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Completed

NCT Number: NCT03012009

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

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.

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Key information

Conditions

Bowen's Disease Carcinoma Carcinoma, Squamous Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Superficial Basal Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dermatology, Ghent University Hospital

Ghent, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

full ablative CO2 laser

Device

ablation to the level of de dermal papilla

Other names: full ablative carbon dioxide laser

fractional ablative CO2 laser

Device

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

Other names: fractional ablative carbon dioxide laser

MAL

Drug

Other names: methyl aminolevulinate, Metvix® (Galderma)

LED lamp

Device

peak wavelength 630 nm, 37J/cm2

Other names: Aktilite® (Galderma), light-emitting diodes

lidocaine hydrochloride 2% with epinephrine

Drug

Other names: local anaesthetic, xylocaine® 2% with epinephrine

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 6, 2017
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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