Clinical trial · Interventional
Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitizers: HAL and BF-200 ALA Versus MAL
Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitizers: Hexylaminolevulinate and Aminolevulinic Acid Nano Emulsion Versus Methylaminolevulinate
- 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)
This pilot study compares three photosensitisers, hexylaminolevulinate (HAL) and aminolevulinic acid nano emulsion (BF-200 ALA) to methylaminolevulinate (MAL) in photodynamic therapy of superficially growing basal cell carcinomas. Study is conducted using randomised prospective double blinded comparing design. Fluorescence is measured in A.U. (Arbitrary Unit) with standardised set-up before and after the exposure. Efficacy is assessed clinically, histologically and by hyperspectral imaging system at 3 months, 12 months and 5 years.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Basal Cell | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Neoplasms, Basal Cell | Basal Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Photochemotherapy | — | UNRESOLVED | — |
| Photosensitizing Agents | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aminolevulinic Acid Nano Emulsion | Drug | — | UNRESOLVED |
| Hexylaminolevulinate cream | Drug | — | UNRESOLVED |
| Methylaminolevulinate cream | Drug | Methyl Aminolevulinate | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Hexylaminolevulinate cream
- description
- 2% Hexylaminolevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream
- interventionNames
- Drug: Hexylaminolevulinate cream
- type
- EXPERIMENTAL
- label
- Aminolevulinic Acid Nano Emulsion
- description
- 78 mg/g Aminolevulinic Acid Nano Emulsion
- interventionNames
- Drug: Aminolevulinic Acid Nano Emulsion
- type
- ACTIVE_COMPARATOR
- label
- Methylaminolevulinate cream
- description
- 160 mg/g Methylaminolevulinate cream
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * superficial basal cell carcinomas on body area (clinically assessed to be mainly superficially growing and later on a biopsy proven sBCC or thin nBCC) * lesions accepted needs to be 10 cm apart from each other Exclusion Criteria: * pigmented, morpheaform, infiltrative or nodular basal cell carcinomas * lesions that are in face and scalp area * pregnancy * breast feeding * allergy to photosensitizer * phorphyria or photosensitivity
References
Publications (0)
Data not yet available