Clinical trial · Interventional
Photodynamic Therapy Using Methyl-5-Aminolevulinate Hydrochloride Cream in Determining Pain Threshold in Patients With Skin Cancer
A Phase I Study for Superficial Basal Cell Carcinoma to Determine the Irradiance - Dependent Pain Threshold for Methylaminolevulinate (MAL)/PDT.
- 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)
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. Photodynamic therapy using methyl-5-aminolevulinate hydrochloride cream may be effective against skin cancer. PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy with methyl-5-aminolevulinate hydrochloride cream in determining pain threshold patients with skin cancer
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma of the Skin | Skin Basal Cell Carcinoma | ALIAS | 0.90 |
| Pain | — | UNRESOLVED | — |
| Recurrent Skin Cancer | Malignant Skin Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laser therapy | Procedure | — | UNRESOLVED |
| methyl-5-aminolevulinate hydrochloride cream | Drug | Methyl Aminolevulinate | ALIAS |
| photodynamic therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I
- description
- Patients apply methyl-5-aminolevulinate hydrochloride (MAL) cream on the lesions and the surrounding normal skin. Beginning 3 hours later, patients undergo laser light treatment for 3-5 minutes.
- interventionNames
- Drug: methyl-5-aminolevulinate hydrochloride cream
- Procedure: laser therapy
- type
- EXPERIMENTAL
- label
- Group II
- description
- Patients apply MAL cream on the lesions and the surrounding normal skin. Beginning 3 hours later, patients undergo light emitting diode treatment for 5-10 minutes.
- interventionNames
- Drug: methyl-5-aminolevulinate hydrochloride cream
- Drug: photodynamic therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with 1-2 superficial basal cell carcinoma (sBCC), 0.5 to 2 cm in diameter * Primary or recurrent lesions may be treated * Diagnosis must be confirmed by biopsy, at least 2 weeks pre treatment * Each patient with \< 8 lesions can contribute a maximum of 2 lesions per treatment session, 1 lesion per light source, which can be treated the same day as permitted by scheduling; the remaining lesions may be treated as soon as scheduling permits with non protocol Photodynamic Therapy * Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Patients not meeting the above selection criteria * Lesions which are not suitable for diagnostic measurements * Patients with \>= 8 lesions to be treated * Carcinomas of types known to have uncertain clinical margins (e.g. morpheaform or infiltrating), or any lesion felt to require Mohs surgery for definitive control * Lesions over boney prominences * Patients with porphyrias or known hypersensitivity to porphyrins * Patients with known photosensitivity diseases * Patients with allergies to Metvixia (MAL) cream ingredients (peanut and almond oil) * Patients previously treated with a systemic photo sensitizer within 4 months * Pregnant or nursing female patients * Patients unwilling or unable to follow protocol requirements * Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug
References
Publications (0)
Data not yet available