NCT01541228CompletedNot Applicable
Clinical Effect of Photodynamic Treatment When Treating Actinic Keratoses With Different Light Doses
Lithuanian University of Health Sciences2 sites in 1 country38 target enrollmentStarted: April 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 38
- Locations
- 2
- Primary Endpoint
- Clinically cleared actinic keratosis with histological evaluation when clinically suspicious for relapse
Study Overview
Brief Summary
Aim of the study: To evaluate clinical effectiveness of two different light doses when treating actinic keratoses with photodynamic therapy with 20% 5-aminolevulinic acid.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Clinically cleared actinic keratosis with histological evaluation when clinically suspicious for relapse
Time Frame: 3 months
All treated actinic keratoses evaluated by two investigators for clinical/histological relapse at months 1, 3, 6, 12, 24 after treatment
Secondary Outcomes
- Pain during the treatment(2 years)
Investigators
Evelina Buinauskaite
Principal investigator
Lithuanian University of Health Sciences
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
Comparison of PDT, Intravitreal Ranibizumab and Combination for Polypoidal Choroidal Vasculopathy Under 1+PRN RegimenPolypoidal Choroidal VasculopathyNCT03459144Sun Yat-sen University60
Completed
Phase 2
effect of photodynamic therapy by Curcumin mouthwash on Streptococcal MutansPatients undergoing fixed orthodontic treatment.IRCT20201125049490N1Sanandaj University of Medical Sciences120
Not yet recruiting
Phase 3
Effect of photodynamic therapy on chronic periodontitisChronic periodontitis.Chronic periodontitisK05.3IRCT20231112060032N1Mashhad University of Medical Sciences35
Enrolling By Invitation
Not Applicable
Clinical and Radiographic Evaluation of Photodynamic Therapy for Root Canal Treatment of Primary MolarsPhotodynamic TherapyNCT05820750Mansoura University60
Active, not recruiting
Not Applicable
Effect of laser therapy in patients with gums problemsChronic periodontitisRBR-62wx9bDepartamento de Odontologia - Universidade Federal do Rio Grande do Norte (UFRN)