CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 35 enrolled
Drug / intervention
MC2-01 Cream, irradiation +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03892564
NCT03892564Phase 1Completed

A 4-Day, Randomized Study to Evaluate the Potential of MC2-01 Cream to Induce a Phototoxicity Skin Reaction in Healthy Subjects, Using a Controlled Photopatch Test Design

MC2 Therapeutics·interventional·Posted Mar 27, 2019·Updated Feb 12, 2020

In Brief

A Phase 1 clinical trial evaluating MC2-01 Cream, irradiation, MC2-01 Cream, no irradiation, and 3 other interventions for Phototoxicity. Completed, enrolled 35 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPhototoxicity
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedMar 27, 2019
Enrollment StartFeb 27, 2019
Primary CompletionMar 9, 2019
TodayJul 2, 2026
Enrollment to primary: 12 daysPosted 7.3 years ago

Interventions

MC2-01 Cream, irradiationdrug

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

MC2-01 Cream, no irradiationdrug

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

MC2-01 vehicle, irradiationdrug

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

MC2-01 vehicle, no irradiationdrug

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

Control, irradiationdrug

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