NCT03899064 - Evaluation of Potential Development of Photoallergic Skin Reaction After Use of MC2-01 Cream | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 13, 2019

Primary Completion Date

April 5, 2019

Study Completion Date

April 5, 2019

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

Trial Locations (1)

07410

TKL Research Inc., Fair Lawn