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

• Status: Completed
• Trial end date: 2019-04-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Drug Delivery Solutions Ltd. (part of MC2 Therapeutics); MC2 Therapeutics
• Treatments: Betamethasone-17,21-dipropionate

Criteria

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