Evaluation of Potential Development of Photoallergic Skin Reaction After Use of MC2-01 Cream

Phase 1

Completed

Conditions: Photoallergy

Registration Number: NCT03899064

Lead Sponsor: MC2 Therapeutics

Brief 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.

Detailed Description: The study evaluates the potential of MC2-01(CAL/BDP 0.005/0.064 w/w%) Cream to induce a photoallergic skin reaction. Because MC2-01 Cream is formulated for topical use and has shown to absorb light within the range of natural sunlight, it is necessary to determine the potential of this product to cause a photoallergic reaction after application to the skin.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 58

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Within-subject Comparison of Dermal Reaction by the Overall Numeric Rating of Erythema and Edema at 5 Defined Test Sites, After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation.	72 hours	After an induction phase, where subjects were treated with MC2-01 Cream, MC2-01 vehicle and irradiation, the challenge phase was initiated. MC2-01 Cream and MC2-01 vehicle was applied to each two naive test sites. Another two naive test sites were untreated. 24 hours of product application, one of each test site (MC2-01 Cream, MC2-01 vehicle and untreated) were irradiated. Possible changes in dermal reaction (erythema and edema) was evaluated at all 6 test sites, 24, 48 and 72 hours post-irradiation and these evaluations are the outcome measure of the study. The following visual scores was used to express the response observed at each timepoints: Erythema: 0-3 where 0 represents no reaction and 3 represents marked/severe erythema. Edema: 0-2 where 0 represents no reaction and 2 represents definite edema with erosion/vesiculation. The diagnosis of photosensitization response will be made by the investigator based on review of the scored skin responses of both erythema and edema.

Secondary Outcome Measures