Clinical trial NCT03012009: Laser Assisted Drug Delivery in the Treatment of Superficial Non Melanoma Skin Cancer: a Randomized Controlled Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowen's Disease
Superficial Basal Cell Carcinoma
Keywords: Bowen's Disease
Superficial Basal Cel Carcinoma
Non melanoma skin cancer
Photodynamic therapy
PDT
CO2 laser
Laser assisted drug delivery
Carbon dioxide laser
Laser assisted photodynamic therapy
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria: patients with the presence of

* 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

Exclusion Criteria: pregnancy and/or breast feeding

Primary outcomes:
measure: Clinical efficacy after twelve months of follow up
timeFrame: month 12
Secondary outcomes:
measure: Clinical efficacy after six months of follow up
timeFrame: month 6
measure: Clinical efficacy after three months of follow up
timeFrame: month 3
measure: Histological efficacy after twelve months of follow up
timeFrame: month 12
measure: Pain during the first treatment session
timeFrame: immediately after the first treatment session (day 1)
measure: Pain during the second treatment session
timeFrame: immediately after the second treatment session (day 14)
measure: Side effects after the first treatment session
timeFrame: immediately after the first treatment session (day 1)
measure: Side effects after one week of follow up, telephone survey
timeFrame: day 7
measure: Side effects before the second treatment session
timeFrame: before initiation of the second treatment session (day 14)
measure: Side effects after the second treatment
timeFrame: immediately after the second treatment session (day 14)
measure: Side effects after two weeks of follow up, telephone survey
timeFrame: day 21
measure: Side effects after three months follow up
timeFrame: month 3
measure: Side effects after six months of follow up
timeFrame: month 6
measure: Side effects after twelve months of follow up
timeFrame: month 12
measure: Aesthetic result after three months of follow up
timeFrame: month 3
measure: Aesthetic result after six months of follow up
timeFrame: month 6
measure: Aesthetic result after twelve months of follow up
timeFrame: month 12
measure: Aesthetic result according to the patient after three months of follow up
timeFrame: month 3
measure: Aesthetic result according to the patient after six months of follow up
timeFrame: month 6
measure: Aesthetic result according to the patient after twelve months of follow up
timeFrame: month 12
measure: Technique of preference according to the patient
timeFrame: month 12
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Department of Dermatology, Ghent University Hospital
Study officials:
affiliation: Ghent University, Dpt. of Dermatology
name: Barbara Boone, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: