Photodynamic Treatment of Actinic Keratoses With Different Light Doses
NCT ID: NCT01541228
Last Updated: 2013-09-04
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
NA
38 participants
INTERVENTIONAL
2010-04-30
2013-04-30
Brief Summary
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Detailed Description
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To determine pain intensity during photodynamic therapy with visual analogue scale and factors influencing pain during the procedure.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Group I
Patients with actinic keratosis (AK) on the left and right sides of face/scalp region treated with photodynamic therapy using 20% 5-aminolevulinic acid.
Photodynamic therapy with light dose of 70 J/cm2 using a broad-band red light source
Patients take part in intraindividual (left-right) comparison study when having at least 2 non-hyperkeratotic actinic keratoses (AK) on the left and right sides of the face/scalp.
Punch biopsies in 3.5 millimetres diameter performed to confirm the diagnosis of AK.
Patients randomized so that half of them would receive a light dose of 70J/cm2 as their first split face/scalp treatment on the left side. Photodynamic therapy with the light dose of 70 J/cm2 using a broad-band red light source (570-670 nm,Curelight®, PhotoCure, Oslo, Norway) and 20% 5-ALA. Treatment repeated twice with two weeks interval.
Group II
Patients with actinic keratosis (AK) on the left and right sides of the face/scalp region treated with photodynamic therapy using 20% 5-aminolevulinic acid.
Photodynamic therapy with 100J/cm2 light dose using a broad-band red light source
Patients take part in intraindividual (left-right) comparison study when having at least 2 non-hyperkeratotic actinic keratoses (AK) on the left and right sides of the face/scalp. Punch biopsies in 3.5 millimetres diameter performed to confirm the diagnosis of AK.
Patients randomized so that half of them would receive a light dose of 100J/cm2 as their first split face/scalp treatment on the left side. Photodynamic therapy with the light dose of 70 J/cm2 using a broad-band red light source (570-670 nm,Curelight®, PhotoCure, Oslo, Norway) and 20% 5-ALA.Treatment repeated twice with two weeks interval.
Interventions
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Photodynamic therapy with light dose of 70 J/cm2 using a broad-band red light source
Patients take part in intraindividual (left-right) comparison study when having at least 2 non-hyperkeratotic actinic keratoses (AK) on the left and right sides of the face/scalp.
Punch biopsies in 3.5 millimetres diameter performed to confirm the diagnosis of AK.
Patients randomized so that half of them would receive a light dose of 70J/cm2 as their first split face/scalp treatment on the left side. Photodynamic therapy with the light dose of 70 J/cm2 using a broad-band red light source (570-670 nm,Curelight®, PhotoCure, Oslo, Norway) and 20% 5-ALA. Treatment repeated twice with two weeks interval.
Photodynamic therapy with 100J/cm2 light dose using a broad-band red light source
Patients take part in intraindividual (left-right) comparison study when having at least 2 non-hyperkeratotic actinic keratoses (AK) on the left and right sides of the face/scalp. Punch biopsies in 3.5 millimetres diameter performed to confirm the diagnosis of AK.
Patients randomized so that half of them would receive a light dose of 100J/cm2 as their first split face/scalp treatment on the left side. Photodynamic therapy with the light dose of 70 J/cm2 using a broad-band red light source (570-670 nm,Curelight®, PhotoCure, Oslo, Norway) and 20% 5-ALA.Treatment repeated twice with two weeks interval.
Eligibility Criteria
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Inclusion Criteria
2. Subject has to read Patient Information Sheet and read and sign the Informed Consent form prior to any study related procedure.
3. AK with the largest diameter ≤3 cm (measuring the longest axis).
4. 2 or more AK with symmetrical distribution on the face or scalp.
5. Clinically and histologically confirmed AK of grade I or II.
6. Subject must be willing and capable of cooperating to the extent and degree required by the protocol.
7. Patient is not the subject of the administrative or legal judicial proceeding.
8. Subject has social health security required by laws of health care institutions.
Exclusion Criteria
2. A recurrent AK: AK that has been previously treated in the study area.
3. Very hyperkeratotic, grade 3 (on a 0-3 scale) AK lesions among the target lesions.
4. AK located on the nose.
5. Other skin lesions (diseases) in the tumor study area.
6. Subject with known hereditary basal cell carcinoma syndromes (Gorlin-Goltz, Basex-Dupre-Christol et al.).
7. Subject with a history of cutaneous photosensitization or porphyria or Xeroderma pigmentosum, hypersensitivity to porphyrins, or photodermatosis.
8. Subject who had received photosensitizing drugs 30 days before study start.
9. Subjects who had received immunomodulatory or immunosuppressive therapies, including systemic and topical steroids, imiquimod or solaraze, interferon and acitretin 6 months prior to study treatment initiation.
10. Subject who had participated in another investigational drug or device research study within 30 days of enrolment.
11. Subject had received in the study area laser resurfacing, chemical peels, topical application fluorouracil or other drugs for the treatment of AKs within 2 months before study entry.
12. Subject with known hypersensitivity to 5-aminolevulinc acid, a similar compound or excipients of the cream.
13. Subject with known status after organ transplantation.
50 Years
ALL
No
Sponsors
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Lithuanian University of Health Sciences
OTHER
Responsible Party
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Evelina Buinauskaite
Principal investigator
Principal Investigators
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Evelina Buinauskaite, MD
Role: PRINCIPAL_INVESTIGATOR
Lithuanian University of Health Sciences, Medical Academy, Department of Skin and Venereal Diseases
Skaidra Valiukeviciene, Prof.
Role: STUDY_CHAIR
1Lithuanian University of Health Sciences, Medical Academy, Department of Skin and Venereal Diseases
Locations
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Department of Skin and Venereal Diseases, Lithuanian University of Health Sciences, Medical Academy
Kaunas, Eiveniu Saint 2, Lithuania
Countries
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References
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Buinauskaite E, Zalinkevicius R, Buinauskiene J, Valiukeviciene S. Pain during topical photodynamic therapy of actinic keratoses with 5-aminolevulinic acid and red light source: randomized controlled trial. Photodermatol Photoimmunol Photomed. 2013 Aug;29(4):173-81. doi: 10.1111/phpp.12044.
Other Identifiers
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BE-2-60
Identifier Type: -
Identifier Source: org_study_id