Clinical evaluation of paraprobiotic-associated Bifidobacterium lactis CCT 7858 anti-dandruff shampoo efficacy: A randomized placebo-controlled clinical trial.

OBJECTIVE: The microbiome plays an important role in a wide variety of skin disorders. Hence, dysbiosis in the skin and/or gut microbiome is associated with an altered immune response, promoting the development of skin diseases, such as atopic dermatitis, psoriasis, acne vulgaris and dandruff. Studies have shown that paraprobiotics may be promising for the treatment of skin disorders through microbiota modulation and immunomodulation. So, the objective is to develop an anti-dandruff formulation using a paraprobiotic (Neoimuno) as active ingredient. METHODS: Randomized, double-blind, placebo-controlled clinical trial was performed in patients who had any degree of dandruff. A total of 33 volunteers were recruited and randomly divided into two groups: placebo or treated. (1% Neoimuno). The ingredient used was Neoimuno (Bifidobacterium lactis strain CCT 7858). Combability analysis and perception questionnaire were applied before and after treatment. Statistical analyses were performed. RESULTS: No adverse effects were reported by patients throughout the study. Through the combability analysis, a significant decrease in the number of particles was verified after 28 days of shampoo use. Regarding perception, there was a significant difference for the cleaning variables and improvement of the general appearance 28 days after the intervention. There were no significant differences for the itching and scaling parameters, as well as the perception parameters at 14 days. DISCUSSION: Topical application of the paraprobiotic shampoo containing 1% Neoimuno was able to significantly improve the feeling of cleanliness and general aspects of dandruff, in addition to reducing scalp flakiness. Thus, with the results obtained through the clinical trial, Neoimuno presents itself as a natural, safe and effective ingredient in the treatment of dandruff. The efficacy of Neoimuno in dandruff was visible within 4 weeks.

OBJECTIF: Le microbiome joue un rôle important dans une grande variété de troubles cutanés. Ainsi, la dysbiose du microbiome cutané et/ou intestinal est associée à une réponse immunitaire altérée, favorisant le développement de maladies cutanées, telles que la dermatite atopique, le psoriasis, l'acné vulgaire et les pellicules. Des études ont montré que les paraprobiotiques peuvent être prometteurs pour le traitement des troubles cutanés par la modulation du microbiote et l'immunomodulation. Ainsi, l'objectif est de développer une formulation antipelliculaire utilisant un paraprobiotique (Neoimuno) comme principe actif. MÉTHODES: Un essai clinique randomisé, en double aveugle et contrôlé par placebo a été réalisé chez des patients présentant des pellicules de n'importe quel degré. Au total, 33 volontaires ont été recrutés et divisés au hasard en deux groupes: placebo ou traité. (1% Neoimuno). L'ingrédient utilisé était le Neoimuno (souche Bifidobacterium lactis CCT 7858). Une analyse de combabilité et un questionnaire de perception ont été appliqués avant et après le traitement. Des analyses statistiques ont été effectuées. RÉSULTATS: Aucun effet indésirable n'a été signalé par les patients tout au long de l'étude. Grâce à l'analyse de combabilité, une diminution significative du nombre de particules a été vérifiée après 28 jours d'utilization du shampooing. Concernant la perception, il y avait une différence significative pour les variables de nettoyage et d'amélioration de l'aspect général 28 jours après l'intervention. Il n'y avait pas de différences significatives pour les paramètres de démangeaison et de desquamation, ainsi que les paramètres de perception à 14 jours. DISCUSSION: L'application topique du shampooing paraprobiotique contenant 1% de Neoimuno a pu améliorer significativement la sensation de propreté et les aspects généraux des pellicules, en plus de réduire la desquamation du cuir chevelu. Ainsi, avec les résultats obtenus grâce à l'essai clinique, Neoimuno se présente comme un ingrédient naturel, sûr et efficace dans le traitement des pellicules. L'efficacité de Neoimuno sur les pellicules a été visible en 4 semaines.

A primer to natural hair care practices in black patients.

Natural hairstyles have increased in popularity in the United States among individuals of African and Afro-Caribbean descent. Dermatologists should be aware of general principles of natural hair care in this patient population, including basic hair care terminology, types of natural hairstyles, methods of washing, and product selection. A basic knowledge of natural hair care practices in black patients will assist dermatologists in the management and treatment of many conditions associated with traumatic hairstyling in this patient population.

