Photodynamic Treatment of Actinic Keratoses With Different Light Doses

Not Applicable

Completed

• Conditions: Actinic Keratosis
• Interventions: Device: Photodynamic therapy with light dose of 70 J/cm2 using a broad-band red light source; Procedure: Photodynamic therapy with 100J/cm2 light dose using a broad-band red light source

• Registration Number: NCT01541228
• Lead Sponsor: Lithuanian University of Health Sciences

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 Timeline

• Study Start: 2010-04
• Primary Completion: 2011-04
• Study First Submitted: 2012-02-14
• Study First Submitted QC: 2012-02-23
• Study First Posted: 2012-02-29
• Study Completion: 2013-04
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-02
• Last Update Posted: 2013-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. Male or female subject older than 50 years.
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

1. Patients with more than 5 AK in the planned treatment area.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group I	Photodynamic therapy with light dose of 70 J/cm2 using a broad-band red light source	Patients with actinic keratosis (AK) on the left and right sides of face/scalp region treated with photodynamic therapy using 20% 5-aminolevulinic acid.
Group II	Photodynamic therapy with 100J/cm2 light dose using a broad-band red light source	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.

Primary Outcome Measures

Name	Time	Method
Clinically cleared actinic keratosis with histological evaluation when clinically suspicious for relapse	3 months	All treated actinic keratoses evaluated by two investigators for clinical/histological relapse at months 1, 3, 6, 12, 24 after treatment

Secondary Outcome Measures

Name	Time	Method
Pain during the treatment	2 years	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.

Trial Locations

Locations (1)

Department of Skin and Venereal Diseases, Lithuanian University of Health Sciences, Medical Academy; 🇱🇹 Kaunas, Eiveniu st. 2, Lithuania