Safety of a formulation containing chitosan microparticles with chamomile

blind controlled clinical trial

Authors

  • Danielle Cristina Garbuio Universidade Anhanguera https://orcid.org/0000-0002-0516-5213
  • Cristina Mara Zamarioli Universidade de São Paulo, Escola de Enfermagem de Ribeirão Preto
  • Maísa Oliveira de Melo Universidade de São Paulo, Faculdade de Ciências Farmacêuticas de Ribeirão Preto
  • Patrícia Maria Berardo Gonçalves Maia Campos Universidade de São Paulo, Faculdade de Ciências Farmacêuticas de Ribeirão Preto
  • Emília Campos de Carvalho Universidade de São Paulo, Escola de Enfermagem de Ribeirão Preto
  • Luis Alexandre Pedro de Freitas Universidade de São Paulo, Faculdade de Ciências Farmacêuticas de Ribeirão Preto

DOI:

https://doi.org/10.1590/1518-8345.2648.3075

Keywords:

Matricaria, Dermatologic Agents, Prevention and Control, Nursing, Clinical Trial, Medicinal Plants

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, nonrandomized, 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).

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Published

2019-03-29

Issue

Vol. 26 (2018)

Section

Original Articles

License

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Including names of authors whose contribution does not fit into the above criteria cannot be justified. Those names can be included in the Acknowledgements section.
 Authors are fully responsible for the concepts disseminated in their manuscripts, which do not necessarily reflect the editors’ and editorial board’s opinion.

 

How to Cite

Safety of a formulation containing chitosan microparticles with chamomile: blind controlled clinical trial. (2019). Revista Latino-Americana De Enfermagem, 26, e3075. https://doi.org/10.1590/1518-8345.2648.3075