Clinical trial · Interventional
Topical Laser-assisted Combination Chemotherapy for Basal Cell Carcinoma- a Clinical Study
Tolerability of Laser-assisted Cisplatin + 5-fluorouracil- an Exploratory Proof of Concept Study of Topical Combination Chemotherapy for Basal Cell Carcinoma
- 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)
A prospective clinical, uncontrolled, open-label, explorative phase IIa trial on patients with histologically- confirmed superficial and nodular basal cell carcinoma (BCC) . The study assesses tolerability and tumor clearance after laser-assisted topical delivery of two synergistic chemotherapeutic agents, cisplatin and 5-fluorouracil (5-FU) in BCC patients.
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 |
|---|---|---|---|
| Carcinoma, Basal Cell | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AFL-assisted cisplatin+5-FU | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Basal Cell Carcinoma Patients
- description
- Patients (\>18 years) with histologically-verified superficial or nodular basal cell carcinoma (\<20 mm on the face/scalp, \<50mm on the trunk/extremities)
- interventionNames
- Drug: AFL-assisted cisplatin+5-FU
Primary outcomes (1)
- measure
- Change in Occurence of Local Skin Reaction (LSR) Side Effects TOTAL COMPOSITE SCORE
- timeFrame
- Days 1, 3-5, 14, 30 and 3 months post treatment
- description
- Non-blinded, clinical evaluation of local erythema, edema, flaking, crusting/scabbing, pustulation, scarring, hypo/hyperpigmentation, infection in treated areas will be performed by a physician using a FDA-approved LSR scale at Days 1, 3-5, 14, 30 and 3 months after AFL exposure. Each parameter was graded on a standardized 5-point severity scale (0-4) representing none, mild, moderate, prominent, and severe. A total composite score reflecting overall LSR severity was then calculated based on the sum of all parameters (minimum score 0- least severe; max score: 24-most severe). lower scores are better.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically-verified, previously untreated superficial or nodular BCCs on the scalp, face, extremities or trunk 2. \>18 years of age at baseline 3. Legally competent, able to give verbal and written informed consent 4. Subject in good general health, is willing to participate and can comply with protocol requirements. 5. Fitzpatrick skin phototype I-III 6. Female subjects of childbearing potential1 must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment. Exclusion Criteria: 1. High-risk BCC i. Tumors in the following anatomical locations: midface, orbital, ears ii. Size: \>20 mm in facial/scalp areas or \> 50 mm in non-facial/non-scalp areas iii. Subtype: morpheaform and micronodular BCC iv. History: Gorlin syndrome or immunosuppression 2. Previous treatment of the BCC lesion 3. Known allergy to cisplatin or Efudix® 4. Other skin diseases present in the treatment area 5. Tattoo in the treatment area which may interfere with or confound evaluation of the study 6. History of keloids which is deemed clinically relevant in the opinion of the investigator 7. Fitzpatrick skin phototype IV-VI 8. Lactating or pregnant women
References
Publications (0)
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