Safety of a formulation containing chitosan microparticles with chamomile: blind controlled clinical trial

Rev. Latino-Am. Enfermagem Original Article 2018;26:e3075 DOI: 10.1590/1518-8345.2648.3075 www.eerp.usp.br/rlae Safety of a formulation containing chitosan microparticles with chamomile: blind controlled clinical trial* Danielle Cristina Garbuio1 Cristina Mara Zamarioli2 Maísa Oliveira de Melo3 Patrícia Maria Berardo Gonçalves Maia Campos3 Emília Campos de Carvalho2 Luis Alexandre Pedro de Freitas3 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). Descriptors: Matricaria; Dermatologic Agents; Prevention and Control; Nursing; Clinical Trial; Medicinal Plants. * Paper extracted from doctoral dissertation “Prevention of skin injuries: development of a topical formulation of chitosan microparticles with Chamomilla recutita (L.) rauschert and preliminary studies of its use”, presented to Escola de Enfermagem de Ribeirão Preto, Universidade de São Paulo, PAHO/WHO Collaborating Centre for Nursing Research Development, Ribeirão Preto, SP, Brazil. Supported by Conselho Nacional de Desenvolvimento Científico e Tecnológico, Brazil. 1 Universidade Anhanguera, Valinhos, SP, Brazil. 2 Universidade de São Paulo, Escola de Enfermagem de Ribeirão Preto, PAHO/WHO Collaborating Centre for Nursing Research Development, Ribeirão Preto, SP, Brazil. 3 Universidade de São Paulo, Faculdade de Ciências Farmacêuticas de Ribeirão Preto, Ribeirão Preto, SP, Brazil. How to cite this article Garbuio DC, Zamarioli CM, Melo MO, Campos PMBGM, Carvalho EC, Freitas LAP. Safety of a formulation containing chitosan microparticles with chamomile: blind controlled clinical trial. Rev. Latino-Am. Enfermagem. 2018;26:e3075. [Access ___ __ ____]; Available in: ___________________. DOI: http://dx.doi.org/10.1590/1518-8345.2648.3075. month day year URL Rev. Latino-Am. Enfermagem 2018;26:e3075. 2 Introduction potential in the treatment of skin lesions, with positive results in cicatrization and inflammatory response(24-28). The skin, as the interface of the human body with This polymer was also used to coat microparticles the external environment, carries part of our identity: containing endothelial and epidermal growth factors, it provides information about our age, genetics, health with positive results in improving the cicatrization status, lifestyle and even our emotional state(1). The process(29), and also as a coating of microparticles skin has different roles, among them, the function of capable of capturing and expanding specific cells in order barrier, thermoregulation, vitamin D synthesis and also to accelerate the anti-inflammatory and cicatrization protection of the body against harmful agents(2-3). processes(30). Currently, there is a growing interest on skin care Despite all the potentialities of chitosan-coated products and their protective and healing properties, microparticles and the therapeutic properties of especially those with botanical extracts(4). Among the chamomile, no studies with these compounds were latter, Chamomilla recutita (L.) rauschert (chamomile) identified in the literature. These microparticles are is a popular plant(5) which has its use as a phytotherapic incorporated in lanolin-based formulation, a safe released by the National Agency of Sanitary Surveillance substance for topical applications that incorporates (ANVISA)(6). Chamomile has flavonoids, among which various bioactive agents(31). apigenin and apigenin-7-glycoside are the most abundant(7). In different studies, these substances have proved to have antimicrobial(8), analgesic(9), antiinflammatory(6,8,10-11), cicatrizant(12-13), antitumor(14-15) and immunomodulator(16) potential. Moreover, the antioxidant blend present in chamomile extract is effective in reducing free radicals and brings potential benefits when used in skin formulations by reducing water loss, improving hydration, and aiding the maintenance of the barrier function(4). The risks associated with the use of this plant are small and are related to the reduction of platelet In view of the above, a study was carried out to evaluate the safety of the topical formulation containing chitosan-coated Chamomilla recutita (L.) Rauschert microparticles for application on the skin of healthy volunteers evaluating the following variables: erythema, variation in the amount of melanin, desquamation, burning, pruritus, pain and alterations in cutaneous hydration. The hypothesis was that the use of this formulation would be safe for cutaneous application over four weeks of use. Method aggregation(17) and anaphylactic reactions to people sensitive to its components(18). However, a recent study Blind, controlled, non-randomized, single-dose that evaluated allergic reactions to herbal compounds Phase I clinical trial in which a low dose with biological over the last 27 years found no reports related to activity of the active ingredient was administered(32). Chamomilla recutita (L.) rauschert(19). Extraction and microencapsulation methodologies Despite the potential of apigenin and apigenin-7- developed and validated in a previous study were applied glycoside, they have low stability(15,20-22). An alternative for the development of the microparticles used in this to improve this issue is the use of controlled release study(21). Quality tests of the plant acquired according systems. The pharmaceutical sector, in line with to the guidelines of the Brazilian Pharmacopoeia(34) were technological developments, has gradually improved the carried out in another study developed by the main processes of obtaining different products and invested in author, as well as preliminary permeation and st (...truncated)