Clinical trial · Interventional
Activation of Ameluz With BBL HEROic for the Treatment of Actinic Keratoses and Photodamage
NCT07053852CI-TRIAL-00100009completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To provide a treatment of both actinic keratoses and photodamage within one treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratoses | — | UNRESOLVED | — |
| Photodamage | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ameluz | Drug | 5-Aminolevulinic Acid | ALIAS |
| Sciton HEROic | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Two PDT treatments
- description
- Each subject will receive 2 treatments of photodynamic therapy using Ameluz and HEROic BBL to treat facial AK and signs of photodamage.
- interventionNames
- Drug: Ameluz
- Device: Sciton HEROic
Primary outcomes (2)
- measure
- Percentage of clearance of actinic keratoses
- timeFrame
- 2 months
- description
- Percentage of actinic keratosis lesion clearance at 1 and 2 months after 2 treatments with the combination of Ameluz and BBL on the face.
- measure
- Cosmetic outcomes
- timeFrame
- 2 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * Significant signs of photoaging, evaluated by investigator, that include any or all the following: * Dyspigmentation * Solar lentigines * Telangiectasias * Diffuse erythema * Roughness and other textural changes * Fine lines * Wrinkles * Actinic bronzing Exclusion Criteria: * Subject who is unable and unwilling to provide consent for study schedule and procedures * Subject who is pregnant or trying to become pregnant during the study * Subjects using any topical treatment on their AKs; must stop at least one month prior * Subjects currently undergoing cancer treatment with medical or radiation therapy * Subjects with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material * Subjects with history of a photosensitivity disease, such as porphyria cutanea tarda
References
Publications (0)
Data not yet available
No reference posted for this study.