NCT03012009

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

A Randomized Controlled Trial of a Full and a Fractional Ablative Carbon Dioxide Laser as Pretreatment for Photodynamic Therapy in the Management of Superficial Non Melanoma Skin Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Superficial Basal Cell Carcinoma (sBCC) and Bowen Disease (BD) are malignant skin tumors localised in the superficial epidermis. These tumors are highly prevalent in the caucasian population. Diagnosis of sBCC and BD is often delayed because the clinical manifestation may be discrete and lesions are sometimes wrongly diagnosed and treated as eczema. Once the diagnosis is established, the lesions may cover an extensive area, making surgical excision more difficult. At that moment, the physician can make use of less invasive techniques such as photodynamic therapy (PDT). Pretreatment with an ablative carbon dioxide (CO2) laser has recently been studied in order to enhance the skin penetration of the photosensitizer methyl aminolevulinate (MAL). 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. Ablation of the upper epiderm of the cancer results in an deeper penetration of MAL. Fractional ablation is known to result in better wound healing compared to full ablative CO2 laser ablation, because only small skin columns are ablated instead of the entire epidermal layer. Patients with non operable sBCC or BD lesions covering an area of at least 5 cm2 or with the presence of two small separated lesions, will be investigated. Lesions greater than 5 cm2 are divided in two. After randomization, the half of the lesions will be pretreated with the full ablative CO2 laser, while the other half with the fractional ablative CO2 laser. Afterwards, the entire surface is treated with MAL-PDT. Such as in our current clinical practice, this treatment modality is repeated after a two week interval. Thus, every subject undergoes both treatment modalities, making within-patient comparison possible. 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

Type	Name	Description
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

Timeline

• Start date: 2014-09-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2017-01-06
• Last updated: 2018-01-25

Locations

1 site across 1 country: Belgium