Back to resultsItch Relieving Effect of Botox: a Study in Healthy Subjects
Primary Purpose
Pruritus
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Botox
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Pruritus focused on measuring Itch, Botox, 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Botox
Saline
Arm Description
10 units of Botox intradermally injected into one forearm. The subject is blinded to which forearm receives the Botox and which forearm receives the saline vehicle.
Saline vehicle intradermally injected into the other forearm. The subject is blinded to which forearm receives the Botox and which forearm receives the saline vehicle.
Outcomes
Primary Outcome Measures
Itch by VAS Itch Intensity at Baseline (Visit 1)
The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.
Itch by VAS Itch Intensity at 1 Week (Visit 2)
The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.
Itch by VAS Itch Intensity at 1 Month (Visit 3)
The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.
Itch by VAS Itch Intensity at 3 Months (Visit 4)
The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.
Secondary Outcome Measures
Change in Heat Pain Relief by VAS Pain Intensity Reporting After 1 Week, 1 Month, and 3 Months After Treatment
A secondary endpoint is to see if Botox has a relieving effect on heat pain using a pain visual analog scale (VAS) intensity scale as an outcome measure. The pain VAS intensity scale ranges from a minimum of 0 (no pain - best) to a maximum of 10 (maximum pain - worst). Participants will rate pain intensity after pain is induced with a heat thermode.
Full Information
NCT ID
NCT02639052
First Posted
December 18, 2015
Last Updated
March 16, 2017
Sponsor
Temple University
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT02639052
Brief Title
Itch Relieving Effect of Botox: a Study in Healthy Subjects
Official Title
Itch Relieving Effect of Botox: a Study in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
Several studies have shown that botulinum toxin type A (BoNT/A) has an antipruritic effect due to the inhibition of acetylcholine and other pruritic factors, such as substance P and glutamate. For instance, subcutaneous BoNT/A improves itch accompanied to hand eczema, dermatitis, lichen simplex, and rhinitis. Furthermore, a double-blind, placebo-controlled study showed that BoNT/A reduced histamine itch intensity in healthy men. Since acetylcholine has been shown to mediate itch in atopic dermatitis, this study aims to test the itch relieving effect of BoNT/A on a non-histaminergic model for chronic itch. This non-histaminergic model using the plant cowhage induces itch by activating protease activated receptor 2 (PAR2) receptors, which play a role in the itch of atopic dermatitis, also making this model better suited to test the efficacy of BoNT/A to relive chronic itch.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus
Keywords
Itch, Botox, Healthy Volunteers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Botox
Arm Type
Experimental
Arm Description
10 units of Botox intradermally injected into one forearm. The subject is blinded to which forearm receives the Botox and which forearm receives the saline vehicle.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Saline vehicle intradermally injected into the other forearm. The subject is blinded to which forearm receives the Botox and which forearm receives the saline vehicle.
Intervention Type
Drug
Intervention Name(s)
Botox
Intervention Description
10 units of Botox will be intradermally injected into one 4x4cm area on the volar forearm on 1st study visit.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
10 units of the Saline vehicle will be intradermally injected into one 4x4cm area on the contralateral volar forearm on the 1st study visit.
Primary Outcome Measure Information:
Title
Itch by VAS Itch Intensity at Baseline (Visit 1)
Description
The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.
Time Frame
Baseline (Visit 1)
Title
Itch by VAS Itch Intensity at 1 Week (Visit 2)
Description
The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.
Time Frame
1 week from Baseline
Title
Itch by VAS Itch Intensity at 1 Month (Visit 3)
Description
The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.
Time Frame
1 Month from Baseline
Title
Itch by VAS Itch Intensity at 3 Months (Visit 4)
Description
The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.
Time Frame
3 Months from Baseline
Secondary Outcome Measure Information:
Title
Change in Heat Pain Relief by VAS Pain Intensity Reporting After 1 Week, 1 Month, and 3 Months After Treatment
Description
A secondary endpoint is to see if Botox has a relieving effect on heat pain using a pain visual analog scale (VAS) intensity scale as an outcome measure. The pain VAS intensity scale ranges from a minimum of 0 (no pain - best) to a maximum of 10 (maximum pain - worst). Participants will rate pain intensity after pain is induced with a heat thermode.
Time Frame
Baseline, 1 week, 1 month, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gil Yosipovitch, MD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Itch Relieving Effect of Botox: a Study in Healthy Subjects
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