NCT01671800 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Baumann L, Slezinger A, Halem M, Vujevich J, Mallin K, Charles C, Martin LK, Black L, Bryde J
Double-blind, randomized, placebo-controlled pilot study of the safety and efficacy of Myobloc (botulinum toxin type B) for the treatment of palmar hyperhidrosis. Dermatol Surg. 2005 Mar;31(3):263-70.
Baumann LS, Halem ML
Botulinum toxin-B and the management of hyperhidrosis. Clin Dermatol. 2004 Jan-Feb;22(1):60-5. Review.
Flynn TC, Clark RE 2nd
Botulinum toxin type B (MYOBLOC) versus botulinum toxin type A (BOTOX) frontalis study: rate of onset and radius of diffusion. Dermatol Surg. 2003 May;29(5):519-22; discussion 522.
Hund M, Kinkelin I, Naumann M, Hamm H
Definition of axillary hyperhidrosis by gravimetric assessment. Arch Dermatol. 2002 Apr;138(4):539-41.
Kern U, Kohl M, Seifert U, Schlereth T
Botulinum toxin type B in the treatment of residual limb hyperhidrosis for lower limb amputees: a pilot study. Am J Phys Med Rehabil. 2011 Apr;90(4):321-9. doi: 10.1097/PHM.0b013e31820636fd.

Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy of Botulinum Toxin B (Myobloc) for the Treatment of Prosthesis Associated Symptomatic Sweating, or Residual Limb Hyperhidrosis in Amputees

Details for clinical trial NCT01671800

Clinical trial NCT01671800 - References