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

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.

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