Photodynamic Treatment of Actinic Keratoses With Different Light Doses

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.

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.