Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas

Hautklinik Darmstadt

Status: Completed

Conditions: Basal Cell Carcinoma

Treatments: Procedure: Laser treatment; Device: SHAM-Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02125669

FF57/2012

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Laser Treatment

Active Comparator group

Description:

Pulsed dye laser 595nm

Treatment:

Procedure: Laser treatment

SHAM Treatment

Sham Comparator group

Description:

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

Treatment:

Device: SHAM-Treatment