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

MC2 Therapeutics58 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Photoallergy

Interventions

Induction: Application of MC2-01 Cream, irradiationDRUG

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

Induction: Application of MC2-01 Cream, no irradiationDRUG

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

Induction: Applications of MC2-01 vehicle, irradiationDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

TKL Research Inc.

Fair Lawn, New Jersey, United States

Outcomes

Primary Outcomes

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.

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 naive test site was untreated. 24 hours after product application, one of each test site (MC2-01 Cream, MC2-01 vehicle) + the untreated 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 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.

Time frame: 24 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.

Time frame: 48 hours

Data from ClinicalTrials.gov

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