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

A 6-Week, Randomized Study to Evaluate the Potential of MC2-01 Cream to Induce Photoallergic Skin Reaction in Healthy Subjects, Using a Controlled Photopatch Test Design

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.

Study Overview

• Status: Completed
• Conditions: Photoallergy
• Intervention / Treatment: Drug: Induction: Application of MC2-01 Cream, irradiation; Drug: Induction: Application of MC2-01 Cream, no irradiation; Drug: Induction: Applications of MC2-01 vehicle, irradiation; Drug: Induction: Applications of MC2-01 vehicle, no irradiation; Drug: Challenge: Application of MC2-01 Cream, irradiation; Drug: Challenge: Application of MC2-01 Cream, no irradiation; Drug: Challenge: Applications of MC2-01 vehicle, irradiation; Drug: Challenge: Applications of MC2-01 vehicle, no irradiation; Drug: Challenge: Control, irradiation

Detailed Description

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
• Enrollment (Actual): 58
• 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: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Induction:MC2-01 Cream, irradiation; Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation	Drug: Induction: Application of MC2-01 Cream, irradiation; 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
Experimental: Induction: MC2-01 Cream, no irradiation; Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation	Drug: Induction: Application of MC2-01 Cream, no irradiation; 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
Experimental: Induction: MC2-01 vehicle, irradiation; Applications with MC2-01 vehicle, followed by irradiation	Drug: Induction: Applications of MC2-01 vehicle, irradiation; Repeated applications 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: Induction: MC2-01 vehicle, no irradiation; Applications with MC2-01 vehicle, no irradiation	Drug: Induction: Applications of MC2-01 vehicle, no irradiation; Repeated applications 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
Experimental: Challenge: MC2-01 Cream, irradiation; Application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation	Drug: Challenge: Application of MC2-01 Cream, irradiation; Single application 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 and edema
Experimental: Challenge: MC2-01 Cream, No irradiation; Application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation	Drug: Challenge: Application of MC2-01 Cream, no irradiation; Single 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 and edema
Experimental: Challenge: MC2-01 vehicle, irradiation; Application with MC2-01 vehicle, followed by irradiation	Drug: Challenge: Applications of MC2-01 vehicle, irradiation; Single application of MC2-01 vehicle, followed by irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema
Experimental: Challenge: MC2-01 vehicle, no irradiation; Application with MC2-01 vehicle, no irradiation	Drug: Challenge: Applications of MC2-01 vehicle, no irradiation; Single application of MC2-01 vehicle, no irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema
Experimental: Challenge: Control, irradiation; No application, but irradiation	Drug: Challenge: Control, irradiation; No application, but irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours
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 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.	48 hours
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 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.	72 hours

Collaborators and Investigators

• Sponsor: MC2 Therapeutics
• Investigators: Principal Investigator: Jonathan S Dosik, MD, TKL Research

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2019
• Primary Completion (Actual): April 5, 2019
• Study Completion (Actual): April 5, 2019

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (Actual): April 2, 2019

Study Record Updates

• Last Update Posted (Actual): March 11, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Dermatitis, Contact; Photosensitivity Disorders; Dermatitis, Allergic Contact; Dermatitis, Photoallergic
• Other Study ID Numbers: MC2-01-C10

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