Efficacy and Safety of Treatment of Actinic Keratoses With Photodynamic Therapy Between MAL Cream and ALA Gel

Launched by FUNDACIÓN INSTITUTO VALENCIANO DE ONCOLOGÍA · Jan 5, 2016

Keywords

ClinConnect Summary

Intraindividual comparative study, to evaluate efficacy and safety of the treatment of actinic keratosis with photodynamic therapy between methyl aminolevulinate cream (MAL) and aminolevulinic acid nanosoma gel (ALA).

MAL cream: is an antineoplastic agent used as a photosensitizer for photodynamic therapy (PDT). The mode of action of methyl aminolevulinate in PDT was shown in the pharmacodynamic (PD) studies. In the target cells,methyl aminolevulinate was converted to photoactive porphyrins, including protoporphyrinIX (PpIX), which are the active photosensitizers. Upon light activation, th...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1 Patient over 18 years old and capable of giving informed consent.
• • 2. Provide at least 5 QA in two symmetrical areas of the face or scalp.
• • 3. Accept the abandonment of sun creams and other creams (retinoic hydroxy acids, emollients, Topical Antibiotics ) in the treatment area during the time of the study.
• • 4. Accept that it will postpone the treatment of other actinic keratosis close to treatment area.
• • 5. Accept to go to scheduled visits. They should answer a questionnaire about epidemiology, history and treatment satisfaction. They will accept a photo of treatment area at each visit.
• Exclusion Criteria:
• • 1. Have any dermatological disease on the treatment zone or around it.
• • 2. Patients who have previously been treated with therapy Photodynamic in targeted areas.
• • 3. Patients with alcohol or drug dependence.
• • 4. Patients who are currently participating in other studies.
• 5. Patients who have received any of the following medications at a time less than the indicated:
• • Systemic chemotherapy in the last 6 months.
• • Retinoids systemic , interferon , immunomodulatory or immunosuppressive , cytotoxic including agents , corticosteroids systemic , in the last month .
• • Ultraviolet A light, Ultraviolet B light, ablative laser, dermabrasion, chemical peels, in the last 6 months.
• • Topical retinoids , topical 5 -fluorouracil in the last month.
• • Cryotherapy , surgical excision, curettage, topical corticosteroids in the last month.