- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03012009
Laser Assisted Drug Delivery in the Treatment of Superficial Non Melanoma Skin Cancer: a Randomized Controlled Trial
January 24, 2018 updated by: University Hospital, Ghent
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
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Ghent, Belgium
- Department of Dermatology, Ghent University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
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ablation to the level of de dermal papilla
Other Names:
Other Names:
peak wavelength 630 nm, 37J/cm2
Other Names:
Other Names:
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Active Comparator: 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.
|
Other Names:
peak wavelength 630 nm, 37J/cm2
Other Names:
Other Names:
180 micron HP, pulse 8ms, 15% overlay, 30 W (943J/cm)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical efficacy after twelve months of follow up
Time Frame: month 12
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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.
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month 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical efficacy after six months of follow up
Time Frame: month 6
|
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
|
Clinical efficacy after three months of follow up
Time Frame: month 3
|
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
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Histological efficacy after twelve months of follow up
Time Frame: month 12
|
month 12
|
|
Pain during the first treatment session
Time Frame: immediately after the first treatment session (day 1)
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The experienced pain during the treatment is scored bye the patient using a VAS scale of 100 mm.
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immediately after the first treatment session (day 1)
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Pain during the second treatment session
Time Frame: immediately after the second treatment session (day 14)
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The experienced pain during the treatment is scored by the patient using a VAS scale of 100 mm.
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immediately after the second treatment session (day 14)
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Side effects after the first treatment session
Time Frame: immediately after the first treatment session (day 1)
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The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.
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immediately after the first treatment session (day 1)
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Side effects after one week of follow up, telephone survey
Time Frame: day 7
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The presence of following side effects is evaluated by the patient: erythema, vesicles, pigment changes, scarring, infection and pain.
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day 7
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Side effects before the second treatment session
Time Frame: before initiation of the second treatment session (day 14)
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The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.
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before initiation of the second treatment session (day 14)
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Side effects after the second treatment
Time Frame: immediately after the second treatment session (day 14)
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The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.
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immediately after the second treatment session (day 14)
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Side effects after two weeks of follow up, telephone survey
Time Frame: day 21
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The presence of following side effects is evaluated by the patient: erythema, vesicles, pigment changes, scarring, infection and pain.
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day 21
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Side effects after three months follow up
Time Frame: month 3
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The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.
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month 3
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Side effects after six months of follow up
Time Frame: month 6
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The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.
|
month 6
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Side effects after twelve months of follow up
Time Frame: month 12
|
The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.
|
month 12
|
Aesthetic result after three months of follow up
Time Frame: month 3
|
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
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Aesthetic result after six months of follow up
Time Frame: month 6
|
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
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Aesthetic result after twelve months of follow up
Time Frame: month 12
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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).
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month 12
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Aesthetic result according to the patient after three months of follow up
Time Frame: month 3
|
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).
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month 3
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Aesthetic result according to the patient after six months of follow up
Time Frame: month 6
|
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).
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month 6
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Aesthetic result according to the patient after twelve months of follow up
Time Frame: month 12
|
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).
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month 12
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Technique of preference according to the patient
Time Frame: month 12
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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
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month 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Barbara Boone, MD PhD, Ghent University, Dpt. of Dermatology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2014
Primary Completion (Actual)
May 1, 2017
Study Completion (Actual)
May 1, 2017
Study Registration Dates
First Submitted
November 21, 2016
First Submitted That Met QC Criteria
January 3, 2017
First Posted (Estimate)
January 6, 2017
Study Record Updates
Last Update Posted (Actual)
January 25, 2018
Last Update Submitted That Met QC Criteria
January 24, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Neoplasms, Squamous Cell
- Neoplasms, Basal Cell
- Carcinoma, Squamous Cell
- Skin Neoplasms
- Carcinoma, Basal Cell
- Bowen's Disease
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Photosensitizing Agents
- Dermatologic Agents
- Membrane Transport Modulators
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Anesthetics
- Lidocaine
- Anesthetics, Local
- Epinephrine
- Racepinephrine
- Epinephryl borate
- Methyl 5-aminolevulinate
Other Study ID Numbers
- EC/2014/0735
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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