Trial Information

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

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.