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Photodynamic Treatment of Actinic Keratoses With Different Light Doses

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Evelina Buinauskaite, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier:
NCT01541228
First received: February 14, 2012
Last updated: February 23, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Actinic Keratosis
 Device: Photodynamic therapy with light dose of 70 J/cm2 using a broad-band red light source (570-670 nm, PhotoCureTM Halogen PDT Lamp CureLight BroadBand (CE 0470))
Procedure: Photodynamic therapy with 100J/cm2 light dose using a broad-band red light source (570-670 nm, PhotoCureTM Halogen PDT Lamp CureLight BroadBand (CE 0470))

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical Effect of Photodynamic Treatment When Treating Actinic Keratoses With Different Light Doses

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lithuanian University of Health Sciences:

Primary Outcome Measures:
  • Clinically cleared actinic keratosis with histological evaluation when clinically suspicious for relapse [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 38
Study Start Date: April 2010
Estimated Study Completion Date: April 2013
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 (570-670 nm, PhotoCureTM Halogen PDT Lamp CureLight BroadBand (CE 0470))

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. Treatment repeated twice with two weeks interval.
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 (570-670 nm, PhotoCureTM Halogen PDT Lamp CureLight BroadBand (CE 0470))

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. Treatment repeated twice with two weeks interval.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541228

Locations
Lithuania
Department of Skin and Venereal Diseases, Lithuanian University of Health Sciences, Medical Academy
Kaunas, Eiveniu st. 2, Lithuania, LT-50009
Sponsors and Collaborators
Lithuanian University of Health Sciences
Investigators
Principal Investigator: Evelina Buinauskaite, MD Lithuanian University of Health Sciences, Medical Academy, Department of Skin and Venereal Diseases
Study Chair: Skaidra Valiukeviciene, Prof. 1Lithuanian University of Health Sciences, Medical Academy, Department of Skin and Venereal Diseases
  More Information

No publications provided

Responsible Party: Evelina Buinauskaite, Principal investigator, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT01541228     History of Changes
Other Study ID Numbers: BE-2-60
Study First Received: February 14, 2012
Last Updated: February 23, 2012
Health Authority: Lithuania: Bioethics Committee

Keywords provided by Lithuanian University of Health Sciences:
actinic keratosis
photodynamic therapy
5-aminolevulinic acid

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Aminolevulinic Acid
 Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013