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

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.

Conditions

• Photoallergy

Interventions

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

Sponsors & Collaborators

• MC2 Therapeutics

  lead INDUSTRY

Principal Investigators

• Jonathan S Dosik, MD · TKL Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-02-13

Primary Completion

2019-04-05

Completion

2019-04-05

FDA Drug

Yes

Countries

• United States

Study Locations