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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07053852 | Activation of Ameluz With BBL HEROic for the Treatment of Actinic Keratoses and Photodamage | PHASE1 | COMPLETED | 10 | — | — | Jun 27, 2025 | Dec 29, 2025 | Jan 2, 2026 | 1 | United States |
Percentage of actinic keratosis lesion clearance at 1 and 2 months after 2 treatments with the combination of Ameluz and BBL on the face.
Cosmetic outcomes in photoaging of the face evaluated by Subject and Investigator Global Aesthetic Improvement Scale (GAIS) at 1 and 2 months post last PDT. Scale: Very Satisfied (better than expected), Satisfied (as expected), Unsatisfied (worse than expected)
| Arm | Type | Description |
|---|---|---|
| Two PDT treatments | EXPERIMENTAL | Each subject will receive 2 treatments of photodynamic therapy using Ameluz and HEROic BBL to treat facial AK and signs of photodamage. |
| Name | Type | Description |
|---|---|---|
| Ameluz | DRUG | broad band light (BBL) with the use of Ameluz |
| Sciton HEROic | DEVICE | Each subject will receive 2 treatments of photodynamic therapy using Ameluz and HEROic BBL to treat facial AK and signs of photodamage. |
Inclusion Criteria: * Over 18yrs of age * Willingness to participate in all required study activities and visits * Willingness to sign the informed consent form * Visible and palpable signs of diffuse actinic damage and actinic keratoses of mild to moderate severity located on the face * Significan...