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Dermal Phototoxicity Study

Primary Purpose

Healthy

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

FMX101

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy male or female volunteers age 18 years or older
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:

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FMX-101

Arm Description

Outcomes

Primary Outcome Measures

Comparison between Test and Vehicle sites of the post-irradiation erythema severity at 96 hours post-application using a dermal response numerical equivalent score

Secondary Outcome Measures

Full Information

NCT ID

NCT04070742

First Posted

August 8, 2019

Last Updated

September 9, 2019

Sponsor

Vyne Therapeutics Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04070742

Brief Title

Dermal Phototoxicity Study

Official Title

A 4-Day, Randomized, Controlled Study to Evaluate the Phototoxicity Potential of FMX-101, 4% in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

August 17, 2016 (Actual)

Primary Completion Date

September 7, 2016 (Actual)

Study Completion Date

October 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vyne Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FMX-101

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

FMX101

Primary Outcome Measure Information:

Title

Comparison between Test and Vehicle sites of the post-irradiation erythema severity at 96 hours post-application using a dermal response numerical equivalent score

Time Frame

4 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy male or female volunteers age 18 years or older 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: 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 Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study

12. IPD Sharing Statement

Learn more about this trial

Dermal Phototoxicity Study

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