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

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ClinicalTrials.gov Identifier: NCT03012009
Recruitment Status : Completed
First Posted : January 6, 2017
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

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.

Condition or disease Intervention/treatment Phase
Bowen's Disease Superficial Basal Cell Carcinoma Device: full ablative CO2 laser Device: fractional ablative CO2 laser Drug: MAL Device: LED lamp Drug: lidocaine hydrochloride 2% with epinephrine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

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.
Device: full ablative CO2 laser
ablation to the level of de dermal papilla
Other Name: full ablative carbon dioxide laser

Drug: MAL
Other Names:
  • methyl aminolevulinate
  • Metvix® (Galderma)

Device: LED lamp
peak wavelength 630 nm, 37J/cm2
Other Names:
  • Aktilite® (Galderma)
  • light-emitting diodes

Drug: lidocaine hydrochloride 2% with epinephrine
Other Names:
  • local anaesthetic
  • xylocaine® 2% with epinephrine

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.
Device: fractional ablative CO2 laser
180 micron HP, pulse 8ms, 15% overlay, 30 W (943J/cm)
Other Name: fractional ablative carbon dioxide laser

Drug: MAL
Other Names:
  • methyl aminolevulinate
  • Metvix® (Galderma)

Device: LED lamp
peak wavelength 630 nm, 37J/cm2
Other Names:
  • Aktilite® (Galderma)
  • light-emitting diodes

Drug: lidocaine hydrochloride 2% with epinephrine
Other Names:
  • local anaesthetic
  • xylocaine® 2% with epinephrine




Primary Outcome Measures :
  1. Clinical efficacy after twelve months of follow up [ Time Frame: month 12 ]
    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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Histological efficacy after twelve months of follow up [ Time Frame: month 12 ]
  4. Pain during the first treatment session [ Time Frame: immediately after the first treatment session (day 1) ]
    The experienced pain during the treatment is scored bye the patient using a VAS scale of 100 mm.

  5. Pain during the second treatment session [ Time Frame: immediately after the second treatment session (day 14) ]
    The experienced pain during the treatment is scored by the patient using a VAS scale of 100 mm.

  6. Side effects after the first treatment session [ Time Frame: immediately after the first treatment session (day 1) ]
    The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.

  7. Side effects after one week of follow up, telephone survey [ Time Frame: day 7 ]
    The presence of following side effects is evaluated by the patient: erythema, vesicles, pigment changes, scarring, infection and pain.

  8. Side effects before the second treatment session [ Time Frame: before initiation of the second treatment session (day 14) ]
    The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.

  9. Side effects after the second treatment [ Time Frame: immediately after the second treatment session (day 14) ]
    The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.

  10. Side effects after two weeks of follow up, telephone survey [ Time Frame: day 21 ]
    The presence of following side effects is evaluated by the patient: erythema, vesicles, pigment changes, scarring, infection and pain.

  11. Side effects after three months follow up [ Time Frame: month 3 ]
    The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.

  12. Side effects after six months of follow up [ Time Frame: month 6 ]
    The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.

  13. 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.

  14. 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).

  15. 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).

  16. Aesthetic result after twelve months of follow up [ Time Frame: month 12 ]
    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).

  17. 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).

  18. 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).

  19. 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).

  20. Technique of preference according to the patient [ Time Frame: month 12 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03012009


Locations
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Belgium
Department of Dermatology, Ghent University Hospital
Ghent, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Barbara Boone, MD PhD Ghent University, Dpt. of Dermatology

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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT03012009     History of Changes
Other Study ID Numbers: EC/2014/0735
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Hospital, Ghent:
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
Additional relevant MeSH terms:
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Anesthetics, Local
Anesthetics
Carcinoma, Basal Cell
Skin Neoplasms
Bowen's Disease
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Lidocaine
Epinephrine
Racepinephrine
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents