Actinic KeratosisPhase 2/3NCT01260987
Fractional CO2 Laser Assisted Photodynamic Therapy
A Phase 2/3 study testing Conventional photodynamic therapy and Fractional CO2 laser assisted PDT in people with Actinic Keratosis and Basal Cell Carcinoma, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Nodular Basal Cell Carcinomas: Compare the efficacy and safety of conventional versus fractional laser assisted PDT for difficult to treat nodular cell carcinomas in the face. Actinic keratosis: Compare the efficacy and safety of conventional versus fractional laser assisted PDT for moderate to severe actinic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis, Basal Cell Carcinoma
- What is being tested?
- Conventional photodynamic therapy and Fractional CO2 laser assisted PDT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2010to Aug 2012
- Phase
- Phase 2/3
- 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
- Age 18 or older
- Skin type I-III
- Fertile women using secure birth control
- Moderate to severe actinic keratoses in the face or on the hands,
- Difficult to treat nodular basal cell carcinomas in the face
Who cannot join
- Pregnancy or breast feeding patients
- Patients with porphyria
- Patients with Gorlins syndrome
- Patients with a tendency to produce hypertrophic scars or keloids
- Patients with known allergy to Metvix
- Patients who are not considered able to follow the treatment protocol (e.g. severely alcoholic, dementia, mentally ill etc.)
- Patients with pigmented or morphea basal cell carcinomas
- Know herpes simplex virus infection in treatment areas
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Dermatology, Bispebjerg Hospital
Copenhagen, DK-2400
About this study
Official title: Conventional Versus Fractional CO2 Laser Assisted Photodynamic Therapy for Basal Call Carcinomas and Actinic Keratoses
Nodular Basal Cell Carcinomas:
Compare the efficacy and safety of conventional versus fractional laser assisted PDT for difficult to treat nodular cell carcinomas in the face.
Actinic keratosis:
Compare the efficacy and safety of conventional versus fractional laser assisted PDT for moderate to severe actinic keratoses located in the face and on the hands.
- Conditions
- Actinic Keratosis, Basal Cell Carcinoma
- Being tested
- Conventional photodynamic therapy, Fractional CO2 laser assisted PDT
- Keywords
- Moderate to severe actinic keratoses, Difficult to treat nodular basal cell carcinomas
- Medical subject headings
- Keratosis, Actinic, Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional photodynamic therapyDrug
Photodynamic therapy using methyl-aminolevulinate and red light (37 J/cm2)
Fractional CO2 laser assisted PDTDrug
Pretreatment with fractional CO2 laser before methyl-aminolevulinate PDT
| Study group | Role | What they receive |
|---|---|---|
| AK split-face treatment | Active comparator | Split-face treatment of two symmetrical areas with moderate to severe actinic keratoses. One area is treated with conventional PDT the other with fractional laser assisted PDT. Receives: Drug: Conventional photodynamic therapy; Drug: Fractional CO2 laser assisted PDT |
| Fractional laser assisted PDT for BCC | Active comparator | Difficult to treat nodular basal cell carcinomas in the face is pretreated with fractional CO2 laser followed by methyl-aminolevulinate PDT. Receives: Drug: Fractional CO2 laser assisted PDT |
| Konventional PDT for BCC | Active comparator | Difficult to treat nodular basal cell carcinomas in the face is treated with methyl-aminolevulinate PDT. Receives: Drug: Conventional photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response
Clinical evaluation by a blinded physician.
Measured: 3 months
Reoccurrence
Clinical evaluation by a blinded physician
Measured: 12 months
Treatment response
Blinded histological examination from patients with basal cell carcinomas
Measured: 12 months
Secondary outcomes (4)
Pain
Patient score (VAS 0-10)
Measured: during laser and PDT
Adverse effects
scaring, hyper- and hypopigmentation
Measured: 12 months
Fluorescence
Methyl-amonolevulinate uptake
Measured: 3 hours
Cosmetic result
4-point scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Haak, Bispebjerg Hospital
- Investigators
- Merete Hædersdal, PhD,DrMedSci, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260987
- Sponsor's protocol ID
- H-1-2010-044
- Other IDs
- 2010-020179-22
- Status last verified
- Jul 2015
- First submitted
- 14 Dec 2010
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Versus Fractional CO2 Laser Assisted Photodynamic Therapy for Basal Call Carcinomas and Actinic Keratoses
- ClinicalTrials.gov ID
- NCT01260987
- Acronym / sponsor ID
- H-1-2010-044
- Conditions
- Actinic Keratosis, Basal Cell Carcinoma
- Keywords
- Moderate to severe actinic keratoses, Difficult to treat nodular basal cell carcinomas
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 16 Dec 2010 (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.
Nodular Basal Cell Carcinomas:
Compare the efficacy and safety of conventional versus fractional laser assisted PDT for difficult to treat nodular cell carcinomas in the face.
Actinic keratosis:
Compare the efficacy and safety of conventional versus fractional laser assisted PDT for moderate to severe actinic keratoses located in the face and on the hands.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AK split-face treatment | Active comparator | Drug: Conventional photodynamic therapy, Drug: Fractional CO2 laser assisted PDTSplit-face treatment of two symmetrical areas with moderate to severe actinic keratoses. One area is treated with conventional PDT the other with fractional laser assisted PDT. |
| Fractional laser assisted PDT for BCC | Active comparator | Drug: Fractional CO2 laser assisted PDTDifficult to treat nodular basal cell carcinomas in the face is pretreated with fractional CO2 laser followed by methyl-aminolevulinate PDT. |
| Konventional PDT for BCC | Active comparator | Drug: Conventional photodynamic therapyDifficult to treat nodular basal cell carcinomas in the face is treated with methyl-aminolevulinate PDT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or older
- Skin type I-III
- Fertile women using secure birth control
- Moderate to severe actinic keratoses in the face or on the hands,
- Difficult to treat nodular basal cell carcinomas in the face
Key exclusion criteria (8 listed)
- Pregnancy or breast feeding patients
- Patients with porphyria
- Patients with Gorlins syndrome
- Patients with a tendency to produce hypertrophic scars or keloids
- Patients with known allergy to Metvix
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 |
|---|---|---|
| Conventional photodynamic therapyPhotodynamic therapy using methyl-aminolevulinate and red light (37 J/cm2) | Drug | AK split-face treatment, Konventional PDT for BCC |
| Fractional CO2 laser assisted PDTPretreatment with fractional CO2 laser before methyl-aminolevulinate PDT | Drug | AK split-face treatment, Fractional laser assisted PDT for BCC |
Primary outcome
Treatment response
Time frame: 3 months
Clinical evaluation by a blinded physician.
Reoccurrence
Time frame: 12 months
Clinical evaluation by a blinded physician
Treatment response
Time frame: 12 months
Blinded histological examination from patients with basal cell carcinomas
4 secondary outcomes
Pain
Time frame: during laser and PDT
Adverse effects
Time frame: 12 months
Fluorescence
Time frame: 3 hours
Cosmetic result
Time frame: 12 months
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 30 Jul 2015.
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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.
Merete Hædersdal, PhD,DrMedSci principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Conventional photodynamic therapy and Fractional CO2 laser assisted PDT in people with Actinic Keratosis and Basal Cell Carcinoma, run by Bispebjerg Hospital at 1 site in Denmark.
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 5 inclusion and 8 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 30 Jul 2015. 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 Denmark. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Treatment response (time frame: 3 months). The study lists 3 primary outcomes in all. 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 30 Jul 2015.