evaluation of potential phototoxicity skin reaction after use of mc2-01 cream

Conditions: Phototoxicity

Summary: 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