MedTrace Logo

Laser Assisted Drug Delivery in the Treatment of Superficial Non Melanoma Skin Cancer: a Randomized Controlled Trial

NCT03012009 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-01-25

No results posted yet for this study

Summary

Photodynamic therapy (PDT) is a well established treatment option for superficial non melanoma skin cancer, such as superficial basal cell carcinoma (sBCC) and Bowen Disease (BD). However, a limited uptake of the topically applied photosensitizer methyl aminolevulinate (MAL) may reduce its efficacy. Pretreatment with an ablative carbon dioxide (CO2) laser has recently been studied in order to enhance the skin penetration of this photosensitizer. This study compares the results of a full ablative and a fractional ablative CO2 laser mode as pretreatment of PDT in the management of sBCC and BD. The endpoints efficacy, pain, aesthetics and patient preference are investigated during twelve months of follow up.

Conditions

  • Bowen's Disease
  • Superficial Basal Cell Carcinoma

Interventions

DEVICE

full ablative CO2 laser

ablation to the level of de dermal papilla

DEVICE

fractional ablative CO2 laser

180 micron HP, pulse 8ms, 15% overlay, 30 W (943J/cm)

DRUG

MAL

DEVICE

LED lamp

peak wavelength 630 nm, 37J/cm2

DRUG

lidocaine hydrochloride 2% with epinephrine

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Barbara Boone, MD PhD · Ghent University, Dpt. of Dermatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03012009 on ClinicalTrials.gov