Randomized and comparative clinical trial to evaluate efficacy, safety and period of remission of low-dose oral isotretinoin as compared to doxicyclin cloridrate in the treatment of papule-pustular rosacea

• Grant number: 15/18924-0
• Support Opportunities: Regular Research Grants
• Start date: February 01, 2017
• End date: July 31, 2019
• 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
• Associated researchers: Daniela Aidar Monteiro da Costa ; Denise de Freitas ; Fabíola Rosa Picosse ; Hélio Amante Miot ; Laura Pires da Cunha ; Milvia Maria Simões e Silva Enokihara

Abstract

Rosacea is a chronic inflammatory disease that is relatively common, characterized by intermittent periods of exacerbation and remission. It is manifested clinically by recurrent episodes of flushing, erythema, telangiectasia, papules and pustules. In severe cases there is the late emergence of fimas. Ocular involvement is common. To date, there is no cure for rosacea. The disease adversely affects the quality of life of individuals. Its pathogenesis is not yet completely understood. It is believed in genetic predisposition, vascular disorders and participation of innate immunity. The antibiotic doxycycline hydrochloride is widely used and this treatment is considered safe and effective for the control of rosacea. Its therapeutic effect is mainly based on its anti-inflammatory action. Oral isotretinoin, analogue of vitamin A, is a potent inhibitor of the sebaceous glands with significant anti-inflammatory properties by modulating toll-like receptor 2 (TLR-2). The effectiveness of oral isotretinoin for severe rosacea has been reported in 1980. Recent systematic review indicates the possibility of its use in a low dose, in the case of rosacea resistant to other treatments. Methods: Study of therapeutic intervention, randomized, comparative. Will be included 60 participants with moderate to severe papulopustular rosacea with or without ocular disease randomized into two treatment groups: Group ISO: oral isotretinoin at a dose of 0.3 to 0.4 mg / kg / day for 16 weeks; Doxy Group: doxycycline hydrochloride at a dose 100 mg / day for 16 weeks. All will be subject to a preliminary eye examination in order to detect ocular involvement and will continue to be accompanied by Ophthalmology during the study. Skin biopsies before and at the end of treatment will be executed in the paranasal region to histological and immunohistochemical examinations to assess the epidermal and dermal aspects and the expression of skin markers: TLR-2, VEGF, CD 31, TRPV-1 , cathelicidins, and iNOS. After treatment completion participants will be followed for another 16 weeks to evaluate the relapse. All participants fill generic questionnaire for assessing quality of life in dermatology and ophthalmology before and after treatments. (AU)

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)

TANNUS, FLAVIA CISI; PICOSSE, FABIOLA ROSA; SOARES, JULIANA MARQUES; BAGATIN, EDILEIA. Rosacea-specific quality of life questionnaire: translation, cultural adaptation and validation for Brazilian Portuguese. ANAIS BRASILEIROS DE DERMATOLOGIA, v. 93, n. 6, p. 836-842, NOV-DEC 2018. (15/18924-0)