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Stability evaluation and clinical-laboratory study to verify and compare the efficacy and safety of retinoic acid at its daily use 0.05% and serial peeling 5.0%

Grant number: 13/01118-5
Support type:Regular Research Grants
Duration: October 01, 2013 - December 31, 2015
Field of knowledge:Health Sciences - Pharmacy - Pharmaceutical Technology
Principal researcher:Gislaine Ricci Leonardi
Grantee:Gislaine Ricci Leonardi
Home Institution: Faculdade de Ciências Farmacêuticas (FCF). Universidade Estadual de Campinas (UNICAMP). Campinas , SP, Brazil
Assoc. researchers:Ediléia Bagatin ; Paulo César Pires Rosa


The effects of retinoic acid topical use include: proliferation and differentiation of epidermal cells, with increase of epidermal thickness, high glycosaminoglycan production, which provides water retention, resulting in hydration, increases pro-collagen I and III synthesis by fibroblasts and reduces metalloproteinase synthesis in keratinocytes and fibroblasts.The topical use of retinoic acid creams consists the major treatment to skin aging, mainly in photoaging. However, its use as superficial chemical peeling agent in formulations with high concentrations requires efficacy and safe results. There are controversies about advantage of peeling retinoic acid in relation about continuous use, with low concentration. This research will be experimental and therapeutic intervention. The experience will have stages. At the first one the cutaneous permeation of retinoic acid will be compared in different pharmaceutical forms (cream and hydroalcoholic solution) and in different concentrations (0.05% and 5%), applied to the skin for the human forearm and pig earn skin. On the second stage the therapeutic intervention clinic study will be performed, randomized, comparative and double-blind to verify the efficacy and safety of retinoic acid base, which will select at the first step of the study, containing 0.05% or as agent for serial superficial peelings at 5% concentration in the treatment of forearm advanced photoaging. The research will still evaluate the formulations stability and the protection of pack against ultraviolet radiation. (AU)

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Scientific publications (4)
(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)
SUMITA, J. M.; MIOT, H. A.; SOARES, J. L. M.; RAMINELLI, A. C. P.; PEREIRA, S. M.; OGAWA, M. M.; PICOSSE, F. R.; GUADANHIM, L. R. S.; ENOKIHARA, M. M. S. S.; LEONARDI, G. R.; BAGATIN, E. Tretinoin (0.05% cream vs. 5% peel) for photoaging and field cancerization of the forearms: randomized, evaluator-blinded, clinical trial. JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY, v. 32, n. 10, p. 1819-1826, OCT 2018. Web of Science Citations: 3.
POMPEU RAMINELLI, ANA CLAUDIA; ROMERO, VALERIA; SEMREEN, MOHAMMAD H.; LEONARDI, GISLAINE RICCI. Nanotechnological Advances for Cutaneous Release of Tretinoin: An Approach to Minimize Side Effects and Improve Therapeutic Efficacy. Current Medicinal Chemistry, v. 25, n. 31, p. 3703-3718, 2018. Web of Science Citations: 2.
CARVALHO, P. R. S.; SUMITA, J. M.; SOARES, J. L. M.; SANUDO, A.; BAGATIN, E. Forearm skin aging: characterization by instrumental measurements. International Journal of Cosmetic Science, v. 39, n. 5, p. 564-571, OCT 2017. Web of Science Citations: 0.
MONTEIRO E SILVA, SILAS ARANDAS; FIORAMONTI CALIXTO, GIOVANA MARIA; CAJADO, JULIANA; ANTUNES DE CARVALHO, PATRICIA CABALLIERI; RODERO, CAMILA FERNANDA; CHORILLI, MARLUS; LEONARDI, GISLAINE RICCI. Gallic Acid-Loaded Gel Formulation Combats Skin Oxidative Stress: Development, Characterization and Ex Vivo Biological Assays. POLYMERS, v. 9, n. 9 SEP 2017. Web of Science Citations: 0.

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