Treatment of pityriasis versicolor with topical application of essential oil of Cymbopogon citratus (DC) Stapf - therapeutic pilot study.

BACKGROUND: Pityriasis versicolor is a fungal infection caused by Malassezia spp. that has frequent relapses. OBJECTIVES: The main objective of this research was to perform phase I and II clinical studies, using formulations containing essential oil of Cymbopogon citratus in patients with pityriasis versicolor. METHODS: Phase I study included twenty volunteers to ascertain the safety of the formulations. In phase II, 47 volunteers randomly received essential oil formulations at 1.25 µL/mL concentration, for forty days. The shampoo should be applied three times a week and the cream twice a day. A control group in phase II, consisting of 29 volunteers, received the same formulations but with 2% ketoconazole as the active ingredient. RESULTS: No significant adverse events were observed in volunteers during Phase I. In Phase II, 30 (63.83%) volunteers using essential oil and 18 (62.07%) using ketoconazole remained until the end of the study. We observed a predominance of lesions in disseminated form, with M. sympodialis detected as the predominant agent identified in cultures. After 40 days of treatment, the rate of mycological cure was 60% (p <0.05) for the group treated with essential oil of C. citratus and over 80% (p <0.05) for the group treated with ketoconazole formulations. CONCLUSIONS: Notwithstanding the safety and antifungal effects observed in this study after application of formulations containing the essential oil of C. citratus, further studies with larger populations should be performed to confirm the actual potential of these formulations in the treatment of patients with Pityriasis versicolor.

Treatment of pityriasis versicolor with topical application of essential oil of Cymbopogon citratus (DC) Stapf - therapeutic pilot study / Tratamento de pitiríase versicolor com aplicação tópica do óleo essencial de Cymbopogon citratus (DC) Stapf - estudo terapêutico piloto

BACKGROUND: Pityriasis versicolor is a fungal infection caused by Malassezia spp. that has frequent relapses. OBJECTIVES: The main objective of this research was to perform phase I and II clinical studies, using formulations containing essential oil of Cymbopogon citratus in patients with pityriasis versicolor. METHODS: Phase I study included twenty volunteers to ascertain the safety of the formulations. In phase II, 47 volunteers randomly received essential oil formulations at 1.25 μL/mL concentration, for forty days. The shampoo should be applied three times a week and the cream twice a day. A control group in phase II, consisting of 29 volunteers, received the same formulations but with 2% ketoconazole as the active ingredient. RESULTS: No significant adverse events were observed in volunteers during Phase I. In Phase II, 30 (63.83%) volunteers using essential oil and 18 (62.07%) using ketoconazole remained until the end of the study. We observed a predominance of lesions in disseminated form, with M. sympodialis detected as the predominant agent identified in cultures. After 40 days of treatment, the rate of mycological cure was 60% (p <0.05) for the group treated with essential oil of C. citratus and over 80% (p <0.05) for the group treated with ketoconazole formulations. CONCLUSIONS: Notwithstanding the safety and antifungal effects observed in this study after application of formulations containing the essential oil of C. citratus, further studies with larger populations should be performed to confirm the actual potential of these formulations in the treatment of patients with Pityriasis versicolor. .

FUNDAMENTOS: Pitiríase versicolor é uma micose causada pela Malassezia spp., e que apresenta frequentes recidivas. OBJETIVOS: Este trabalho objetivou realizar estudos clínicos de fase I e II, para essa patologia, com óleo essencial de Cymbopogon citratus. MÉTODOS: Na fase I, participaram vinte voluntários para averiguar a segurança das formulações. Na fase II, 47 voluntários receberam as formulações do óleo essencial a 1,25 μL/mL, as quais deveriam ser utilizadas por quarenta dias, sendo o xampu três vezes por semana e o creme duas vezes ao dia. Um grupo controle na fase II, constituído por 29 voluntários recebeu as mesmas formulações, com cetoconazol a 2%. RESULTADOS: Verificada a segurança das formulações com a finalização da fase I, onde nenhuma reação adversa significativa foi observada nos indivíduos sadios, conduziu-se a fase II. Nesta segunda fase, 30 (63,83%) voluntários utilizando óleo essencial e 18 (62,07%) cetoconazol permaneceram até o final do estudo. Observaram-se nos pacientes com pitiríase versicolor predomínio de lesões na forma disseminada e M. sympodialis foi o agente predominante identificado em cultura. Após 40 dias de tratamento, obteve-se um percentual de cura micológica de 60% (p < 0,05) para o grupo tratado com óleo essencial de C. citratus e superior a 80% (p < 0,05) para o grupo tratado com cetoconazol. CONCLUSÕES: Apesar da segurança e efeito antifúngico observados após aplicação das formulações contendo óleo essencial de C. citratus, outros estudos com maior número de portadores de pitiríase versicolor precisam ser realizados para confirmar o real potencial destas f...

