Status:

COMPLETED

Dermal Photo Allergic Skin Reaction

Lead Sponsor:

Vyne Therapeutics Inc.

Conditions:

Healthy

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

A 6-Week, Randomized Study to Evaluate the Potential of FMX-101, 4% And Vehicle to Induce a Photo Allergic Skin Reaction in Healthy Volunteers, Using a Controlled Photo Patch Test Design

Eligibility Criteria

Inclusion

  • Healthy male or female who were 18 years of age or older
  • Had uniformly-colored skin on the lower thoracic area of the back which allowed discernment of erythema, and were Fitzpatrick Skin Types I, II or III

Exclusion

  • Had any visible skin disease at the application site which, in the opinion of the investigative personnel, would have interfered with the evaluation of the test site reaction
  • Had damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles or other disfigurations of the test site

Key Trial Info

Start Date :

September 21 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 18 2016

Estimated Enrollment :

56 Patients enrolled

Trial Details

Trial ID

NCT04070755

Start Date

September 21 2016

End Date

December 18 2016

Last Update

August 28 2019

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