Actinic Keratosis
Conditions
Keywords
Actinic keratosis, Photodynamic therapy, 5-aminolevulinic acid, Cryotherapy
Brief summary
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.
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.
Interventions
DRUG5-ALA Photodynamic Therapy
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.
Sponsors
Barretos Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rates | 0 months (baseline), 3 months and 6 months | Clinical evaluation of treated area. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogic Scale Pain Score | 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). |
| Cosmesis analysis | 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. |
Countries
Brazil
Outcome results
None listed