Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01830764 | Open-label Safety and Tolerability Study of LTS-PDT in Healthy Volunteers | PHASE1 | COMPLETED | 12 | — | — | Apr 1, 2013 | Jun 1, 2013 | Jul 20, 2021 | 1 | United States |
Adverse events and local tolerability assessed at pre and immediately post treatment, at Day 1 and Day 7 following treatment.
| Arm | Type | Description |
|---|---|---|
| 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 |
| Name | Type | Description |
|---|---|---|
| Red Light (PDT) | DRUG | LTS, 0.3% applied topically followed by red light dose (75 J/cm2 or 150 J/cm2) |
Inclusion Criteria: 1. Healthy adults 18 years of age or older 2. Fitzpatrick skin types I-IV Exclusion Criteria: 1. Current pregnancy or lactation. 2. Presence of severe facial acne, acne fulminans or conglobata, or nodulocystic acne. 3. Poor skin condition on the back, including erythema, dryne...