Naumann M., Lowe N.J., Kumar C.R. et al. Botulinum toxin type a is a safe and effective treatment for axillary hyperhidrosis over 16 months: a prospective study. Arch. Dermatol. 2003; 139: 731-6.
Objective: To evaluate the safety and efficacy of botulinum toxin type A (BTX-A) (Botox) over 16 months in the treatment of bilateral primary axillary hyperhidrosis.
Design: a 16-month study with initial double-blind randomization to 50 U of BTX-A or placebo per axilla. After 4 months, participants could receive up to 3 further treatments with open-label BTX-A over 12 months.
Setting: fourteen dermatology or neurology clinics in Germany, Belgium, and the United Kingdom.
Participants: of 207 individuals aged between 17 and 74 years who had persistent bilateral primary axillary hyperhidrosis that interfered with daily activities, 174 (84 %) completed the study. The baseline gravimetric assessment was a spontaneous sweat production of 50 mg or greater in each axilla prior to initial treatment.
Main Outcome Measures: at week 4 after each treatment, the response rate of subjects who had at least a 50 % reduction from baseline in axillary sweating, as measured by gravimetric assessment, was evaluated. Adverse events were spontaneously reported throughout the study, together with quality-of-life parameters and assessment of neutralizing antibodies to BTX-A.
Results: over the 16-month period, 356 BTX-A treatments were given to 207 subjects. After placebo treatment, the response rate at week 4 was 34.7 %. After the first, second, and third treatment with BTX-A, response rates at week 4 were 96.1 %, 91.1 %, and 83.3 %, respectively. For subjects receiving more than 1 treatment, the mean duration between BTX-A treatments was approximately 7 months; however, 28 % of subjects completed the study after only 1 BTX-A treatment. Subjects' satisfaction after treatments was consistently high, their quality of life improved, and there was a reduction in the impact of the disease on their lives. The safety profile of BTX-A after repeated treatments was excellent and no confirmed positive results for neutralizing antibodies to BTX-A occurred.
Conclusion: repeated intradermal injections of BTX-A over 16 months for treatment of primary axillary hyperhidrosis is safe and efficacious.
2. Lowe P.L., Cerdan-Sanz S., Lowe N.J. Botulinum toxin type A in the treatment of bilateral primary axillary hyperhidrosis: efficacy and duration with repeated treatments. Dermatol Surg 2003; 29: 545-8.
3. Heckmann M., Teichmann B., Pause B.M. et al. Amelioration of body odor after intracutaneous axillary injection of botulinum toxin A. Arch Dermatol 2003; 139: 57-9.
4. Belin E.E., Polo J. Treatment of compensatory hyperhidrosis with botulinum toxin type A. Cutis 2003; 71: 68-70.
5. Kreyden O.P., Böni R., Burg G. Hyperhidrosis and botulinum toxin in dermatology, Vol. 30. Zurich: Karger, 2002.
6. Heckmann M. Hyperhidrosis of the axilla. Curr Probl Dermatol 2002; 30: 149-55.
7. Heckmann M., Schaller M., Breit S. et al. Evaluation of therapeutic success of hyperhidrosis therapy. Arch Dermatol 2001; 137: 94.
8. Heckmann M., Ceballos-Baumann A.O., Plewig G. Botulinum toxin A for axillary hyperhidrosis (excessive sweating). N Engl J Med 2001; 344: 488-93.
1 post • Page 1 of 1
Who is online
Users browsing this forum: No registered users and 2 guests