Jornal Vascular Brasileiro
https://app.periodikos.com.br/journal/jvb/article/doi/10.1590/1677-5449.20250065
Jornal Vascular Brasileiro
Original Article

Topical oxybutynin antiperspirant for axillary hyperhidrosis: a phase IIb PROBE design clinical trial (TODAY trial)

Antitranspirante tópico de oxibutinina para hiperidrose axilar: um ensaio clínico de fase IIb com desenho PROBE (estudo TODAY)

Samantha Neves; Elisete Isabel Crocco; Viviane Santana da Silva; Felipe Menegueti; Alexia Paganotti; Ricardo Sanchez Boix; Nelson Wolosker; Roberto Augusto Caffaro

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Abstract

Background: Primary hyperhidrosis is a chronic condition with limited therapeutic options.

Objectives: To evaluate the impact of 10% oxybutynin spray on axillary hyperhidrosis, considering both its local and systemic effects, in terms of Hyperhidrosis Disease Severity Scale (HDSS) outcomes for hyperhidrosis of the axilla and eight additional sites.

Methods: Prospective phase II PROBE design trial. Adult patients with axillary hyperhidrosis were randomized to receive a 10% oxybutynin topical spray, oral oxybutynin, or placebo spray for 35 days. Efficacy was evaluated on day 35 using the HDSS and a hyperhidrosis-specific quality-of-life (QoL) assessment questionnaire.

Results: 17 patients were randomized. No significant differences were observed in HDSS outcomes from baseline to day 35 in any of the three groups (2.5 [2 - 4], 4 [3 - 4], 3.5 [3 - 4], p= 0.207), although a trend to improvement was noted in both treatment groups. Significant improvement in the QoL questionnaire was observed from baseline to day 35 in the oxybutynin spray group (pre-intervention QoL: 78.5 [70 - 96] and post-intervention QoL: 38.5 [32 - 67], p = 0.031).

Conclusions: No differences were observed in the primary outcome. A significant improvement from baseline to day 35 was observed in the QoL questionnaire score for the oxybutynin spray group.

Keywords

dermatology; axillary hyperhidrosis; antiperspirant; oxybutynin

Resumo

Contexto: A hiperidrose primária é uma condição crônica com opções terapêuticas limitadas.

Objetivos: Avaliar o impacto do spray de oxibutinina a 10% na hiperidrose axilar, considerando seus efeitos local e sistêmico, em termos de desfechos da Escala de Gravidade da Doença de Hiperidrose (HDSS) para hiperidrose da axila e oito locais anatômicos adicionais.

Métodos: Estudo prospectivo de fase II com desenho PROBE. Pacientes adultos com hiperidrose axilar foram randomizados para receber spray tópico de oxibutinina a 10%, oxibutinina oral ou spray placebo por 35 dias. A eficácia foi avaliada no dia 35 pela HDSS e por um questionário de avaliação da qualidade de vida (QV) específico para hiperidrose.

Resultados: 17 pacientes foram randomizados. Não foram observadas diferenças significativas nos resultados da HDSS desde o início até o dia 35 em qualquer um dos três grupos (2,5 [2 - 4], 4 [3 - 4], 3,5 [3 - 4], p=0,207), embora tenha sido observada tendência de melhora nos grupos tratados. Foi observada melhora significativa no questionário de QV do início até o dia 35 no grupo do spray de oxibutinina (QV pré-intervenção 78,5 [70 - 96] e QV pós-intervenção 38,5 [32 - 67], p = 0,031).

Conclusões: Não foram observadas diferenças no desfecho primário. Foi observada melhora significativa no questionário de QV do início até o dia 35 no grupo do spray de oxibutinina.

Palavras-chave

dermatologia; hiperidrose axilar; antiperspirante; oxibutinina

References

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Submitted date:
09/04/2025

Accepted date:
05/26/2026

Sociedade Brasileira de Angiologia e Cirurgia Vascular (SBACV)"> Sociedade Brasileira de Angiologia e Cirurgia Vascular (SBACV)">
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