BACKGROUND:Rosacea is a photoaggravated dermatosis responsive to treatment with topical and oral antibiotics. A formulation combining metronidazole 1% cream with sunscreen SPF 15 was developed for the treatment of rosacea. OBJECTIVE: The objective of this study was to determine the safety and efficacy of a formulation combining metronidazole 1% cream with sunscreen SPF 15 in the treatment of moderate to severe rosacea. METHODS:One hundred and twenty patients with moderate to severe rosacea were enrolled for a randomized, placebo-controlled (vehicle containing sunscreen with SPF 15), double-blind study. Study cream was applied twice daily to the entire face over a 12-week period. RESULTS: Treatment with metronidazole 1% cream with sunscreen SPF 15 resulted in significant improvement (p <0.05) in inflammatory lesion count, erythema and telangiectasiae scores, and investigator and patient global assessment scores compared with baseline and placebo. Adverse reactions related to study medication were typically mild, occurred at the site of application, and were reversible. There was no difference between the safety profiles of metronidazole 1% cream with sunscreen SPF 15 and placebo. CONCLUSIONS: The combined topical formulation of metronidazole 1% cream with sunscreen SPF 15 was an effective, well-tolerated topical agent for the treatment of moderate to severe rosacea.
RCT Entities:
BACKGROUND:Rosacea is a photoaggravated dermatosis responsive to treatment with topical and oral antibiotics. A formulation combining metronidazole 1% cream with sunscreen SPF 15 was developed for the treatment of rosacea. OBJECTIVE: The objective of this study was to determine the safety and efficacy of a formulation combining metronidazole 1% cream with sunscreen SPF 15 in the treatment of moderate to severe rosacea. METHODS: One hundred and twenty patients with moderate to severe rosacea were enrolled for a randomized, placebo-controlled (vehicle containing sunscreen with SPF 15), double-blind study. Study cream was applied twice daily to the entire face over a 12-week period. RESULTS: Treatment with metronidazole 1% cream with sunscreen SPF 15 resulted in significant improvement (p <0.05) in inflammatory lesion count, erythema and telangiectasiae scores, and investigator and patient global assessment scores compared with baseline and placebo. Adverse reactions related to study medication were typically mild, occurred at the site of application, and were reversible. There was no difference between the safety profiles of metronidazole 1% cream with sunscreen SPF 15 and placebo. CONCLUSIONS: The combined topical formulation of metronidazole 1% cream with sunscreen SPF 15 was an effective, well-tolerated topical agent for the treatment of moderate to severe rosacea.
Authors: Sérgio Schalka; Denise Steiner; Flávia Naranjo Ravelli; Tatiana Steiner; Aripuanã Cobério Terena; Carolina Reato Marçon; Eloisa Leis Ayres; Flávia Alvim Sant'anna Addor; Helio Amante Miot; Humberto Ponzio; Ida Duarte; Jane Neffá; José Antônio Jabur da Cunha; Juliana Catucci Boza; Luciana de Paula Samorano; Marcelo de Paula Corrêa; Marcus Maia; Nilton Nasser; Olga Maria Rodrigues Ribeiro Leite; Otávio Sergio Lopes; Pedro Dantas Oliveira; Renata Leal Bregunci Meyer; Tânia Cestari; Vitor Manoel Silva dos Reis; Vitória Regina Pedreira de Almeida Rego Journal: An Bras Dermatol Date: 2014 Nov-Dec Impact factor: 1.896
Authors: Esther J van Zuuren; Zbys Fedorowicz; Ben Carter; Mireille M D van der Linden; Lyn Charland Journal: Cochrane Database Syst Rev Date: 2015-04-28
Authors: E J van Zuuren; Z Fedorowicz; J Tan; M M D van der Linden; B W M Arents; B Carter; L Charland Journal: Br J Dermatol Date: 2019-03-10 Impact factor: 9.302