Evaluation of Potential Phototoxicity Skin Reaction After Use of MC2-01 Cream

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Phototoxicity

Intervention / Treatment
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* Drug: MC2-01 Cream, irradiation
* Drug: MC2-01 Cream, no irradiation
* Drug: MC2-01 vehicle, irradiation
* Drug: MC2-01 vehicle, no irradiation
* Drug: Control, irradiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One treatment with MC2-01 Cream, MC2-01 vehicle and control on defined applications site (N=5), followed by irradiation/non-irradiation and evaluation 24 or 48 hours post irradiation, within subject comparison model
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MC2-01 Cream, irradiation<br>One applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation | Drug: MC2-01 Cream, irradiation<br>* One application of MC2-01 Cream, 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<br>|
| Experimental: MC2-01 Cream, no irradiation<br>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 | Drug: MC2-01 Cream, no irradiation<br>* One application of MC2-01 Cream. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation<br>|
| Experimental: MC2-01 vehicle, irradiation<br>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 | Drug: MC2-01 vehicle, irradiation<br>* 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<br>|
| Experimental: MC2-01 vehicle, no irradiation<br>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 | Drug: MC2-01 vehicle, no irradiation<br>* One application of MC2-01 vehicle. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation<br>|
| Experimental: Control, irradiation<br>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 | Drug: Control, irradiation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Baseline, before irradiation | 
| 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 | 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 | 24h post-irradiation | 
| 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 | 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 | 48h post-irradiation |