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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-13

Study Completion Date

2019-04-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Photoallergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study consist of an Induction phase, where treatments (MC2-01 Cream, MC2-01 vehicle) were applied to 2 test sites each (n=4), followed by irradiation/non-irradiation and evaluation 24, 48 or 72 hours post-irradiation. This was repeated in total 6 times over an 3 weeks period. The induction phase was followed by a challenge phase, where treatments (MC2-01 Cream, MC2-01 vehicle) were applied to each two naive test sites and another naive test site was untreated. 24 hours of product application, one of each test sites (MC2-01 Cream, MC2-01 vehicle) + the untreated test 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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The tests 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

Study Groups

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Induction:MC2-01 Cream, irradiation

Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation

Group Type EXPERIMENTAL

Induction: Application of MC2-01 Cream, irradiation

Intervention Type DRUG

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

Induction: MC2-01 Cream, no irradiation

Applications with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation

Group Type EXPERIMENTAL

Induction: Application of MC2-01 Cream, no irradiation

Intervention Type DRUG

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

Induction: MC2-01 vehicle, irradiation

Applications with MC2-01 vehicle, followed by irradiation

Group Type EXPERIMENTAL

Induction: Applications of MC2-01 vehicle, irradiation

Intervention Type DRUG

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

Induction: MC2-01 vehicle, no irradiation

Applications with MC2-01 vehicle, no irradiation

Group Type EXPERIMENTAL

Induction: Applications of MC2-01 vehicle, no irradiation

Intervention Type DRUG

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

Challenge: MC2-01 Cream, irradiation

Application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), followed by irradiation

Group Type EXPERIMENTAL

Challenge: Application of MC2-01 Cream, irradiation

Intervention Type DRUG

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

Challenge: MC2-01 Cream, No irradiation

Application with MC2-01 Cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%), no irradiation

Group Type EXPERIMENTAL

Challenge: Application of MC2-01 Cream, no irradiation

Intervention Type DRUG

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

Challenge: MC2-01 vehicle, irradiation

Application with MC2-01 vehicle, followed by irradiation

Group Type EXPERIMENTAL

Challenge: Applications of MC2-01 vehicle, irradiation

Intervention Type DRUG

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

Challenge: MC2-01 vehicle, no irradiation

Application with MC2-01 vehicle, no irradiation

Group Type EXPERIMENTAL

Challenge: Applications of MC2-01 vehicle, no irradiation

Intervention Type DRUG

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

Challenge: Control, irradiation

No application, but irradiation

Group Type EXPERIMENTAL

Challenge: Control, irradiation

Intervention Type DRUG

No application, but irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes