- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01541228
Photodynamic Treatment of Actinic Keratoses With Different Light Doses
Clinical Effect of Photodynamic Treatment When Treating Actinic Keratoses With Different Light Doses
Study Overview
Status
Conditions
Detailed Description
To determine and compare clinical and histological effectiveness of different (70 J/cm2 ir 100 J/cm2) light doses when treating actinic keratoses with photodynamic therapy.
To determine pain intensity during photodynamic therapy with visual analogue scale and factors influencing pain during the procedure.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Eiveniu st. 2
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Kaunas, Eiveniu st. 2, Lithuania, LT-50009
- Department of Skin and Venereal Diseases, Lithuanian University of Health Sciences, Medical Academy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female subject older than 50 years.
- Subject has to read Patient Information Sheet and read and sign the Informed Consent form prior to any study related procedure.
- AK with the largest diameter ≤3 cm (measuring the longest axis).
- 2 or more AK with symmetrical distribution on the face or scalp.
- Clinically and histologically confirmed AK of grade I or II.
- Subject must be willing and capable of cooperating to the extent and degree required by the protocol.
- Patient is not the subject of the administrative or legal judicial proceeding.
- Subject has social health security required by laws of health care institutions.
Exclusion Criteria:
- Patients with more than 5 AK in the planned treatment area.
- A recurrent AK: AK that has been previously treated in the study area.
- Very hyperkeratotic, grade 3 (on a 0-3 scale) AK lesions among the target lesions.
- AK located on the nose.
- Other skin lesions (diseases) in the tumor study area.
- Subject with known hereditary basal cell carcinoma syndromes (Gorlin-Goltz, Basex-Dupre-Christol et al.).
- Subject with a history of cutaneous photosensitization or porphyria or Xeroderma pigmentosum, hypersensitivity to porphyrins, or photodermatosis.
- Subject who had received photosensitizing drugs 30 days before study start.
- 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.
- Subject who had participated in another investigational drug or device research study within 30 days of enrolment.
- 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.
- Subject with known hypersensitivity to 5-aminolevulinc acid, a similar compound or excipients of the cream.
- Subject with known status after organ transplantation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: 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.
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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. |
ACTIVE_COMPARATOR: 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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinically cleared actinic keratosis with histological evaluation when clinically suspicious for relapse
Time Frame: 3 months
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All treated actinic keratoses evaluated by two investigators for clinical/histological relapse at months 1, 3, 6, 12, 24 after treatment
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain during the treatment
Time Frame: 2 years
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Patients inform a present investigator about pain severity at the beginning, in the middle, at the end of the session and move a counter of visual analogue scale.
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2 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Evelina Buinauskaite, MD, Lithuanian University of Health Sciences, Medical Academy, Department of Skin and Venereal Diseases
- Study Chair: Skaidra Valiukeviciene, Prof., 1Lithuanian University of Health Sciences, Medical Academy, Department of Skin and Venereal Diseases
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BE-2-60
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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