Dermal Phototoxicity Study

NCT ID: NCT04070742

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-17
• Study Completion Date: 2016-10-01

Brief Summary

Dermal Safety study to determine the Phototoxicity Potential of FMX-101 4% in Healthy Volunteers

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FMX-101

Group Type: EXPERIMENTAL

FMX101

Intervention Type: DRUG

Interventions

FMX101

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy male or female volunteers age 18 years or older

2. Has 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 Criteria

1. Has any visible disease at the application site which, in the opinion of the investigative personnel, would have interfered with the evaluation of the test site reaction

2. Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vyne Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

FX2016-06

Identifier Type: -

Identifier Source: org_study_id