Basal Cell Carcinoma
Conditions
Keywords
basal cell carcinoma, laser surgery, pulsed dye laser, randomized controlled trial
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.
Interventions
PROCEDURELaser treatment
Pulsed dye laser 595nm
DEVICESHAM-Treatment
using the pulsed dye laser (PDL) laser without releasing a pulse
Sponsors
University Medicine Greifswald
Hautklinik Darmstadt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response | 9 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| patients satisfaction | 9 months | questionnaire |
| side effects | 9 months | questionnaire |
| reduction of tumor diameter and tumor thickness | 9 months | — |
Outcome results
None listed