Evaluation of Potential Phototoxicity Skin Reaction After Use of MC2-01 Cream
Condition: Phototoxicity
MeSH terms: Dermatitis, Phototoxic
Intervention: MC2-01 Cream, irradiation; MC2-01 Cream, no irradiation; MC2-01 vehicle, irradiation; MC2-01 vehicle, no irradiation; Control, irradiation
Intervention description: 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; 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; 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; 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; 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
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

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