Phase 2 N=20 Treatment

Topical Laser-assisted Combination Chemotherapy for Basal Cell Carcinoma- a Clinical Study

Carcinoma, Basal Cell

Bottom Line

View on ClinicalTrials.gov: NCT03541252 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2022

Primary outcome: Primary: Change in Occurence of Local Skin Reaction (LSR) Side Effects TOTAL COMPOSITE SCORE — 7; 9; 4; 2 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AFL-assisted cisplatin+5-FU (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merete Haedersdal
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Occurence of Local Skin Reaction (LSR) Side Effects TOTAL COMPOSITE SCORE	7; 9; 4; 2	—
SECONDARY Tumor Response- Clinical Clearance Determined by Clinical Assessment by Physician	13; 18	—
SECONDARY Imaging-based Tumor Response: Complete Tumor Clearance Determined by Physician Performing Imaging	13; 18	—
SECONDARY Tumor Response- Histological Tumor Clearance Determined by Pathologist	17	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Histologically-verified, previously untreated superficial or nodular BCCs on the scalp, face, extremities or trunk
>18 years of age at baseline
Legally competent, able to give verbal and written informed consent
Subject in good general health, is willing to participate and can comply with protocol requirements.
Fitzpatrick skin phototype I-III
Female subjects of childbearing potential1 must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment.

Exclusion Criteria

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
Previous treatment of the BCC lesion
Known allergy to cisplatin or Efudix®
Other skin diseases present in the treatment area
Tattoo in the treatment area which may interfere with or confound evaluation of the study
History of keloids which is deemed clinically relevant in the opinion of the investigator
Fitzpatrick skin phototype IV-VI
Lactating or pregnant women

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03541252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.