CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 58 enrolled
Drug / intervention
Induction: Application of MC2-01 Cream, irradiation +8 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/NCT03899064
NCT03899064Phase 1Completed
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A 6-Week, Randomized Study to Evaluate the Potential of MC2-01 Cream to Induce Photoallergic Skin Reaction in Healthy Subjects, Using a Controlled Photopatch Test Design

MC2 Therapeutics·interventional·Posted Apr 2, 2019·Updated Mar 11, 2020

In Brief

A Phase 1 clinical trial evaluating Induction: Application of MC2-01 Cream, irradiation, Induction: Application of MC2-01 Cream, no irradiation, and 7 other interventions for Photoallergy. Completed, enrolled 58 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedApr 2, 2019
Enrollment StartFeb 13, 2019
Primary CompletionApr 5, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.3 years ago

Interventions

Induction: Application of MC2-01 Cream, irradiationdrug

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

Induction: Application of MC2-01 Cream, no irradiationdrug

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

Induction: Applications of MC2-01 vehicle, irradiationdrug

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

Induction: Applications of MC2-01 vehicle, no irradiationdrug

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

Challenge: Application of MC2-01 Cream, irradiationdrug

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

Challenge: Application of MC2-01 Cream, no irradiationdrug

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

Challenge: Applications of MC2-01 vehicle, irradiationdrug

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

Challenge: Applications of MC2-01 vehicle, no irradiationdrug

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

Challenge: Control, irradiationdrug

No application, but irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema