ORLANDO Botulinum toxin type A administered intradermally was safe and effective in reducing the severity of primary axillary hyperhidrosis, in a multicenter trial of adolescents.
The first two treatments produced relief from uncontrolled, excessive sweating, and that relief lasted about 4.5 months each time. The results suggest that teens may need only two or three treatments per year, Dr. Dee Anna Glaser reported in a poster at the annual meeting of the American Society for Dermatologic Surgery.
Treatment for up to 1 year with botulinum toxin type A was well tolerated, and patients reported marked improvements in health-related quality of life and fewer social, physical, and emotional impairments, said Dr. Glaser, professor of dermatology at St. Louis University.
In the 52-week study sponsored by Allergan Inc., 144 patients (aged 1217 years) were injected with 100 U (50 U per axilla) at each treatment session. A maximum of six treatments was allowed, depending on the response to treatment and the duration of the response; patients had to wait at least 8 weeks between treatments.
The primary efficacy end point was the patients' assessment of the severity of their underarm sweating using the 4-point Hyperhidrosis Disease Severity Scale (HDSS), where:
▸ 1 = Never noticeable and never interferes with my daily activities.
▸ 2 = Tolerable but sometimes interferes with my daily activities.
▸ 3 = Barely tolerable and frequently interferes with my daily activities.
▸ 4 = Intolerable and always interferes with my daily activities.
Before the first treatment, patients' HDSS scores ranged from 3 to 4. Four weeks after the second treatment, 62% of patients improved to an HDSS score of 1, Dr. Glaser and her associates wrote.
Sweat production was reduced by at least 50% in at least 93% of patients after the first treatment, by 75% or more in at least 79% of patients after the second treatment, and by more than 90% in at least 52% of patients after the third treatment, the investigators found.
Health outcomes were assessed at each office visit using the Children's Dermatology Life Quality Index and the Children's Hyperhidrosis Impact Questionnaire. These questionnaires measure the impact of hyperhidrosis on children's quality of life, ask about symptoms, and assess feelings regarding the impact on leisure time, school or holidays, personal relationships, sleep, and treatment.
Dr. Glaser and her associates reported that botulinum toxin type A treatment significantly improved all of these domains, with the exception of sleep.
Most adverse events with treatment were mild or moderate in severity, and none led to discontinuation. Most were related to the injection and included pain, pyrexia, bruising, erythema, irritation, and swelling. These occurred in less than 3% of patients.
Dr. Glaser disclosed that she is a consultant for Allergan.
Sweat production was reduced by at least 50% in 93% of patients after their first treatment. DR. GLASER