BOTOX ® Cosmetic (botulinum toxin type A) is FDA approved for the treatment of severe primary axillary hyperhidrosis (underarm sweating). A debilitating medical condition, excessive underarm, hand and foot sweating affects an over 7 million Americans.
As this condition affects millions of people and many people who suffer from primary underarm sweating do not realize they have a chronic, but treatable, medical condition, and that many physicians are not fully aware of how to diagnosis and treat hyperhidrosis.
In the Phase III clinical study that involved 322 patients, more than 80 percent treated with BOTOX ® Cosmetic experienced a greater than 50 percent decrease in underarm sweat production. The treatment, administered by injection, lasted an average of 6.5 months.
When current topical treatments do not produce the desired results, BOTOX ® Cosmetic may provide many patients living with severe primary axillary hyperhidrosis with an effective alternative. BOTOX ® Cosmetic is contraindicated in the presence of infection at the proposed injection site and in individuals with known hypersensitivity to any ingredient in the formulation. Serious or immediate hypersensitive reactions have been rarely reported. These reactions included anaphylaxis, urticaria, soft tissue edema, and dyspnea. If such a reaction occurs, further injection of BOTOX ® Cosmetic should be discontinued and appropriate medical therapy should be immediately instituted.
Hyperhidrosis can be measured using the Hyperhidrosis Disease Severity Scale (HDSS),
a four-point scale designed to assess the severity of primary axillary hyperhidrosis in everyday clinical practice or in clinical research. The HDSS can be administered by an interview of self-completed by the patient. Patients rate the severity as:
- 1= "Underarm sweating never noticeable/never interferes with daily activities",
- 2= "Underarm sweating tolerable/sometimes interferes with my daily activities",
- 3= "Underarm sweating barely tolerable/frequency interferes with my daily activities",
- 4= "Underarm sweating intolerable/always interferes with my daily activities".
About BOTOX ® Cosmetic
BOTOX ® Cosmetic is a sterile, purified protein that works by blocking the nerve impulses that, in the case of severe primary axillary hyperhidrosis ineffectively managed with topical agents marks the fourth therapeutic indication for BOTOX ® Cosmetic in the U.S. Worldwide, BOTOX ® Cosmetic is currently one of the most widely researched medicines with approximately 20 approved indication in more than 70 countries.