RT info:eu-repo/semantics/doctoralThesis
T1 Estudio observacional para describir la eficacia, seguridad y calidad de vida con dos dosisdiferentes de toxina botulínica tipo a en hiperhidrosis axilar primaria severa
A1 Antón Andrés, María Jesús
A2 Universidad de Valladolid. Escuela de Doctorado
K1 Toxina botulínica
K1 Hyperhidrosis
K1 Hiperhidrosis
K1 Toxin
K1 Toxina
K1 32 Ciencias Médicas
AB Hyperhidrosis is defined as the production of more sweat than is necessary for its thermoregulatory function, being clinically perceptible, unpredictable and involuntary, negatively affecting the quality of life of patients, interfering with their social, educational, work and family life.	It appears in the early stages of life, affecting both children and adults, with a frequent family history. It is classified according to aetiology as primary or secondary, according to location as focal or generalised, and according to severity as mild, moderate or severe. The diagnosis of primary focal hyperhidrosis is based on anamnesis and clinical findings. Treatment options range from topical treatments to botulinum toxin infiltrations, systemic therapies or surgical interventions, depending on the location and severity.  Three non-interchangeable preparations of botulinum toxin type A are marketed in Spain: onabotulinum, abobotulinum and incobotulinum toxin. In 2004, the FDA approved onabotulinum toxin A (Botox) for severe primary axillary hyperhidrosis.  	There is no consensus on the dose of botulinum toxin to be injected into each axilla. The technical data sheet for Botox indicates a dose of 50 U/axilla, but several studies have used higher doses, with longer duration of anhidrosis, so we considered it interesting to carry out this study to try to provide information on the most appropriate dose to control hyperhidrosis for as long as possible without increasing side effects. 	The aim of the study was to evaluate the efficacy of two different doses of onabotulinum toxinA, 50 U or 100 U in each axilla, in severe primary axillary hyperhidrosis. A descriptive, observational, cross-sectional and post-authorisation study was carried out in patients over 14 years of age referred to the Rehabilitation Service of the Hospital Rio Hortega in Valladolid. Thirty-one patients were included, assigned by simple random sampling to two treatment groups according to the dose administered. A total of 82 procedures were performed during the follow-up period, as some of the patients received more than one infiltration when the effect of the toxin diminished and they started with hypersweating again.	Post-treatment hyperhidrosis severity was assessed using the Hyperhidrosis Disease Severity Scale (HDSS) and the Analog Visual Scale (VAS), and quality of life was assessed using the Dermatology Life Quality Index (DLQI) questionnaire. At the end of the study patients completed the Patient Global Improvement Impression scale (PGI-I).	Mean age of the patients was 33.4+-10.2, with female predominance, and family history in 51.6 % of the patients. The number of procedures performed was similar in both groups, 40 in the 50 U toxin group and 42 in the 100 U group.	Mean baseline HDSS was 3.25±0.44 and 3.19±0.39, respectively, with a decrease of 2 points at 1 month of treatment in both groups, with a decrease of more than 1 point persisting at 9 months in the 50 U group and 0.7 points in the 100 U group, with no significant differences. The mean baseline DLQI scores were 11.5+-5.9 and 9.4+- 3, respectively, indicating moderate-severe impairment of quality of life. One month after infiltration, the mean decrease was more than 10 points in the 50 U group and more than 9 points in the 100 U group.	Botulinum toxin type A infiltration reduced the severity of hyperhidrosis without significant differences between the two groups, with improvement in quality of life and no serious side effects.
YR 2025
FD 2025
LK https://uvadoc.uva.es/handle/10324/75475
UL https://uvadoc.uva.es/handle/10324/75475
LA spa
NO Escuela de Doctorado
DS UVaDOC
RD 03-abr-2025