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

MC2 Therapeutics

Status and phase: Completed; Phase 1

Conditions: Phototoxicity

Treatments: Drug: MC2-01 vehicle, no irradiation; Drug: MC2-01 Cream, no irradiation; Drug: MC2-01 Cream, irradiation; Drug: MC2-01 vehicle, irradiation; Drug: Control, irradiation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03892564

MC2-01-C9

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 5 patient groups

MC2-01 Cream, irradiation

Experimental group

Description:

One applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation

Treatment:

Drug: MC2-01 Cream, irradiation

MC2-01 Cream, no irradiation

Experimental group

Description:

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

Treatment:

Drug: MC2-01 Cream, no irradiation

MC2-01 vehicle, irradiation

Experimental group

Description:

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

Treatment:

Drug: MC2-01 vehicle, irradiation

MC2-01 vehicle, no irradiation

Experimental group

Description:

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

Treatment:

Drug: MC2-01 vehicle, no irradiation

Control, irradiation

Experimental group

Description:

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

Treatment:

Drug: Control, irradiation