Dermal Phototoxicity Study

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04070742
• Other study ID #: FX2016-06
• Status: Completed
• Phase: Phase 1
• Start date: August 17, 2016
• Est. completion date: October 1, 2016

Study information

• Verified date: September 2019
• Source: Foamix Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 1, 2016
• Est. primary completion date: September 7, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis, Phototoxic
• Healthy

Intervention

Drug:
• FMX101

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Foamix Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison between Test and Vehicle sites of the post-irradiation erythema severity at 96 hours post-application using a dermal response numerical equivalent score		4 days