Treatment of Notalgia Paresthetica With Xeomin
Notalgia Paresthetica
About this trial
This is an interventional treatment trial for Notalgia Paresthetica focused on measuring Notalgia paresthetica, Xeomin, Botulinum Toxin A, Pruritus, Upper Back, Hyperpigmentation
Eligibility 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:
- Condom with spermicidal foam or jelly, sponge with spermicidal foam or jelly, diaphragm with spermicidal foam or jelly
- Intra uterine device (IUD)
- Contraceptives (oral or parenteral)
- Nuvaring
- Vasectomy or vasectomised partner
- Surgically sterile or post-menopausal partner
- 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
Sites / Locations
- Innovaderm Research Inc
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Xeomin
Placebo
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).
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.