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

Superficial Basal Cell Carcinoma Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03012009
• Other study ID #: EC/2014/0735
• Status: Completed
• Phase: N/A
• First received: November 21, 2016
• Last updated: January 24, 2018
• Start date: September 2014
• Est. completion date: May 2017

Study information

• Verified date: January 2018
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bowen's Disease
• Carcinoma, Basal Cell
• Skin Neoplasms
• Superficial Basal Cell Carcinoma

Intervention

Device:
• full ablative CO2 laser
ablation to the level of de dermal papilla
• 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

Locations

Country	Name	City	State
Belgium	Department of Dermatology, Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical efficacy after twelve months of follow up	A three point scale with complete regression (CR), partial regression (PR) and no regression (NR) defined respectively as 100%, 25-99% and 0-25% regression.	month 12
Secondary	Clinical efficacy after six months of follow up	A three point scale with complete regression (CR), partial regression (PR) and no regression (NR) defined respectively as 100%, 25-99% and 0-25% regression.	month 6
Secondary	Clinical efficacy after three months of follow up	A three point scale with complete regression (CR), partial regression (PR) and no regression (NR) defined respectively as 100%, 25-99% and 0-25% regression.	month 3
Secondary	Histological efficacy after twelve months of follow up		month 12
Secondary	Pain during the first treatment session	The experienced pain during the treatment is scored bye the patient using a VAS scale of 100 mm.	immediately after the first treatment session (day 1)
Secondary	Pain during the second treatment session	The experienced pain during the treatment is scored by the patient using a VAS scale of 100 mm.	immediately after the second treatment session (day 14)
Secondary	Side effects after the first treatment session	The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.	immediately after the first treatment session (day 1)
Secondary	Side effects after one week of follow up, telephone survey	The presence of following side effects is evaluated by the patient: erythema, vesicles, pigment changes, scarring, infection and pain.	day 7
Secondary	Side effects before the second treatment session	The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.	before initiation of the second treatment session (day 14)
Secondary	Side effects after the second treatment	The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.	immediately after the second treatment session (day 14)
Secondary	Side effects after two weeks of follow up, telephone survey	The presence of following side effects is evaluated by the patient: erythema, vesicles, pigment changes, scarring, infection and pain.	day 21
Secondary	Side effects after three months follow up	The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.	month 3
Secondary	Side effects after six months of follow up	The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.	month 6
Secondary	Side effects after twelve months of follow up	The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.	month 12
Secondary	Aesthetic result after three months of follow up	The aesthetic result is scored by a blinded investigator using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).	month 3
Secondary	Aesthetic result after six months of follow up	The aesthetic result is scored a by blinded investigator using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).	month 6
Secondary	Aesthetic result after twelve months of follow up	The aesthetic result is scored a by blinded investigator using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).	month 12
Secondary	Aesthetic result according to the patient after three months of follow up	The aesthetic result is scored by the patient using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).	month 3
Secondary	Aesthetic result according to the patient after six months of follow up	The aesthetic result is scored by the patient using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).	month 6
Secondary	Aesthetic result according to the patient after twelve months of follow up	The aesthetic result is scored by the patient using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).	month 12
Secondary	Technique of preference according to the patient	Patients are asked for their preferred therapy. Following options exist: (1) full ablative CO2 laser + PDT, (2) fractional ablative CO2 laser + PDT, (3) no preference	month 12