Photodynamic Treatment of Actinic Keratoses With Different Light Doses

Actinic Keratosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541228
• Other study ID #: BE-2-60
• Status: Completed
• Phase: N/A
• First received: February 14, 2012
• Last updated: September 2, 2013
• Start date: April 2010
• Est. completion date: April 2013

Study information

• Verified date: September 2013
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lithuania: Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 2013
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Device:
• Photodynamic therapy with light dose of 70 J/cm2 using a broad-band red light source
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.

Procedure:
• Photodynamic therapy with 100J/cm2 light dose using a broad-band red light source
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.

Locations

Country	Name	City	State
Lithuania	Department of Skin and Venereal Diseases, Lithuanian University of Health Sciences, Medical Academy	Kaunas	Eiveniu st. 2

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

References & Publications (1)

Buinauskaite E, Zalinkevicius R, Buinauskiene J, Valiukeviciene S. Pain during topical photodynamic therapy of actinic keratoses with 5-aminolevulinic acid and red light source: randomized controlled trial. Photodermatol Photoimmunol Photomed. 2013 Aug;29 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically cleared actinic keratosis with histological evaluation when clinically suspicious for relapse	All treated actinic keratoses evaluated by two investigators for clinical/histological relapse at months 1, 3, 6, 12, 24 after treatment	3 months	No
Secondary	Pain during the treatment	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.	2 years	No