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MC2-01 Cream, irradiation for Phototoxicity

Phase 1

Waitlist Available

Led By Jonathan S Dorsik

Research Sponsored by MC2 Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48h post-irradiation

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Phototoxicity

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48h post-irradiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48h post-irradiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48h post-irradiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Administration, Cutaneous

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: MC2-01 vehicle, no irradiationExperimental Treatment1 Intervention

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 II: MC2-01 vehicle, irradiationExperimental Treatment1 Intervention

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 III: MC2-01 Cream, no irradiationExperimental Treatment1 Intervention

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 IV: MC2-01 Cream, irradiationExperimental Treatment1 Intervention

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

Group V: Control, irradiationExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Control, irradiation

2019

Completed Phase 1

~40

MC2-01 Cream, irradiation

2019

Completed Phase 1

~40