Phase 2
N=35
Itch Relieving Effect of Botox: a Study in Healthy Subjects
Pruritus
Bottom Line
View on ClinicalTrials.gov: NCT02639052 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Itch by VAS Itch Intensity at Baseline (Visit 1) — 4.5; 4.3; 6.5; 6.3 units on a scale — p=0.9704
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Botox (Drug); Saline (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Temple University
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Itch by VAS Itch Intensity at Baseline (Visit 1) |
4.5; 4.3; 6.5; 6.3; 6.8; 6.5 | 0.9704 |
| PRIMARY Itch by VAS Itch Intensity at 1 Week (Visit 2) |
3.3; 4.0; 5.4; 6.7; 5.9; 6.9 | <0.0001 sig |
| PRIMARY Itch by VAS Itch Intensity at 1 Month (Visit 3) |
3.2; 3.8; 5.0; 6.2; 5.1; 6.2 | <0.0001 sig |
| PRIMARY Itch by VAS Itch Intensity at 3 Months (Visit 4) |
2.3; 3.3; 4.5; 5.4; 4.9; 5.9 | 0.0004 sig |
| SECONDARY Change in Heat Pain Relief by VAS Pain Intensity Reporting After 1 Week, 1 Month, and 3 Months After Treatment |
3.6; 3.7; 3.7; 3.7; 3.7; 4.1 | 0.1306 |
Summary
The purpose of this study is to determine if Botox is effective in the treatment of an experimentally induced itch that mimics chronic itch in healthy volunteers.
Eligibility Criteria
Inclusion Criteria
- Healthy volunteers between 18 and 50 years of age.
- Must be in general good health with no disease or physical conditions that would impair evaluation of itch and pain perception.
- No history of chronic itch or pain.
- Must abstain from the use of any systemic or topical anti-histamine, steroid, or pain relief medications from the week prior to the study till the completion of the study.
- Must abstain from the use of moisturizers on the arm.
Exclusion Criteria
- Individuals under 18 or over 50 years of age.
- Inability to complete the required measures.
- The presence of an itchy skin disease.
- Diagnosis of diseased that would affect itch or pain perception (e.g. neuropathies).
- Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
- Use of oral, topical analgesics, or other medications known to interfere with itch or pain perception in the week prior to the study and throughout the study (e.g. antihistamines, anesthetics, opioids, neuroleptics, etc.).
- Use of emollients on the arms a week prior to the study and throughout the study.
- Use of anti-depressants, anti-psychotics, and illicit drugs.
- Known history of neuropathy, uremia, uncontrolled thyroid disease, and diabetes mellitus.
- Use of Botulinum toxin in the last year.
- Known allergies to Botox.
- Pregnant women. (Women of child bearing potential will undergo an human chorionic gonadotrophin (hCG) pregnancy test before Botox application).
- Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
- Infection at the injection site.
- Cardiovascular disease.
- Neuromuscular disorder (e.g., amyotrophic lateral sclerosis, myasthenia gravis, or Lambert-Eaton syndrome).
- Compromised respiratory function.
- Dysphagia.
- History of urinary tract infection.
- History of urinary retention.
Data sourced from ClinicalTrials.gov (NCT02639052). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.