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

NCT ID: NCT03012009

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Full ablative CO2 laser + MAL PDT

The treatment starts with a full ablative CO2 laser pretreatment under local anaesthesia with injectable lidocaine hydrochloride 2% with epinephrine. This ablation is followed by photodynamic therapy: MAL is topically applied, followed by a 3 hours incubation under occlusion, whereafter 10 minutes of illumination with a LED lamp. This treatment is repeated after 14 days.

Group Type: ACTIVE_COMPARATOR

full ablative CO2 laser

Intervention Type: DEVICE

ablation to the level of de dermal papilla

MAL

Intervention Type: DRUG

LED lamp

Intervention Type: DEVICE

peak wavelength 630 nm, 37J/cm2

lidocaine hydrochloride 2% with epinephrine

Intervention Type: DRUG

Fractional ablative CO2 laser+ MAL PDT

The treatment starts with a fractional ablative CO2 laser ablation under local anaesthesia with injectable lidocaine hydrochloride 2% with epinephrine. This ablation is followed by photodynamic therapy: MAL is topically applied, followed by a 3 hours incubation under occlusion, whereafter 10 minutes of illumination with LED lamp. This treatment is repeated after 14 days.

Group Type: ACTIVE_COMPARATOR

fractional ablative CO2 laser

Intervention Type: DEVICE

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

MAL

Intervention Type: DRUG

LED lamp

Intervention Type: DEVICE

peak wavelength 630 nm, 37J/cm2

lidocaine hydrochloride 2% with epinephrine

Intervention Type: DRUG

Interventions

full ablative CO2 laser

ablation to the level of de dermal papilla

Intervention Type: DEVICE

fractional ablative CO2 laser

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

Intervention Type: DEVICE

MAL

Intervention Type: DRUG

LED lamp

peak wavelength 630 nm, 37J/cm2

Intervention Type: DEVICE

lidocaine hydrochloride 2% with epinephrine

Intervention Type: DRUG

Other Intervention Names

full ablative carbon dioxide laser; fractional ablative carbon dioxide laser; methyl aminolevulinate; Metvix® (Galderma); Aktilite® (Galderma); light-emitting diodes; local anaesthetic; xylocaine® 2% with epinephrine

Eligibility Criteria

Inclusion Criteria

• non operable superficial Basal Cell Carcinoma or Bowen's Disease lesions
• and the presence of at least two lesions or the presence of one lesion covering an area greater than 5cm2

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara Boone, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Ghent University, Dpt. of Dermatology

Locations

Department of Dermatology, Ghent University Hospital

Ghent, , Belgium

Countries

Belgium

Other Identifiers

EC/2014/0735

Identifier Type: -

Identifier Source: org_study_id