Clinical Evaluation of the Impact of a Skincare Soap on Clinical Signs and Microbiota Modulation in Pediatric Patients Prone to Atopic Dermatitis.

Author: Carla Monserrat Grecco Lopes; Ana Lucia Tabarini Alves Pinheiro; Vivienne Carduz Castilho; Maura Gonzaga Lapa; Janayna de Godoi Rampazo; Vania Renata Gonçalves; Barbara de Freitas Carli; Gustavo Facchini; Samara Eberlin; Juliana Rodrigues Pinto; Paula Bonilha Fernandes.

Published at: January 17, 2025

Libbs Farmacêutica Ltda, São Paulo/SP – Brazil
Kosmoscience Group, Valinhos/SP – Brazil

Conflict of interest
- Ana Lucia Tabarini Alves Pinheiro, Vania Renata Gonçalves, Barbara de Freitas Carli, Gustavo Facchini, Janayna de Godoi Rampazo, Samara Eberlin and Juliana Rodrigues Pinto, are employees at Kosmoscience Group, responsible for carrying out the study.
- Paula Bonilha Fernandes, Vivienne Carduz Castilho and Maura Gonzaga Lapa are employees at Libbs Pharmaceutical, study sponsor.

Objective 1: to assess the safety and effectiveness of a skincare soap in controlling the clinical symptoms of atopic dermatitis, using subjective evaluation techniques.
Objective 2: to investigate the impact of the skincare soap on microbiota modulation by analyzing gene expression of Staphylococcus aureus and Staphylococcus epidermidis in swabs collected during the clinical trial.

Atopic dermatitis (AD) is associated with an overcolonization of Staphylococcus aureus, especially during flares, resulting in dysbiosis and decreased bacterial diversity. This study was based on the hypothesis that home use of skincare soap provides gentle cleansing without harming the skin in children with skin prone to AD. Skincare soap (UmAI) was formulated with a blend of lipids, glycine soy and bisabolol. Over 28 days, pediatric research participants with a diagnosis or history of non-active atopic dermatitis, or a first-degree family history (n=34; 1-11y) were instructed to apply the soap to damp skin on the face and body during each bath (Ethics Committee nº5.392.397). Cutaneous and ophthalmological acceptability was evaluated before (D0) and after 28 days (D28) using UmAI, and no signs of irritation, allergic reactions, or discomfort were related. Perceived effectiveness was answered by the participant or their parents on D28. Results indicated that soap gently cleanses the skin without causing damage or dryness, and 85% of participants reported a sensation of softness and hydration. Microbiota assessment involved quantifying Staphylococcus aureus and Staphylococcus epidermidis in forearm swab samples using Real-Time qPCR on D0 and D28. Compared to D0, UmAI significantly reduced Staphylococcus aureus up to 80% of the panel, and increased Staphylococcus epidermidis up to 60%. In conclusion, these findings support the inclusion of UmAI skincare soap in the daily hygiene routine for children with AD-prone, emphasizing its mild cleansing properties. The effectiveness of UmAI is likely linked to its ability to balance the dysbiosis commonly associated with AD.

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