Back to results

Photodynamic Treatment of Actinic Keratoses With Different Light Doses

Primary Purpose

Actinic Keratosis

Status

Completed

Phase

Not Applicable

Locations

Lithuania

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring actinic keratosis, photodynamic therapy, 5-aminolevulinic acid

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Skin and Venereal Diseases, Lithuanian University of Health Sciences, Medical Academy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group I

Group II

Arm Description

Patients with actinic keratosis (AK) on the left and right sides of face/scalp region treated with photodynamic therapy using 20% 5-aminolevulinic acid.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01541228

First Posted

February 14, 2012

Last Updated

September 2, 2013

Sponsor

Lithuanian University of Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01541228

Brief Title

Photodynamic Treatment of Actinic Keratoses With Different Light Doses

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lithuanian University of Health Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Actinic Keratosis

Keywords

actinic keratosis, photodynamic therapy, 5-aminolevulinic acid

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group I

Arm Type

Active Comparator

Arm Description

Patients with actinic keratosis (AK) on the left and right sides of face/scalp region treated with photodynamic therapy using 20% 5-aminolevulinic acid.

Arm Title

Group II

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Clinically cleared actinic keratosis with histological evaluation when clinically suspicious for relapse

Description

All treated actinic keratoses evaluated by two investigators for clinical/histological relapse at months 1, 3, 6, 12, 24 after treatment

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Pain during the treatment

Description

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.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Evelina Buinauskaite, MD

Organizational Affiliation

Lithuanian University of Health Sciences, Medical Academy, Department of Skin and Venereal Diseases

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Skaidra Valiukeviciene, Prof.

Organizational Affiliation

1Lithuanian University of Health Sciences, Medical Academy, Department of Skin and Venereal Diseases

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Skin and Venereal Diseases, Lithuanian University of Health Sciences, Medical Academy

City

Kaunas

State/Province

Eiveniu st. 2

ZIP/Postal Code

LT-50009

Country

Lithuania

12. IPD Sharing Statement

Citations:

PubMed Identifier

23815349

Citation

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(4):173-81. doi: 10.1111/phpp.12044.

Results Reference

result

Learn more about this trial

Photodynamic Treatment of Actinic Keratoses With Different Light Doses

We'll reach out to this number within 24 hrs