Phase 1/2 Sequentially Staged Safety Study in Healthy Subjects and Subjects With Mild Acne
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase 1/2 Study of Photodynamic Therapy (PDT) With Lemuteporfin Topical Solution (LTS) in Healthy Volunteers and in Subjects With Mild Acne|
- Change in sebum excretion rate [ Time Frame: Baseline to Day 14 ] [ Designated as safety issue: No ]
- Change in biomarkers (e.g., caspase-3, CD163, neutrophil elastase) [ Time Frame: Baseline to Day 14 ] [ Designated as safety issue: No ]
- Change in acne lesion count [ Time Frame: Baseline to Day 14 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||June 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Within subject control study
lemuteporfin topical solution, 1%
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.