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

Phase 1

Completed

Conditions: Phototoxicity

Interventions: Drug: MC2-01 Cream, irradiation
Drug: MC2-01 vehicle, irradiation
Drug: Control, irradiation
Drug: MC2-01 Cream, no irradiation
Drug: MC2-01 vehicle, no irradiation

Registration Number: NCT03892564

Lead Sponsor: MC2 Therapeutics

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 35

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MC2-01 Cream, irradiation	MC2-01 Cream, irradiation	One applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation
MC2-01 vehicle, irradiation	MC2-01 vehicle, irradiation	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
Control, irradiation	Control, irradiation	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
MC2-01 Cream, no irradiation	MC2-01 Cream, no irradiation	One 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, edema and other signs of cutaneous irritation
MC2-01 vehicle, no irradiation	MC2-01 vehicle, no irradiation	One application 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

Primary Outcome Measures

Name	Time	Method
Within-subject Comparison and Evaluator Rating of Possible Dermal Reactions (Erythema, Edema and Other Signs of Cutaneous Irritation), After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation	48h post-irradiation	MC2-01 Cream, MC2-01 vehicle will be applied each to two sites. One further site will function as control site and will remain untreated. 24 hours after product application, the test sites, including the untreated control site will be evaluated for cutaneous reaction. One set of MC2-01 and MC2-01 vehicle + the untreated control site will be designated for irradiation and the other set will remain non-irradiated. Possible changes in dermal reactions (erythema, edema and other signs of cutaneous irritation) at the 5 test sites, 24 and 48 hours post-irradiation is the outcome measure of the study

Secondary Outcome Measures