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

A 4-Day, Randomized Study to Evaluate the Potential of MC2-01 Cream to Induce a Phototoxicity Skin Reaction in Healthy Subjects, Using a Controlled Photopatch Test Design

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.

Study Overview

• Status: Completed
• Conditions: Phototoxicity
• Intervention / Treatment: Drug: MC2-01 Cream, irradiation; Drug: MC2-01 Cream, no irradiation; Drug: MC2-01 vehicle, irradiation; Drug: MC2-01 vehicle, no irradiation; Drug: Control, irradiation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Fair Lawn, New Jersey, United States, 07410
      • TKL Research Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MC2-01 Cream, irradiation; One applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream, followed by irradiation	Drug: MC2-01 Cream, irradiation; One application of MC2-01 Cream, 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
EXPERIMENTAL: MC2-01 Cream, no irradiation; 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	Drug: MC2-01 Cream, no irradiation; One application of MC2-01 Cream. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation
EXPERIMENTAL: MC2-01 vehicle, irradiation; 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	Drug: MC2-01 vehicle, irradiation; 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
EXPERIMENTAL: MC2-01 vehicle, no irradiation; 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	Drug: MC2-01 vehicle, no irradiation; One application of MC2-01 vehicle. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation
EXPERIMENTAL: Control, irradiation; 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	Drug: Control, irradiation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Within-subject Comparison and Evaluator Rating of Possible Dermal Reactions (Erythema, Edema and Other Signs of Cutaneous Irritation), After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation	MC2-01 Cream, MC2-01 vehicle will be applied each to two sites. One further site will function as control site and will remain untreated. 24 hours after product application, the test sites, including the untreated control site will be evaluated for cutaneous reaction. One set of MC2-01 and MC2-01 vehicle + the untreated control site will be designated for irradiation and the other set will remain non-irradiated. Possible changes in dermal reactions (erythema, edema and other signs of cutaneous irritation) at the 5 test sites, 24 and 48 hours post-irradiation is the outcome measure of the study	Baseline, before irradiation
Within-subject Comparison and Evaluator Rating of Possible Dermal Reactions (Erythema, Edema and Other Signs of Cutaneous Irritation), After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation	MC2-01 Cream, MC2-01 vehicle will be applied each to two sites. One further site will function as control site and will remain untreated. 24 hours after product application, the test sites, including the untreated control site will be evaluated for cutaneous reaction. One set of MC2-01 and MC2-01 vehicle + the untreated control site will be designated for irradiation and the other set will remain non-irradiated. Possible changes in dermal reactions (erythema, edema and other signs of cutaneous irritation) at the 5 test sites, 24 and 48 hours post-irradiation is the outcome measure of the study	24h post-irradiation
Within-subject Comparison and Evaluator Rating of Possible Dermal Reactions (Erythema, Edema and Other Signs of Cutaneous Irritation), After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation	MC2-01 Cream, MC2-01 vehicle will be applied each to two sites. One further site will function as control site and will remain untreated. 24 hours after product application, the test sites, including the untreated control site will be evaluated for cutaneous reaction. One set of MC2-01 and MC2-01 vehicle + the untreated control site will be designated for irradiation and the other set will remain non-irradiated. Possible changes in dermal reactions (erythema, edema and other signs of cutaneous irritation) at the 5 test sites, 24 and 48 hours post-irradiation is the outcome measure of the study	48h post-irradiation

Collaborators and Investigators

• Sponsor: MC2 Therapeutics
• Investigators: Principal Investigator: Jonathan S Dorsik, TKL Research, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 27, 2019
• Primary Completion (ACTUAL): March 9, 2019
• Study Completion (ACTUAL): March 9, 2019

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (ACTUAL): March 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Dermatitis, Irritant; Dermatitis, Contact; Photosensitivity Disorders; Dermatitis, Phototoxic
• Other Study ID Numbers: MC2-01-C9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Single site study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No