NCT01830764

Open-label Safety and Tolerability Study of LTS-PDT in Healthy Volunteers

An Open-label Safety and Tolerability Study of LTS 0.3% With Red Light Applied to the Backs of Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Dermira, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is assess the safety and tolerability of lemuteporfin topical solution (LTS) with exposure to red light (PDT), when applied to the backs of healthy volunteers.

Detailed description

This is an open-label, safety study in healthy volunteers. Two cohorts, of 6 subjects each, will be enrolled (total subjects = 12). Each subject will have test areas identified on the back and receive a single LTS, vehicle solution and red light (PDT) applied to the test areas on the back. Subjects will be followed for safety at study visits occurring on Day 1 (baseline and treatment), Day 2, and Day 7.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Red Light (PDT)	LTS, 0.3% applied topically followed by red light dose (75 J/cm2 or 150 J/cm2)

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2013-04-12
• Last updated: 2021-07-20

Locations

1 site across 1 country: United States