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Clinical, laboratorial and quality of life study to evaluate efficacy and safety of oral isotretinoin for the treatment of cutaneous photodamage

Grant number: 09/51271-9
Support Opportunities:Regular Research Grants
Duration: August 01, 2009 - July 31, 2011
Field of knowledge:Health Sciences - Medicine - Medical Clinics
Principal Investigator:Ediléia Bagatin
Grantee:Ediléia Bagatin
Host Institution: Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil


Oral isotretinoin is one of retinoids, compounds derived from vitamin A which interferes in gene expression related to keratinocytes, sebocytes and fibroblasts proliferation, differentiation and function. It is the gold standard treatment for acne for the last 30 years. Off-label indications have been reported as: seborrhea, photoaging and non-melanoma skin cancer prevention. This drug is considered safe despite adverse effects as mucocutaneous and risk for alterations in lipid metabolism and liver function. The major problem is teratogenicity thus pregnancy avoidance is necessary during and until one month after treatment. This is an interventional, randomized, comparative (parallel groups) and evaluator-blind study, comprising 20 men and women, aged 50 to 75 years old and presenting photodamage signs on face and forearms. Main objective will be evaluation of clinical, epidermal and dermal histological and immunohistochemical effects. Secondary objectives are evaluation of aesthetic benefit and safety. Doses will be 20 mg every other day, for 6 months. Comparison will be done with another topical tretinoid, tretinoin in cream which is gold standard for photoaging- All patients will also use sunscreen. Efficacy evaluation will be clinical, photographic, quality of life and histological. All subjects will be submitted to two skin biopsies on left forearm followed by histopathological and immunohistochemical (for p53 protein, apoptosis and collagens I and III) examinations. Biomarkers reduction, as p53 protein and apoptosis, might corroborate for the hypothesis of skin cancer prevention. Safety will be evaluated by adverse events observation and laboratorial tests for subjects using oral isotretinoin. Data will be submitted to statistical analysis. (AU)

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Scientific publications
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
BAGATIN, EDILEIA; GUADANHIM, LILIA R. S.; ENOKIHARA, MILVIA M. S. S.; SANUDO, ADRIANA; TALARICO, SERGIO; MIOT, HELIO A.; GIBSON, LAWRENCE. Low-dose oral isotretinoin versus topical retinoic acid for photoaging: a randomized, comparative study. INTERNATIONAL JOURNAL OF DERMATOLOGY, v. 53, n. 1, p. 114-122, . (09/51271-9)

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