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Evaluation of Potential Phototoxicity Skin Reaction After Use of MC2-01 Cream

NCT03892564 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2020-02-12

Study results available
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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.

Conditions

  • Phototoxicity

Interventions

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

Sponsors & Collaborators

  • MC2 Therapeutics

    lead INDUSTRY

Principal Investigators

  • Jonathan S Dorsik · TKL Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-27
Primary Completion
2019-03-09
Completion
2019-03-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03892564 on ClinicalTrials.gov