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

Completed · Phase 1

Conditions studied: Phototoxicity

In brief

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.

Key facts

Study ID

NCT03892564

Run by

MC2 Therapeutics

People needed

35

Starts

2019-02-27

Expected to finish

2019-03-09

Last updated by the study team

2020-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• TKL Research Inc — Fair Lawn, New Jersey, United States

Full record on ClinicalTrials.gov

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