Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
47 participants
INTERVENTIONAL
2010-10-31
2012-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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AK split-face treatment
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.
Conventional photodynamic therapy
Photodynamic therapy using methyl-aminolevulinate and red light (37 J/cm2)
Fractional CO2 laser assisted PDT
Pretreatment with fractional CO2 laser before methyl-aminolevulinate PDT
Fractional laser assisted PDT for BCC
Difficult to treat nodular basal cell carcinomas in the face is pretreated with fractional CO2 laser followed by methyl-aminolevulinate PDT.
Fractional CO2 laser assisted PDT
Pretreatment with fractional CO2 laser before methyl-aminolevulinate PDT
Konventional PDT for BCC
Difficult to treat nodular basal cell carcinomas in the face is treated with methyl-aminolevulinate PDT.
Conventional photodynamic therapy
Photodynamic therapy using methyl-aminolevulinate and red light (37 J/cm2)
Interventions
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Conventional photodynamic therapy
Photodynamic therapy using methyl-aminolevulinate and red light (37 J/cm2)
Fractional CO2 laser assisted PDT
Pretreatment with fractional CO2 laser before methyl-aminolevulinate PDT
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bispebjerg Hospital
OTHER
Responsible Party
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Christina Haak
MD
Principal Investigators
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Merete Hædersdal, PhD,DrMedSci
Role: PRINCIPAL_INVESTIGATOR
Bispebjerg Hospital
Locations
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Department of Dermatology, Bispebjerg Hospital
Copenhagen, , Denmark
Countries
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Other Identifiers
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2010-020179-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
H-1-2010-044
Identifier Type: -
Identifier Source: org_study_id
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