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

Acne Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01490736
Study type Interventional
Source Eli Lilly and Company
Contact
Status Completed
Phase Phase 1/Phase 2
Start date December 2011
Completion date June 2013
View Details
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