Clinical trial · Interventional
Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer
Evaluation of Protoporphyrin Formation in Non-Melanoma Skin Cancers After Topical Application of 5-Aminolevulinic Acid: A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Of the 8 histologically proven tumors, detection of PpIX proved to be ambiguous.
Summary
Brief summary (as posted)
RATIONALE: Studying samples of tumor tissue in the laboratory from patients with nonmelanoma skin cancer that has been treated with topical aminolevulinic acid may help doctors predict how patients will respond to photodynamic therapy. PURPOSE: This clinical trial is studying topical aminolevulinic acid in patients with nonmelanoma skin cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-melanomatous Skin Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aminolevulinic Acid | Drug | Aminolevulinic Acid | ALIAS |
| biopsy | Procedure | — | UNRESOLVED |
| diagnostic imaging technique | Procedure | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Maximum depth of protoporphyrin IX (PpIX) fluorescence within different types of nonmelanoma skin cancers after topical aminolevulinic acid (ALA) administration
- timeFrame
- Day 1
Secondary outcomes (3)
- measure
- In vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods
- timeFrame
- Day 1
- measure
- Correlation of the level of PpIX fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors
- timeFrame
- Day 1
- measure
- Establishment of a skin cancer tissue bank
- timeFrame
- Day 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Must have at least 1 biopsy-proven nonmelanoma skin cancer with a minimum diameter of 4 mm * No tumors located on the eyelids, distal nose, cartilaginous portions of the ears, or lips PATIENT CHARACTERISTICS: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known hypersensitivity to aminolevulinic acid or any component of this medication PRIOR CONCURRENT THERAPY: * Concurrent immunosuppressive or chemotherapeutic medications allowed * Concurrent corticosteroids (taken by mouth or large doses taken with an inhaler) allowed * Concurrent systemic retinoids (e.g., isotretinoin, acitretin, bexarotene, alitretinoin) or vitamin A allowed * Other concurrent medications that may affect epidermal growth and differentiation (e.g., anti-EGFR monoclonal antibodies) allowed * No concurrent participation in another clinical trial * No concurrent topical treatment for the target tumor or for other nonmelanoma skin cancers * No concurrent medical therapy or radiotherapy for other cancers
References
Publications (0)
Data not yet available