Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas

April 27, 2014 updated by: Maurizio Podda, Hautklinik Darmstadt

The Role of the 595 nm Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas at Low Risk Anatomical Sites: Outcome of a Double Blind Randomized Placebo Controlled Trial

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laser Treatment
Pulsed dye laser 595nm
Procedure: Laser treatment
Pulsed dye laser 595nm
Sham Comparator: SHAM Treatment
using the pulsed dye laser (PDL) laser without releasing a pulse
Device: SHAM-Treatment
using the pulsed dye laser (PDL) laser without releasing a pulse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
complete response
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patients satisfaction
Time Frame: 9 months
questionnaire
9 months
side effects
Time Frame: 9 months
questionnaire
9 months
reduction of tumor diameter and tumor thickness
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hautklinik Darmstadt

Collaborators

University Medicine Greifswald

Investigators

  • Principal Investigator: Maurizio Podda, Dr., Hautklinik Darmstadt
  • Study Director: Syrus Karsai, Dr., Hautklinik Darmstadt
  • Study Chair: Heiko Friedl, Hautklinik Darmstadt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

April 13, 2014

First Submitted That Met QC Criteria

April 27, 2014

First Posted (Estimate)

April 29, 2014

Study Record Updates

Last Update Posted (Estimate)

April 29, 2014

Last Update Submitted That Met QC Criteria

April 27, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF57/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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