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CompletedNCT02125669Updated Apr 29, 2014

Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas

An interventional study of Laser treatment and SHAM-Treatment in Basal Cell Carcinoma, sponsored by Hautklinik Darmstadt. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-29.

Sponsored by Hautklinik Darmstadt · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Basal Cell Carcinoma

Keywords

  • basal cell carcinoma
  • laser surgery
  • pulsed dye laser
  • randomized controlled trial
03

In context

Carcinoma

6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's enrollment of 100 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Hautklinik Darmstadt is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Fitzpatrick skin type >III
  • pregnancy
  • previous BCC treatment within 4 weeks
  • coagulation disorders
  • photo sensitizing medication
  • any indication of poor compliance
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Laser Treatment

    Pulsed dye laser 595nm

    Procedure: Laser treatment

  • Sham comparator
    SHAM Treatment

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

    Device: SHAM-Treatment

Interventions

  • ProcedureLaser treatment

    Pulsed dye laser 595nm

  • DeviceSHAM-Treatment

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

06

What researchers measure

Primary outcomes

  1. complete response

    Time frame: 9 months

Secondary outcomes

  1. patients satisfaction

    questionnaire

    Time frame: 9 months

  2. side effects

    questionnaire

    Time frame: 9 months

  3. reduction of tumor diameter and tumor thickness

    Time frame: 9 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02125669
Lead sponsor
Hautklinik Darmstadt
Collaborators
University Medicine Greifswald
Responsible party
Maurizio Podda (PD Dr. med., Hautklinik Darmstadt) — Principal investigator
First posted
Apr 29, 2014
Start date
Nov 2012
Primary completion
Sep 2013
Completion
Sep 2013
Last update
Apr 29, 2014

Study contacts

Maurizio Podda, Dr.
principal investigator · Hautklinik Darmstadt
Syrus Karsai, Dr.
study director · Hautklinik Darmstadt
Heiko Friedl
study chair · Hautklinik Darmstadt

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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