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

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.

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.