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

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.

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.

Eligibility Criteria:
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