Evaluation of Potential Development of Photoallergic Skin Reaction After Use of MC2-01 Cream
Condition: Photoallergy
MeSH terms: Dermatitis, Photoallergic
Intervention: Induction: Application of MC2-01 Cream, irradiation; Induction: Application of MC2-01 Cream, no irradiation; Induction: Applications of MC2-01 vehicle, irradiation; Induction: Applications of MC2-01 vehicle, no irradiation; Challenge: Application of MC2-01 Cream, irradiation; Challenge: Application of MC2-01 Cream, no irradiation; Challenge: Applications of MC2-01 vehicle, irradiation; Challenge: Applications of MC2-01 vehicle, no irradiation; Challenge: Control, irradiation
Intervention description: Repeated applications of MC2-01 Cream (CAL/BDP, 0.005%/0.064%), 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; Repeated applications 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; Repeated applications 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; Repeated applications 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; Single application of MC2-01 Cream (CAL/BDP, 0.005%/0.064%), followed by irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema; Single 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 and edema; Single application of MC2-01 vehicle, followed by irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema; Single application of MC2-01 vehicle, no irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema; No application, but irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study consist of an Induction phase, where treatments (MC2-01 Cream, MC2-01 vehicle) were applied to 2 test sites each (n=4), followed by irradiation/non-irradiation and evaluation 24, 48 or 72 hours post-irradiation. This was repeated in total 6 times over an 3 weeks period. The induction phase was followed by a challenge phase, where treatments (MC2-01 Cream, MC2-01 vehicle) were applied to each two naive test sites and another naive test site was untreated. 24 hours of product application, one of each test sites (MC2-01 Cream, MC2-01 vehicle) + the untreated test site were irradiated. Possible changes in dermal reaction (erythema and edema) was evaluated at all 5 test sites, 24, 48 and 72 hours post-irradiation.
Masking: Double (Participant, Outcomes Assessor)
Masking description: The tests sites (M2-01 Cream, MC2-01 vehicle, control) will not be blinded to the site staff involved in the preparation/application and removal of treatments. The subjects and the trained assessor will be blinded to the IPs and treatment allocation
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This trial is a 6-week, Randomized study evaluating the potential of MC2-01 Cream to induce a
      photoallergic skin reaction in Healthy subjects, using a controlled photopatch test design.
    

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 or 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 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