Clinical Effect of Photodynamic Treatment When Treating Actinic Keratoses With Different Light Doses

Lithuanian University of Health Sciences1 site in 1 country38 target enrollmentApril 2010

ConditionsActinic Keratosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Actinic Keratosis
Sponsor: Lithuanian University of Health Sciences
Enrollment: 38
Locations: 1
Primary Endpoint: Clinically cleared actinic keratosis with histological evaluation when clinically suspicious for relapse
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

April 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Lithuanian University of Health Sciences

Responsible Party

Principal Investigator

Evelina Buinauskaite

Principal investigator

Lithuanian University of Health Sciences

Eligibility Criteria

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.