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Completed

NCT Number: NCT02125669

Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas

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.

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Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laser treatment

Procedure

Pulsed dye laser 595nm

SHAM-Treatment

Device

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

Primary outcomes

  1. complete response

    Time frame: 9 months

Secondary outcomes

  1. patients satisfaction

    Time frame: 9 months

    questionnaire

  2. side effects

    Time frame: 9 months

    questionnaire

  3. reduction of tumor diameter and tumor thickness

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Hautklinik Darmstadt

Other

Collaborators

  • University Medicine Greifswald

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 29, 2014
Registry last updated
Apr 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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