NCT03899064

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: MC2 Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Photoallergy

Interventions

Type	Name	Description
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
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
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
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
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
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
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
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
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

Timeline

• Start date: 2019-02-13
• Primary completion: 2019-04-05
• Completion: 2019-04-05
• First posted: 2019-04-02
• Last updated: 2020-03-11
• Results posted: 2020-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study