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NCT02125669 Clinical Trial

Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas

Basal Cell Carcinoma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02125669
Other study ID # FF57/2012
Secondary ID
Status Completed
Phase N/A
First received April 13, 2014
Last updated April 27, 2014
Start date November 2012
Est. completion date September 2013

Study information
Verified date April 2014
Source Hautklinik Darmstadt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Laser treatment
Pulsed dye laser 595nm
Device:
• SHAM-Treatment
using the pulsed dye laser (PDL) laser without releasing a pulse

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Hautklinik Darmstadt University Medicine Greifswald

Outcome
Type Measure Description Time frame Safety issue
Primary complete response 9 months
Secondary patients satisfaction questionnaire 9 months
Secondary side effects questionnaire 9 months
Secondary reduction of tumor diameter and tumor thickness 9 months
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