Treatment of Notalgia Paresthetica With Xeomin

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovaderm Research Inc.
• Collaborator: Merz Pharmaceuticals GmbH
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Men or women between 18 and 75 years of age at the time of consent

• Presence of notalgia paresthetica, resistant to topical therapy, for at least one year and stable for the past 3 months prior to Day 0.

• Unless surgically sterile (or at least 1 year post-menopausal for women), or abstinent, patient (male or female) is willing to use an effective method of contraception for at least 30 days before Day 0 and until at least 12 months after the last drug administration. Effective method of contraception include:

1. Condom with spermicidal foam or jelly, sponge with spermicidal foam or jelly, diaphragm with spermicidal foam or jelly

2. Intra uterine device (IUD)

3. Contraceptives (oral or parenteral)

4. Nuvaring

5. Vasectomy or vasectomised partner

6. Surgically sterile or post-menopausal partner

7. Same-sex partner

• Capable of giving informed consent; the consent must be obtained prior to any study related procedures.

• Negative urine pregnancy test (female of childbearing potential only)

Exclusion Criteria:

• Current Pregnancy of lactation

• Very mild notalgia paresthetica as defined by the absence of a clear zone of hyperpigmentation on the affected area on the back Severe notalgia paresthetica as defined by presence of excoriations, erosions or significant scarring in affected area on the back

• Use of any topical treatment on the affected area within 14 days of Day 0

• Use of botulinum toxin A within the past 12 weeks of Day 0

• Previous use of botulinum toxin A in the affected area on the back

• Use of systemic medication that can have an influence on pruritus such as antihistamines within 14 days of Day 0

• Use of systemic corticosteroids within 28 days of Day 0

• Hypersensitivity to Xeomin

• Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert Eaton syndrome)

• Presence of infection on the affected area on the back