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

NCT03012009 | Completed

• 1 other identifier: EC/2014/0735
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Clinical efficacy after six months of follow up

  month 6

• Clinical efficacy after three months of follow up

  month 3

• Histological efficacy after twelve months of follow up

  month 12

• Pain during the first treatment session

  immediately after the first treatment session (day 1)

• Pain during the second treatment session

  immediately after the second treatment session (day 14)

Study Arms (2)

Full ablative CO2 laser + MAL PDT

ACTIVE COMPARATOR

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.

Device: full ablative CO2 laser; Drug: MAL; Device: LED lamp; Drug: lidocaine hydrochloride 2% with epinephrine

Fractional ablative CO2 laser+ MAL PDT

ACTIVE COMPARATOR

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.

Device: fractional ablative CO2 laser; Drug: MAL; Device: LED lamp; Drug: lidocaine hydrochloride 2% with epinephrine

Interventions

full ablative CO2 laser DEVICE

ablation to the level of de dermal papilla

Also known as: full ablative carbon dioxide laser

Full ablative CO2 laser + MAL PDT

fractional ablative CO2 laser DEVICE

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

Also known as: fractional ablative carbon dioxide laser

Fractional ablative CO2 laser+ MAL PDT

MAL DRUG

Also known as: methyl aminolevulinate, Metvix® (Galderma)

Fractional ablative CO2 laser+ MAL PDT; Full ablative CO2 laser + MAL PDT

LED lamp DEVICE

peak wavelength 630 nm, 37J/cm2

Also known as: Aktilite® (Galderma), light-emitting diodes

Fractional ablative CO2 laser+ MAL PDT; Full ablative CO2 laser + MAL PDT

lidocaine hydrochloride 2% with epinephrine DRUG

Also known as: local anaesthetic, xylocaine® 2% with epinephrine

Fractional ablative CO2 laser+ MAL PDT; Full ablative CO2 laser + MAL PDT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Department of Dermatology, Ghent University Hospital

Ghent, Belgium

Location

MeSH Terms

Conditions

Bowen's Disease

Interventions

methyl 5-aminolevulinate; Lidocaine; Epinephrine; Anesthesia, Local

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Barbara Boone, MD PhD

  Ghent University, Dpt. of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: January 6, 2017
• Study Start: September 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: January 25, 2018

Record last verified: 2018-01

Locations

BE (1)