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

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ClinicalTrials.gov Identifier: NCT03899064
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
MC2 Therapeutics

Brief 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.

Condition or disease Intervention/treatment Phase
Photoallergy Drug: Application of MC2-01 Cream, irradiation Drug: Application of MC2-01 Cream Drug: Applications of MC2-01 vehicle, irradiation Drug: Applications ofh MC2-01 vehicle Drug: Control, irradiation Drug: Control Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Repeatedly (Induction and Challenge phases) treatments with MC2-01 Cream, MC2-01 vehicle and control on defined applications sites (n=6), followed by irradiation/non-irradiation and evaluation 24, 48 or 72 hours post-irradiation, within-subject comparison model
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The treatment sites (M2-01 Cream, MC2-01 vehicle, control) will not be blinded to the site staff involved in the preparation/application and removal of treatments. The subjects and the trained assessor will be blinded to the IPs and treatment allocation
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 13, 2019
Actual Primary Completion Date : April 5, 2019
Actual Study Completion Date : April 5, 2019

Arm Intervention/treatment
Experimental: MC2-01 Cream, irradiation
Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation
Drug: 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: MC2-01 Cream, No irradiation
Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%)
Drug: Application of MC2-01 Cream
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: MC2-01 vehicle, irradiation
Applications with MC2-01 vehicle, followed by irradiation
Drug: 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: MC2-01 vehicle, no irradiation
Applications with MC2-01 vehicle
Drug: Applications ofh MC2-01 vehicle
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: Control, Irradiation
No applications, but irradiation
Drug: Control, irradiation
No application but irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation

Experimental: Control, no irradiation
No applications and no irradiation
Drug: Control
No application, no irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation




Primary Outcome Measures :
  1. Within-subject comparison of dermal reaction by the overall numeric rating of erythema and edema at 6 defined test sites, after application of MC2-01 Cream, MC2-01 vehicle or untreated at 2 defined test sites each, followed by irradiation [ Time Frame: 24 hours, 48 hours and 72 hours after the application ]
    MC2-01 Cream, MC2-01 vehicle will be applied to each two sites and another two sites will be untreated. 24 hours of product application, one of each site (MC2-01 Cream, MC2-01 vehicle or untreated) will be irradiated. This will be repeated during an induction phase and a challenge phase. Possible changes in dermal reaction (erythema and edema) at the 6 test sites, 24, 48 and 72 hours post-irradiation is the outcome measure of the study. The following visual scores will be 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899064


Locations
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United States, New Jersey
TKL Research Inc.
Fair Lawn, New Jersey, United States, 07410
Sponsors and Collaborators
MC2 Therapeutics
Investigators
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Principal Investigator: Jonathan S Dosik, MD TKL Research

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Responsible Party: MC2 Therapeutics
ClinicalTrials.gov Identifier: NCT03899064     History of Changes
Other Study ID Numbers: MC2-01-C10
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Single site study

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dermatitis, Photoallergic
Dermatitis, Allergic Contact
Dermatitis, Contact
Dermatitis
Skin Diseases
Photosensitivity Disorders
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases
Betamethasone-17,21-dipropionate
Anti-Inflammatory Agents