Cromatografia líquida de alta eficiência aplicada ao controle da qualidade de cis-permetrina em loção capilar / High-performance liquid chromatography applied to the control of the quality of cis-permethrin in capillary lotion

Doenças ectoparasitárias como a escabiose, a pediculose, a tungíase e a larva migrans cutânea são epidêmicas em inúmeras comunidades carentes no Brasil e seu controle efetivo é um desafio para a Saúde Pública. Embora a permetrina seja um dos medicamentos aprovados pelo Food and Drug Administration para o tratamento da pediculose, não há um método oficial disponível para a realização do controle da qualidade deste produto em loção capilar de uso humano. Assim, o objetivo deste trabalho foi desenvolver e validar um método analítico sensível, específico, preciso e exato para esta análise, seguindo os critérios descritos na Resolução no 899/2003 da Agência Nacional de Vigilância Sanitária (ANVISA). A cromatografia líquida de alta eficiência (HPLC) com detector diode array (λ = 235nm) foi empregada na determinação de cis-permetrina em loção capilar, visando implementar um sistema de controle da qualidade em laboratórios analíticos. A cis-permetrina e a substância utilizada como padrão interno (PI), o cloridrato de nafazolina, foram separados em coluna analítica S5W (4,6 x 150mm) Waters Spherisorb® e eluídos isocraticamente (fluxo de 1,2mL/min). A cis-permetrina e o PI foram caracterizados pelos tempos de retenção de 1,52 e 8,66 minutos respectivamente. O método mostrou-se linear na faixa de 1,6 a 127,5µg/mL e, nos estudos de precisão intra e interensaio, foram obtidos coeficientes de variação inferiores a 5%, calculados a partir dos resultados. A exatidão média do método foi de 103%. Os limites de detecção e quantificação foram 1,6µg/mL e 2,4µg/mL respectivamente. A cis-permetrina manteve-se estável por 24 horas à temperatura ambiente; por 15 dias a 4ºC e 30 dias a -20ºC. O método mostrou-se simples e apropriado para a determinação de cis-permetrina em loção capilar.

Parasitic skin diseases such as scabies, pediculosis, tungiasis, and cutaneous larva migrans are epidemic in numerous communities in Brazil and their effective control is a major challenge to public health. Permethrim is one of the medications approved by the Food and Drug Administration to treat pediculosis. However, official methods of quality control for permethrin's use as hair lotion are currently unavailable. Thus, a specific and accurate method was validated using high performance liquid chromatography (HPLC) with a diode array detector (λ = 235 nm) in order to determine cis-permethrin in hair lotion, aiming to establish a systemof quality control in analytical laboratories. Cis-permethrin and naphazolinechloride (internal standard - IS) were separated in an analytical S5W column (4.6 x 150 mm) Waters Spherisorb® and isocratically eluted (flow rate =1.2 mL/min). Cis-permethrin and IS were characterized by their retention times: 1.52 and 8.66 minutes, respectively. The accuracy of this method was 103%. A linear range was detected from 1.6 to 127.5µg/ml and CV < 5% calculated from intra and inter-essay precision results. LOD and LOQ were 1.6µg/mL and 2.4µg/mL, respectively. Cis-permethrin remained stable for 24 hours at room temperature; for 15 days at 4ºC and 30 days at -20ºC. The method was considered simple and suitable for determination of cis-permethrin in hair lotion.