Treatment of Notalgia Paresthetica With Xeomin

NCT01098019 | Completed Phase 3

• 1 other identifier: Inno-6014
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Notalgia Paresthetica

Keywords

Notalgia paresthetica; Xeomin; Botulinum Toxin A; Pruritus; Upper Back; Hyperpigmentation

Outcome Measures

Primary Outcomes (1)

• Mean % difference in pruritus visual analog score (VAS).

  Changes from baseline in pruritus visual analogue score at Week 8 for patients randomized to Xeomin as compared to placebo

  8 Weeks

Secondary Outcomes (6)

• Mean % difference in area of hyperpigmentation

  12 weeks

• Mean % difference in area of hyperpigmentation

  24 weeks

• Mean number of days before re-appearance of pruritus

  24 weeks

• Mean global efficacy evaluated by investigator

  12 weeks

• Mean global efficacy evaluated by patient

  12 weeks

Study Arms (2)

Xeomin

EXPERIMENTAL

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).

Drug: Xeomin

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo / Xeomin

Interventions

Xeomin DRUG

Patients will receive Xeomin only at Day 0.

Also known as: Botulinum Toxin A

Xeomin

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.

Also known as: Sodium Chloride, Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Innovaderm Research Inc.: lead
• Merz Pharmaceuticals GmbH: collaborator

Study Sites (1)

Innovaderm Research Inc

Montreal, Quebec, H2K 4L5, Canada

Location

MeSH Terms

Conditions

Pruritus; Hyperpigmentation

Interventions

incobotulinumtoxinA; Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pigmentation Disorders

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Catherine Maari, MD, FRCPC

  Innovaderm Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 2, 2010
• Study Start: April 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 23, 2012

Record last verified: 2012-04

Locations

CA (1)