Hyperhidrosis Study Group

PubMed2005

Low-dose efficacy of botulinum toxin A for axillary hyperhidrosis: a randomized, side-by-side, open-label study.

OBJECTIVE: To compare 2 doses of botulinum toxin A in view of dose-dependent efficacy, longevity, and safety. DESIGN: Side-by-side, controlled, randomized clinical trial with extended follow-up over 2 treatment cycles. Patients were injected with 200 U of botulinum toxin A (Dysport; Ipsen Ltd, Wrexham, England) into one axilla and 100 U into the other axilla in a randomized fashion. After 48 weeks of follow-up, the patients were given a second treatment with identical doses to the respective axillae and were again followed up for 48 weeks. Gravimetric measurements of sweat production and the patients' own rating of sweating were monitored. SETTING: University-based outpatient clinic. PATIENTS: Forty-three subjects with primary axillary hyperhidrosis that was unresponsive to topical therapy. MAIN OUTCOME MEASURE: Absolute values of sweat production. RESULTS: Two weeks after treatment, the sweat production was significantly reduced compared with baseline levels. Both doses were equally effective. At week 48, the sweat production had returned to baseline levels irrespective of the dose. After the second treatment, both doses were again equally effective at any follow-up point. At the end of the follow-up period (96 weeks) for the second treatment, the sweat production was significantly lower than at the end of the first follow-up period (48 weeks). The treatment was well tolerated, and there were no lasting or severe adverse effects. CONCLUSIONS: Short- and long-term results show that doses of 100 and 200 U of botulinum toxin A are equally safe and effective. However, because of cost considerations and possible adverse effects, the lower dose is preferable for treating axillary hyperhidrosis.

Adult↗

PubMed2001

Botulinum toxin A for axillary hyperhidrosis (excessive sweating).

BACKGROUND: Treatment of primary focal hyperhidrosis is often unsatisfactory. Botulinum toxin A can stop excessive sweating by blocking the release of acetylcholine, which mediates sympathetic neurotransmission in the sweat glands. METHODS: We conducted a multicenter trial of botulinum toxin A in 145 patients with axillary hyperhidrosis. The patients had rates of sweat production greater than 50 mg per minute and had had primary axillary hyperhidrosis that was unresponsive to topical therapy with aluminum chloride for more than one year. In each patient, botulinum toxin A (200 U) was injected into one axilla, and placebo was injected into the other in a randomized, double-blind manner. (The units of the botulinum toxin A preparation used in this study are not identical to those of other preparations.) Two weeks later, after the treatments were revealed, the axilla that had received placebo was injected with 100 U of botulinum toxin A. Changes in the rates of sweat production were measured by gravimetry. RESULTS: At base line, the mean (+/-SD) rate of sweat production was 192+/-136 mg per minute. Two weeks after the first injections the mean rate of sweat production in the axilla that received botulinum toxin A was 24+/-27 mg per minute, as compared with 144+/-113 mg per minute in the axilla that received placebo (P< 0.001). Injection of 100 U into the axilla that had been treated with placebo reduced the mean rate of sweat production in that axilla to 32+/-39 mg per minute (P<0.001). Twenty-four weeks after the injection of 100 U, the rates of sweat production (in the 136 patients in whom the rates were measured at that time) were still lower than base-line values, at 67+/-66 mg per minute in the axilla that received 200 U and 65+/-64 mg per minute in the axilla that received placebo and 100 U of the toxin. Treatment was well tolerated; 98 percent of the patients said they would recommend this therapy to others. CONCLUSIONS: Intradermal injection of botulinum toxin A is an effective and safe therapy for severe axillary hyperhidrosis.

Adult↗