RESUMEN
BACKGROUND: Although the scientific literature associates mature skin with dry skin and the secretion of sebum on the face decreases over the years, in tropical countries, such as Brazil, mature skin can still present oily characteristics. Thus, the knowledge of the hydrophilic characteristics of mature skin is fundamental to help the development of more effective treatments for this skin type. In this context, the study aimed to evaluate the hydrophilic characteristics and the clinical efficacy of a cosmetic formulation for mature skin added with alfalfa and lentil extracts by using biophysical and skin imaging techniques. METHODS: Twenty-eight healthy females aged between 45 and 59 years were enrolled. Measurements of the stratum corneum water content, sebum content, transepidermal water loss, skin microrelief, and pores count were performed before and after the 28-day formulation application. RESULTS: The mature skin presented as oily with wrinkles and pores. The proposed formulation significantly reduced the sebum content and the number of fine and large pores and improved skin microrelief and hydration after a 28-day period of the application when compared to the vehicle. CONCLUSIONS: The proposed formulation was effective in oily mature skin treatment, improving its general skin aging and oiliness conditions, and reducing pores count in just 28 days.
RESUMEN
OBJECTIVE: to evaluate the safety of a topical formulation containing chamomile microparticles coated with chitosan in the skin of healthy participants. METHOD: phase I blind, controlled, non-randomized, single-dose clinical trial with control for skin, base formulation, and formulation with microparticles. The variables analyzed were irritation and hydration by the Wilcoxon and Kruskall-Wallis tests. RESULTS: the study started with 35 participants with a mean age of 26.3 years. Of these, 30 (85.71%) were female, 29 (82.90%) were white skinned and 32 (91.40%) had no previous pathologies. One participant was removed from the study reporting erythema at the site of application, and four other participants for not attending the last evaluation. In the 30 participants who completed the study, the tested formulation did not cause erythema, peeling, burning, pruritus or pain; there was an improvement in cutaneous hydration in the site of application of the formulation with microparticles. In the evaluation of the barrier function, there was an increase in transepidermal water loss in all sites. CONCLUSION: the formulation with chamomile microparticles is safe for topical use, not causing irritation and improving skin hydration over four weeks of use. Its effects on barrier function need further investigation. No. RBR-3h78kz in the Brazilian Registry of Clinical Trials (ReBEC).
Asunto(s)
Manzanilla/química , Quitosano/administración & dosificación , Extractos Vegetales/administración & dosificación , Piel/efectos de los fármacos , Administración Tópica , Adolescente , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Método Simple Ciego , Cuidados de la Piel/métodos , Enfermedades de la Piel/prevención & control , Fenómenos Fisiológicos de la Piel , Pérdida Insensible de Agua , Adulto JovenRESUMEN
ABSTRACT Objective: to evaluate the safety of a topical formulation containing chamomile microparticles coated with chitosan in the skin of healthy participants. Method: phase I blind, controlled, non-randomized, single-dose clinical trial with control for skin, base formulation, and formulation with microparticles. The variables analyzed were irritation and hydration by the Wilcoxon and Kruskall-Wallis tests. Results: the study started with 35 participants with a mean age of 26.3 years. Of these, 30 (85.71%) were female, 29 (82.90%) were white skinned and 32 (91.40%) had no previous pathologies. One participant was removed from the study reporting erythema at the site of application, and four other participants for not attending the last evaluation. In the 30 participants who completed the study, the tested formulation did not cause erythema, peeling, burning, pruritus or pain; there was an improvement in cutaneous hydration in the site of application of the formulation with microparticles. In the evaluation of the barrier function, there was an increase in transepidermal water loss in all sites. Conclusion: the formulation with chamomile microparticles is safe for topical use, not causing irritation and improving skin hydration over four weeks of use. Its effects on barrier function need further investigation. No. RBR-3h78kz in the Brazilian Registry of Clinical Trials (ReBEC).
RESUMO Objetivo: avaliar a segurança de uma formulação tópica, contendo micropartículas de camomila revestidas com quitosana, na pele de participantes saudáveis. Método: ensaio clínico fase I, mascarado, controlado, não aleatorizado, de dose única, com controles da pele, da base da formulação e da formulação com micropartículas. As variáveis analisadas foram irritação e hidratação por meio dos testes de Wilcoxon e Kruskall-Wallis. Resultados: iniciaram o estudo 35 participantes com idade média de 26,3 anos. Destes, 30 (85,71%) eram do sexo feminino, 29 (82,90%) brancos e 32 (91,40%) sem patologias prévias. Um participante foi descontinuado por referir eritema no local de aplicação e quatro por não comparecerem à última avaliação. Nos 30 participantes que finalizaram o estudo, a formulação teste não causou eritema, descamação, ardor, prurido ou dor; houve melhora na hidratação cutânea no local de aplicação da formulação com as micropartículas. Na avaliação da função barreira houve aumento da perda transepidérmica de água em todos os locais. Conclusão: a formulação com micropartículas de camomila é segura para o uso tópico, não provocando irritação e melhorando a hidratação cutânea ao longo de quatro semanas de uso. Seus efeitos na função barreira devem ser melhor estudados. N° RBR-3h78kz no Registro Brasileiro de Ensaios Clínicos (ReBEC).
RESUMEN Objetivo: evaluar la seguridad de una formulación tópica, conteniendo micropartículas de manzanilla revestidas con quitosano, en la piel de participantes sanos. Método: ensayo clínico fase I, enmascarado, controlado, no aleatorizado, de dosis única, con controles de la piel, de la base de la formulación y de la formulación con micropartículas. Las variables analizadas fueron irritación e hidratación por medio de los tests de Wilcoxon y Kruskall-Wallis. Resultados: iniciaron el estudio 35 participantes con edad media de 26,3 años. De esos, 30 (85,71%) eran del sexo femenino, 29 (82,90%) blancos y 32 (91,40%) sin patologías previas. Un participante fue descontinuado por referir eritema en el local de aplicación y cuatro por no comparecer a la última evaluación. En los 30 participantes que finalizaron el estudio, la formulación test no causó eritema, descamación, ardor, prurito o dolor; hubo mejora en la hidratación cutánea en el local de aplicación de la formulación con las micropartículas. En la evaluación de la función barrera hubo aumento de la pérdida transepidérmica de agua en todos los locales. Conclusión: la formulación con micropartículas de manzanilla es segura para el uso tópico, no provocando irritación y mejorando la hidratación cutánea a lo largo de cuatro semanas de uso. Sus efectos en la función barrera deben ser mejor estudiados. N° RBR-3h78kz en el Registro Brasilero de Ensayos Clínicos (ReBEC).