiated. Possible changes in dermal reactions (erythema, edema and other signs of cutaneous irritation) at the 5 test sites, 24 and 48 hours post-irradiation is the outcome measure of the study
次要结局
未报告次要终点