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Completed

NCT Number: NCT01459393

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Barretos Cancer Hospital

Barretos, São Paulo, 14.784 - 400, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

5-ALA Photodynamic Therapy

Drug

Other names: AKTILITE CL 128 (PhotoCure ASA, Oslo, Norway)

Cryotherapy with liquid nitrogen

Drug

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 names: Cry-ac ®

Primary outcomes

  1. Complete response rates

    Time frame: 0 months (baseline), 3 months and 6 months

    Clinical evaluation of treated area.

Secondary outcomes

  1. Visual Analogic Scale Pain Score

    Time frame: 0 months (baseline), 3 months, 6 months

    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).

  2. Cosmesis analysis

    Time frame: 3 months, 6 months

    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.

Sponsors and collaborators

Lead sponsor

Barretos Cancer Hospital

Other

Registry information

Official study title

Evaluation of the Formulation of 5-aminolevulinic Acid With Dimethylsulfoxide in Photodynamic Therapy for Treatment of Actinic Keratosis

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 25, 2011
Registry last updated
Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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