Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas

NCT ID: NCT02125669

Last Updated: 2014-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Basal Cell Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Laser Treatment

Pulsed dye laser 595nm

Group Type ACTIVE_COMPARATOR

Laser treatment

Intervention Type PROCEDURE

Pulsed dye laser 595nm

SHAM Treatment

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

Group Type SHAM_COMPARATOR

SHAM-Treatment

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laser treatment

Pulsed dye laser 595nm

Intervention Type PROCEDURE

SHAM-Treatment

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Medicine Greifswald

OTHER

Sponsor Role collaborator

Hautklinik Darmstadt

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Maurizio Podda

PD Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maurizio Podda, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hautklinik Darmstadt

Syrus Karsai, Dr.

Role: STUDY_DIRECTOR

Hautklinik Darmstadt

Heiko Friedl

Role: STUDY_CHAIR

Hautklinik Darmstadt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FF57/2012

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.