NCT02125669

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
Last Updated

April 29, 2014

Status Verified

April 1, 2014

Enrollment Period

10 months

First QC Date

April 13, 2014

Last Update Submit

April 27, 2014

Conditions

Basal Cell Carcinoma

Keywords

basal cell carcinomalaser surgerypulsed dye laserrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • complete response

    9 months

Secondary Outcomes (3)

  • patients satisfaction

    9 months

  • side effects

    9 months

  • reduction of tumor diameter and tumor thickness

    9 months

Study Arms (2)

Laser Treatment

ACTIVE COMPARATOR

Pulsed dye laser 595nm

Procedure: Laser treatment

SHAM Treatment

SHAM COMPARATOR

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

Device: SHAM-Treatment

Interventions

Laser treatmentPROCEDURE

Pulsed dye laser 595nm

Laser Treatment
SHAM-TreatmentDEVICE

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

SHAM Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed unpigmented sBCC on the trunk and extremities
  • maximal tumour diameter 30 mm

You may not qualify if:

  • Fitzpatrick skin type \>III
  • pregnancy
  • previous BCC treatment within 4 weeks
  • coagulation disorders
  • photo sensitizing medication
  • any indication of poor compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Maurizio Podda, Dr.

    Hautklinik Darmstadt

    PRINCIPAL INVESTIGATOR

  • Syrus Karsai, Dr.

    Hautklinik Darmstadt

    STUDY DIRECTOR

  • Heiko Friedl

    Hautklinik Darmstadt

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med.

Study Record Dates

First Submitted

April 13, 2014

First Posted

April 29, 2014

Study Start

November 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

April 29, 2014

Record last verified: 2014-04