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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06027619 | Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses | PHASE2 | COMPLETED | 30 | — | — | Oct 2, 2023 | Jul 8, 2024 | Oct 23, 2025 | 1 | United States |
To test the hypothesis that a short-contact PDT protocol with Ameluz and red light will produce lesion clearance outcomes that are statistically non-inferior to the traditional, painful protocol. This will be measured by Clinical Efficacy, which will be based on the AK lesion counts and lesion clearance rate after two treatments.
Pain will be reported by the participants during illumination will be measured on a subjective 11-point visual-analog scale (VAS scale 0= no pain, 10 = intolerable pain)
| Arm | Type | Description |
|---|---|---|
| Regimen A | EXPERIMENTAL | Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source |
| Regimen B | EXPERIMENTAL | Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source |
| Regimen C | EXPERIMENTAL | Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source |
| Name | Type | Description |
|---|---|---|
| Topical aminolevulinate (10% ALA gel) | DRUG | 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period |
| Red light illumination | DEVICE | Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2 |
Inclusion Criteria: * Minimum of 10 actinic keratoses lesions on the face. * Female subjects must not become pregnant during the study * Subjects must be able to understand and willing to sign a written informed consent document. Exclusion Criteria: * Pregnant or nursing. * Using any topical trea...