NCT02125669CompletedNot Applicable
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
Hautklinik Darmstadt0 sites100 target enrollmentStarted: November 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Primary Endpoint
- complete response
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
complete response
Time Frame: 9 months
Secondary Outcomes
- patients satisfaction(9 months)
- side effects(9 months)
- reduction of tumor diameter and tumor thickness(9 months)
Investigators
Maurizio Podda
PD Dr. med.
Hautklinik Darmstadt
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