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CompletedNCT01541228Updated Sep 4, 2013

Photodynamic Treatment of Actinic Keratoses With Different Light Doses

An interventional study of Photodynamic therapy with light dose of 70 J/cm2 using a broad-band red light source and Photodynamic therapy with 100J/cm2 light dose using a broad-band red light source in Actinic Keratosis, sponsored by Lithuanian University of Health Sciences. Completed at 1 site in Lithuania. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2013-09-04.

Sponsored by Lithuanian University of Health Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Actinic Keratosis

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Keywords

  • actinic keratosis
  • photodynamic therapy
  • 5-aminolevulinic acid
03

In context

Keratosis, Actinic

369 studies on the registry are indexed under Keratosis, Actinic; 30 are open to participants now.

This study's enrollment of 38 is below the median of 60 across 318 interventional studies indexed under Keratosis, Actinic.

Browse Keratosis, Actinic studies →

Lead sponsor

Lithuanian University of Health Sciences is the lead sponsor of 104 studies on the registry; 31 are open to participants now.

Browse Lithuanian University of Health Sciences studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
38 participants (actual)

Study arms

  • Active comparator
    Group I

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

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

  • Active comparator
    Group II

    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.

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

Interventions

  • DevicePhotodynamic 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.

  • ProcedurePhotodynamic 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months

Secondary outcomes

  1. 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.

    Time frame: 2 years

07

Study locations

1 site
  • Department of Skin and Venereal Diseases, Lithuanian University of Health Sciences, Medical Academy
    Kaunas, Eiveniu Saint 2 LT-50009, Lithuania
08

References and documents

Publications

  • 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. PubMed 23815349 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01541228
Lead sponsor
Lithuanian University of Health Sciences
Responsible party
Evelina Buinauskaite (Principal investigator, Lithuanian University of Health Sciences) — Principal investigator
First posted
Feb 29, 2012
Start date
Apr 2010
Primary completion
Apr 2011
Completion
Apr 2013
Last update
Sep 4, 2013

Study contacts

Evelina Buinauskaite, MD
principal investigator · Lithuanian University of Health Sciences, Medical Academy, Department of Skin and Venereal Diseases
Skaidra Valiukeviciene, Prof.
study chair · 1Lithuanian University of Health Sciences, Medical Academy, Department of Skin and Venereal Diseases

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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