Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas

Hautklinik Darmstadt100 enrolled

Overview

Pulsed dye laser (PDL) treatments have been suggested to be a safe and effective therapeutic approach for treating basal cell carcinomas. Robust supporting evidence is, however, lacking due to inconsistent design of available studies. The purpose of this study is to evaluate the PDL's efficacy and safety in treating superficial basal cell carcinoma (sBCC) at low risk anatomical sites in an evidence based study setting.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Basal Cell Carcinoma

Interventions

Laser treatmentPROCEDURE

Pulsed dye laser 595nm

SHAM-TreatmentDEVICE

using the pulsed dye laser (PDL) laser without releasing a pulse

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * histologically confirmed unpigmented sBCC on the trunk and extremities * maximal tumour diameter 30 mm Exclusion Criteria: * Fitzpatrick skin type \>III * pregnancy * previous BCC treatment within 4 weeks * coagulation disorders * photo sensitizing medication * any indication of poor compliance

Outcomes

Primary Outcomes

complete response

Time frame: 9 months

Secondary Outcomes

patients satisfaction

questionnaire

Time frame: 9 months

side effects

questionnaire

Time frame: 9 months

reduction of tumor diameter and tumor thickness

Time frame: 9 months

Data from ClinicalTrials.gov

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