Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas

Not Applicable

Completed

• Conditions: Basal Cell Carcinoma
• Interventions: Procedure: Laser treatment; Device: SHAM-Treatment

• Registration Number: NCT02125669
• Lead Sponsor: Hautklinik Darmstadt

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-04
• Study First Submitted: 2014-04-13
• Study First Submitted QC: 2014-04-27
• Last Update Submitted: 2014-04-27
• Study First Posted: 2014-04-29
• Last Update Posted: 2014-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser Treatment	Laser treatment	Pulsed dye laser 595nm
SHAM Treatment	SHAM-Treatment	using the pulsed dye laser (PDL) laser without releasing a pulse

Primary Outcome Measures

Name	Time	Method
complete response	9 months

Secondary Outcome Measures

Name	Time	Method
patients satisfaction	9 months	questionnaire
side effects	9 months	questionnaire
reduction of tumor diameter and tumor thickness	9 months