Treatment of Notalgia Paresthetica With Xeomin

Conditions

• Notalgia Paresthetica

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Xeomin — DRUG
  Patients will receive Xeomin only at Day 0.
• Placebo / Xeomin — DRUG
  Patients will receive 0.9% mL NaCl alone at Day 0. After unblinding (at week 12) patients who were randomized to placebo will receive Xeomin.

Study Details

Patients will be randomized (1:1) to receive either injections of Xeomin in 0.9% NaCl or NaCl alone. Xeomin will be reconstituted with 2 mL of NaCl 0.9 which will give a final concentration of 5 U of botulinum toxin A per 0.1 mL. The area affected will be injected with 0.1 mL at each 1-2 cm2 for a maximum total dose of 200 units. Patients will be evaluated at Weeks 8, 12, 18 and 24. An unblinded pharmacist or designee will prepare placebo and Xeomin injections. Patients will be unblinded at the end of the week 12 visit. After unblinding (at week 12) patients who were randomized to placebo will receive Xeomin while patients initially randomized to Xeomin will not be injected. All patients will be seen for follow-up visits at Weeks 18 and 24. Efficacy in reducing pruritus will be measured with a 10 cm visual analogue score. This will be performed at Day 0, Week 8, Week 12, Week 18 and Week 24. Efficacy will also be measured by measuring the area of the hyperpigmented zone on the back. Safety will be evaluated with adverse events.

Key Dates

Start date

Apr 30, 2010

Status verified

Apr 2012

Primary completion

Feb 29, 2012

Completion

Feb 29, 2012

Study Design

Enrollment

20 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Xeomin
  Each bottle of Xeomin will be reconstituted with 2 mL of NaCl 0.9 which will give a final concentration of 5 U of botulinum toxin A per 0.1 mL. The area affected will be injected with 0.1 mL at each 1-2 square cm for a maximum total dose of 200 units (4mL).
• Placebo Comparator: Placebo
  Patients will receive 0.9% mL NaCl alone. The area affected will be injected with 0.1 mL at each 1-2 square cm for a maximum volume of 4 mL.

Primary Outcome Measure

Mean % difference in pruritus visual analog score (VAS). [ Time Frame: 8 Weeks ]