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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-27

Study Completion Date

2019-03-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Phototoxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One treatment with MC2-01 Cream, MC2-01 vehicle and control on defined applications site (N=5), followed by irradiation/non-irradiation and evaluation 24 or 48 hours post irradiation, within subject comparison model

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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MC2-01 Cream, irradiation

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

Group Type EXPERIMENTAL

MC2-01 Cream, irradiation

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

MC2-01 Cream, no irradiation

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

MC2-01 vehicle, irradiation

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

MC2-01 vehicle, no irradiation

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Control, irradiation

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

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 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes