Bowen's DiseaseNCT03012009
Laser Assisted Drug Delivery in the Treatment of Superficial Non Melanoma Skin Cancer: a Randomized Controlled Trial
A study testing full ablative CO2 laser, fractional ablative CO2 laser and MAL in people with Bowen's Disease and Superficial Basal Cell Carcinoma, run by University Hospital, Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowen's Disease, Superficial Basal Cell Carcinoma
- What is being tested?
- full ablative CO2 laser, fractional ablative CO2 laser and MAL
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2014to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Bowen's Disease, Superficial Basal Cell Carcinoma
- Being tested
- full ablative CO2 laser, fractional ablative CO2 laser, MAL, LED lamp, lidocaine hydrochloride 2% with epinephrine
- 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
- Medical subject headings
- Bowen's Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
full ablative CO2 laserDevice
Also called full ablative carbon dioxide laser
ablation to the level of de dermal papilla
fractional ablative CO2 laserDevice
Also called fractional ablative carbon dioxide laser
180 micron HP, pulse 8ms, 15% overlay, 30 W (943J/cm)
MALDrug
Also called methyl aminolevulinate, Metvix® (Galderma)
LED lampDevice
Also called Aktilite® (Galderma), light-emitting diodes
peak wavelength 630 nm, 37J/cm2
lidocaine hydrochloride 2% with epinephrineDrug
Also called local anaesthetic, xylocaine® 2% with epinephrine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: fractional ablative CO2 laser; Drug: MAL; Device: LED lamp; Drug: lidocaine hydrochloride 2% with epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: month 12
Secondary outcomes (20)
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.
Measured: month 6
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.
Measured: month 3
Histological efficacy after twelve months of follow up
Measured: month 12
Pain during the first treatment session
The experienced pain during the treatment is scored bye the patient using a VAS scale of 100 mm.
Measured: immediately after the first treatment session (day 1)
Pain during the second treatment session
The experienced pain during the treatment is scored by the patient using a VAS scale of 100 mm.
Measured: immediately after the second treatment session (day 14)
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.
Measured: immediately after the first treatment session (day 1)
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.
Measured: day 7
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.
Measured: before initiation of the second treatment session (day 14)
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.
Measured: immediately after the second treatment session (day 14)
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.
Measured: day 21
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.
Measured: month 3
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.
Measured: month 6
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.
Measured: month 12
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).
Measured: month 3
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).
Measured: month 6
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).
Measured: month 12
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).
Measured: month 3
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).
Measured: month 6
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).
Measured: month 12
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
Measured: month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startSep 2014
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowen's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Boone, MD PhD, Principal investigator, Ghent University, Dpt. of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012009
- Sponsor's protocol ID
- EC/2014/0735
- Status last verified
- Jan 2018
- First submitted
- 21 Nov 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03012009
- Acronym / sponsor ID
- EC/2014/0735
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full ablative CO2 laser + MAL PDT | Active comparator | Device: full ablative CO2 laser, Drug: MAL, Device: LED lamp, Drug: lidocaine hydrochloride 2% with epinephrineThe 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. |
| Fractional ablative CO2 laser+ MAL PDT | Active comparator | Device: fractional ablative CO2 laser, Drug: MAL, Device: LED lamp, Drug: lidocaine hydrochloride 2% with epinephrineThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| full ablative CO2 laserAlso: full ablative carbon dioxide laserablation to the level of de dermal papilla | Device | Full ablative CO2 laser + MAL PDT |
| fractional ablative CO2 laserAlso: fractional ablative carbon dioxide laser180 micron HP, pulse 8ms, 15% overlay, 30 W (943J/cm) | Device | Fractional ablative CO2 laser+ MAL PDT |
| MALAlso: methyl aminolevulinate, Metvix® (Galderma) | Drug | Fractional ablative CO2 laser+ MAL PDT, Full ablative CO2 laser + MAL PDT |
| LED lampAlso: Aktilite® (Galderma), light-emitting diodespeak wavelength 630 nm, 37J/cm2 | Device | Fractional ablative CO2 laser+ MAL PDT, Full ablative CO2 laser + MAL PDT |
| lidocaine hydrochloride 2% with epinephrineAlso: local anaesthetic, xylocaine® 2% with epinephrine | Drug | Fractional ablative CO2 laser+ MAL PDT, Full ablative CO2 laser + MAL PDT |
Primary outcome
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.
20 secondary outcomes
Clinical efficacy after six months of follow up
Time frame: month 6
Clinical efficacy after three months of follow up
Time frame: month 3
Histological efficacy after twelve months of follow up
Time frame: month 12
Pain during the first treatment session
Time frame: immediately after the first treatment session (day 1)
Pain during the second treatment session
Time frame: immediately after the second treatment session (day 14)
Side effects after the first treatment session
Time frame: immediately after the first treatment session (day 1)
Side effects after one week of follow up, telephone survey
Time frame: day 7
Side effects before the second treatment session
Time frame: before initiation of the second treatment session (day 14)
Side effects after the second treatment
Time frame: immediately after the second treatment session (day 14)
Side effects after two weeks of follow up, telephone survey
Time frame: day 21
Side effects after three months follow up
Time frame: month 3
Side effects after six months of follow up
Time frame: month 6
Side effects after twelve months of follow up
Time frame: month 12
Aesthetic result after three months of follow up
Time frame: month 3
Aesthetic result after six months of follow up
Time frame: month 6
Aesthetic result after twelve months of follow up
Time frame: month 12
Aesthetic result according to the patient after three months of follow up
Time frame: month 3
Aesthetic result according to the patient after six months of follow up
Time frame: month 6
Aesthetic result according to the patient after twelve months of follow up
Time frame: month 12
Technique of preference according to the patient
Time frame: month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Bowen's Disease
Not yet recruiting
High Intensity Focused Ultrasound vs. Cryotherapy in the Treatment of Basal Cell Carcinomas and Bowen's Disease in Adults
Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Boone, MD PhD principal investigator
Ghent University, Dpt. of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing full ablative CO2 laser, fractional ablative CO2 laser and MAL in people with Bowen's Disease and Superficial Basal Cell Carcinoma, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical efficacy after twelve months of follow up (time frame: month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.