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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Red Light (PDT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults 18 years of age or older Fitzpatrick skin types I-IV Exclusion Criteria: Current pregnancy or lactation. Presence of severe facial acne, acne fulminans or conglobata, or nodulocystic acne. Poor skin condition on the back, including erythema, dryness, sunburn, dermatological malignancies, infections, cuts, abrasions, tattoo, excess of hair or any other skin condition Subjects who have used any agents known to produce significant photosensitivity reactions (tetracyclines, phenothiazines, trimethoprim, etc.) within 2 weeks of Day 1 or 5 half-lives, whichever is longer. Subjects who have used any medicated topical therapy on the back within 3 days of Day 1. Chronic treatment with low dose aspirin, a non-steroidal anti inflammatory drug (NSAID), or an anticoagulant regimen such as warfarin (Coumadin). Abnormal findings on screening ECG deemed clinically significant by the Investigator. Active participation in an experimental therapy study or experimental therapy within 30 days of Day 1. Screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the Investigator. Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Red light dose (PDT) 75 J/cm2<br>Subjects in Cohort 1 will receive active and vehicle solution followed by a red light dose of 75 J/cm2 at 25 mW/cm2 | Drug: Red Light (PDT)<br>* LTS, 0.3% applied topically followed by red light dose (75 J/cm2 or 150 J/cm2)<br>* Other names: LTS-PDT;|
| Other: Red Light (PDT) 150 J/cm2<br>Subjects in Cohort 2 will receive active and vehicle solution followed by a red light dose of 150 J/cm2 at 40 mW/cm2 | Drug: Red Light (PDT)<br>* LTS, 0.3% applied topically followed by red light dose (75 J/cm2 or 150 J/cm2)<br>* Other names: LTS-PDT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Adverse events and local tolerability assessed at pre and immediately post treatment, at Day 1 and Day 7 following treatment. | 1 week |