NCT03892564

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: MC2 Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Phototoxicity

Interventions

Type	Name	Description
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
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
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
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
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

Timeline

• Start date: 2019-02-27
• Primary completion: 2019-03-09
• Completion: 2019-03-09
• First posted: 2019-03-27
• Last updated: 2020-02-12
• Results posted: 2020-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study