NCT01490736

Phase 1/2 Sequentially Staged Safety Study in Healthy Subjects and Subjects With Mild Acne

Phase 1/2 Study of Photodynamic Therapy (PDT) With Lemuteporfin Topical Solution (LTS) in Healthy Volunteers and in Subjects With Mild Acne

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Dermira, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the safety of photodynamic therapy (PDT) with lemuteporfin topical solution (LTS) in healthy subjects and subjects with mild acne.

Detailed description

This is a sequentially staged (Stage 1-4), proof of concept study assessing the safety of photodynamic therapy (PDT) and lemuteporfin topical solution (LTS) in healthy subjects and subjects with mild acne. Approximately 12 subjects will be enrolled in Stage 1 in order to determine a maximum tolerated light dose following LTS application. Up to 90 subjects with mild acne will be enrolled in Stage 2 in order to assess the safety of PDT following a single LTS application. Up to 50 subjects will be enrolled in Stage 3 in order to assess the safety of PDT following repeat LTS applications. Up to 40 subjects will be enrolled into Stage 4 to assess multiple treatments of LTS-PDT.

Conditions

• Acne

Interventions

Type	Name	Description
DRUG	Lemuteporfin	lemuteporfin topical solution, 1%

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-03-01
• Completion: 2013-06-01
• First posted: 2011-12-13
• Last updated: 2021-07-20

Locations

1 site across 1 country: Canada