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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Red light dose (PDT) 75 J/cm2 | Other | Subjects in Cohort 1 will receive active and vehicle solution followed by a red light dose of 75 J/cm2 at 25 mW/cm2 |
|
| Red Light (PDT) 150 J/cm2 | Other | Subjects in Cohort 2 will receive active and vehicle solution followed by a red light dose of 150 J/cm2 at 40 mW/cm2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Red Light (PDT) | Drug | LTS, 0.3% applied topically followed by red light dose (75 J/cm2 or 150 J/cm2) |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan S Dosik, MD | TKL Research Inc (Research Clinics Division) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TKL Research Inc (Research Clinics Division) | Paramus | New Jersey | 07652 | United States |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D010778 | Photochemotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
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