Clinical evaluation of paraprobiotic‐associatedBifidobacterium lactisCCT 7858 anti‐dandruff shampoo efficacy: A randomized placebo‐controlled clinical trial

Author:

de Jesus Gabriel Fernandes Alves12,Rossetto Marina Piola12,Voytena Ana2,Feder Bianca1,Borges Heloisa3,da Costa Borges Gabriel4,Feuser Zoé Paulina3,Dal‐Bó Silvia3,Michels Monique1ORCID

Affiliation:

1. BioHall Consultoria, Pesquisa e Inovação Itajai Santa Catarina Brazil

2. Gabbia Biotechnology Itajai Santa Catarina Brazil

3. Undergraduate Pharmacy Course University of Southern Santa Catarina (UNESC) Criciuma Brazil

4. Laboratory of Experimental Pathophysiology, Graduate Program in Health Sciences University of Southern Santa Catarina (UNESC) Criciuma Brazil

Abstract

AbstractObjectiveThe 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.MethodsRandomized, 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.ResultsNo 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.DiscussionTopical 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.

Funder

Universidade do Extremo Sul Catarinense

Publisher

Wiley

Subject

Colloid and Surface Chemistry,Dermatology,Drug Discovery,Pharmaceutical Science,Aging,Chemistry (miscellaneous)

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