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Clinical Pharmacology
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Clinical Pharmacology

Botox

Splenius capitis/cervicis

83

38

25-50

Sternocleidomastoid

77

25

17-31

Levator scapulae

52

20

16-25

Trapezius

49

29

18-33

Semispinalis

16

21

13-25

Scalene

15

15

6-21

Longissimus

8

29

17-41

*The mid-range of dose is calculated as the 25th to 75th percentiles.

NOTE: There were 16 patients who had additional muscles injected.

Primary Axillary Hyperhidrosis: The efficacy and safety of BOTOX® for the treatment of primary axillary hyperhidrosis were evaluated in two randomized, multi-center, double-blind, placebo-controlled studies.

Study 1 included adult patients with persistent primary axillary hyperhidrosis who scored 3 or 4 on a Hyperhidrosis Disease Severity Scale (HDSS) and who produced at least 50mg of sweat in each axilla at rest over 5 minutes. HDSS is a 4-point scale with 1= "underarm sweating is never noticeable and never interferes with my daily activities"; to 4 = "underarm sweating is intolerable and always interferes with my daily activities". Atotal of 322 patients were randomized in a 1:1:1 ratio to treatment in both axillae with either 50 Units of BOTOX®, 75 Units of BOTOX®, or placebo. Patients were evaluated at 4-week intervals. Patients who responded to the first injection were re-injected when they reported a re-increase in HDSS score to 3 or 4 and produced at least 50mg sweat in each axilla by gravimetric measurement, but no sooner than 8 weeks after the initial injection.

Study responders were defined as patients who showed at least a 2-grade improvement from baseline value on the HDSS 4 weeks after both of the first two treatment sessions or had a sustained response after their first treatment session and did not receive re-treatment during the study. Spontaneous resting axillary sweat production was assessed by weighing a filter paper held in the axilla over a period of 5 minutes (gravimetric measurement). Sweat production responders were those patients who demonstrated a reduction in axillary sweating from baseline of at least 50% at week 4.

In the three study groups the percentage of patients with baseline HDSS score of 3 ranged from 50% to 54% and from 46 % to 50% for a score of 4. The median amount of sweat production (averaged for each axilla) was 102 mg, 123 mg, and 114 mg for the placebo, 50 Units and 75 Units groups respectively.

The percentage of responders based on at least a 2-grade decrease from baseline in HDSS or based on a >50% decrease from baseline in axillary sweat production was greater in both BOTOX® groups than in the placebo group (p < 0.001), but was not significantly different between the 2 BOTOX® doses (See Table 3).

Table 3: Study 1. Study Outcomes

Treatment Response

BOTOX® 50 Units N = 104

BOTOX® 75 Units N=110

Placebo N= 108

BOTOX® 50- Placebo (95% CI)

BOTOX® 75-placebo (95% CI)

HDSS Score change

³2 % (n)a

55% (57)

49% (54)

6% (6)

49.3%

(38.8, 59.7)

43%

(33.2, 53.8)

>50% decrease in axillary sweat production % (n)

81% (84)

86% (94)

41% (44)

40%

(28.1, 52.0)

45%

(33.3, 56.1)
Brand Name: Botox
Generic Name: Botulinum Toxin Type A
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