Comparison Between 5-aminolevulinic Acid Photodynamic Therapy Versus Cryotherapy for Actinic Keratosis Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Barretos Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01459393
First received: October 12, 2011
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

This study aims to compare in a prospective and randomized way actinic keratosis treatment with 5-aminolevulinic acid photodynamic therapy versus cryotherapy, from the standpoint of therapeutic efficacy, pain, and cosmetic results.


Condition Intervention Phase
Actinic Keratosis
Drug: 5-ALA Photodynamic Therapy
Drug: Cryotherapy with liquid nitrogen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Formulation of 5-aminolevulinic Acid With Dimethylsulfoxide in Photodynamic Therapy for Treatment of Actinic Keratosis

Resource links provided by NLM:


Further study details as provided by Barretos Cancer Hospital:

Primary Outcome Measures:
  • Complete response rates [ Time Frame: 0 months (baseline), 3 months and 6 months ] [ Designated as safety issue: No ]
    Clinical evaluation of treated area.


Secondary Outcome Measures:
  • Visual Analogic Scale Pain Score [ Time Frame: 0 months (baseline), 3 months, 6 months ] [ Designated as safety issue: No ]

    Pain was evaluated with a Visual Analogic Scale (blind) and a graduated scale. It was evaluated at the time 0 and 15 minutes after each intervention (Cryotherapy or PDT): at the first intervention (0 months), and at the second intervention if the residual lesion that indicates a second session (3 months).

    And at the third interwiew (6 months) there was no intervention, but the patients who was submitted to 2 interventions were requested about what intervention was more painfull (the first or the second one).


  • Cosmesis analysis [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]

    Cosmesis was evaluated subjetively by the patient as one of the possibilities: aesthetic outcome awfull, bad, regular, good, excellent.

    Cosmesis was evaluated subjetively also by the researcher as one of the possibilities: aesthetic outcome awfull, bad, regular, good, excellent.

    And there was and objective evaluation of cosmesis by the researcher, the presece or absence of one or more of these criteria: hypochromia, hyperpigmentation,hyperemia, scar.



Enrollment: 137
Study Start Date: November 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5-ALA Photodynamic Therapy
Topical application of a 2mm of thickness layer of 20% 5-aminolevulinic acid (5-ALA) associated with 20% dimethyl sulfoxide (DMSO) and 3% ethylene diamine acid (EDTA) emulsion, over the actinic keratosis lesion and over a 0,5 cm margin around it. After a 4 hours interval under light protection with plastic film and aluminum foil, the light protection and the emulsion is removed. Then the lesion is lightened with a red (630 nm) incoherent LED lamp AKTILITE CL 128 (PhotoCure ASA, Oslo, Norway) with a total light dose of 37J/cm2.After that dressings are done and kept for 24H, and removed at patient home.
Drug: 5-ALA Photodynamic Therapy
Other Name: AKTILITE CL 128 (PhotoCure ASA, Oslo, Norway)
Active Comparator: Cryotherapy with liquid nitrogen
Topical application of liquid nitrogen spray (500ml Cry-ac ® bottle) over the actinic keratosis lesion and over a 0,5 cm margin around it during sufficient time to freeze both the lesion and margin.
Drug: Cryotherapy with liquid nitrogen
Topical application of liquid nitrogen spray (500ml Cry-ac ® bottle) over the actinic keratosis lesion and over a 0,5 cm margin around it during sufficient time to freeze both the lesion and margin.
Other Name: Cry-ac ®

Detailed Description:

Actinic keratosis is a skin lesion induced by chronic sun exposure with a significant prevalence and malignant potential for squamous cell carcinoma, which makes essential its treatment. Today there are several possible therapies, where cryotherapy is usually applied in our practice. Photodynamic therapy (PDT)is another method also widespread for keratosis which involves the administration of a topical precursor drug which produces endogenous photosensitising substances activated by specific light, selectively destroying the diseased tissue. This study aims to evaluate the use the drug formulation for photodynamic therapy 5-aminolevulinic acid (5-ALA) associated with dimethyl sulfoxide, comparing its efficacy with conventional cryotherapy, and also pain and cosmetic results. This project enrolled 137 outpatients from the Department of Cutaneous Oncology of Barretos Cancer Hospital - Pio XII Foundation, with symmetrical and comparable keratosis in their upper limbs. With the same patient as controls, side arm and therapy to be used were randomized: cryotherapy or photodynamic therapy. For cryotherapy was utilized bottles of liquid nitrogen (Cry-ac, 500ml); and for photodynamic therapy was utilized incoherent red light lamp with a total dosis of 37J/cm² . There was one or two sessions of each therapy , at 0 and 3 months; and three assessments for evaluation were done at 0, 3 and 6 months of onset. The evaluations on efficacy were in terms of area regression, and classified as complete response or no response. Pain was assessed by visual analogue scale, and numerical scale. Cosmesis was evaluated with the presence or not, objectively, of hyper, hypopigmentation or scar retraction. Finally, patient's preference regarding utilized therapeutics was noted by the researcher.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 18 years.
  • Patients with actinic keratoses "symmetrical", ie, comparable in the upper limbs ( with the same grade, I, II or III).
  • Patients in accordance with informed consent.

Exclusion Criteria:

  • Patients with concomitant skin diseases, congenital or acquired (albinism, vitiligo, xeroderma, Gorlin, etc.)
  • Immunosuppression (HIV, transplanted patients, etc.)
  • Pregnancy or lactation
  • Patients who do not agree with the informed consent initially or during the protocol.
  • Presence of pigmented lesions near the keratoses.
  • Patients with porphyria.
  • Patients who have undergone less than 2 months with some kind of treatment for keratosis in the upper limbs.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459393

Locations
Brazil
Barretos Cancer Hospital
Barretos, São Paulo, Brazil, 14.784 - 400
Sponsors and Collaborators
Barretos Cancer Hospital
Investigators
Principal Investigator: Catarina Robert, MD Fundação Pio XII - Hospital de Câncer de Barretos
Study Director: René AC Vieira, PHD Fundação Pio XII - Hospital de Câncer de Barretos
  More Information

Publications:

Responsible Party: Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT01459393     History of Changes
Other Study ID Numbers: 5-ALAAK
Study First Received: October 12, 2011
Last Updated: February 28, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Barretos Cancer Hospital:
Actinic keratosis
Photodynamic therapy
5-aminolevulinic acid
Cryotherapy

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Aminolevulinic Acid
Dimethyl Sulfoxide
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Cryoprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on April 17, 2014