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Itch Relieving Effect of Botox: a Study in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02639052
Recruitment Status : Completed
First Posted : December 24, 2015
Results First Posted : April 27, 2017
Last Update Posted : April 27, 2017
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Temple University

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.

Condition or disease Intervention/treatment Phase
Pruritus Drug: Botox Drug: Saline Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Itch Relieving Effect of Botox: a Study in Healthy Subjects
Study Start Date : February 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Itching

Arm Intervention/treatment
Experimental: Botox
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.
Drug: Botox
10 units of Botox will be intradermally injected into one 4x4cm area on the volar forearm on 1st study visit.

Placebo Comparator: Saline
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.
Drug: Saline
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 Measures :
  1. Itch by VAS Itch Intensity at Baseline (Visit 1) [ Time Frame: 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.

  2. Itch by VAS Itch Intensity at 1 Week (Visit 2) [ Time Frame: 1 week from Baseline ]
    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.

  3. Itch by VAS Itch Intensity at 1 Month (Visit 3) [ Time Frame: 1 Month from Baseline ]
    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.

  4. Itch by VAS Itch Intensity at 3 Months (Visit 4) [ Time Frame: 3 Months from Baseline ]
    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 :
  1. Change in Heat Pain Relief by VAS Pain Intensity Reporting After 1 Week, 1 Month, and 3 Months After Treatment [ Time Frame: Baseline, 1 week, 1 month, 3 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy volunteers between 18 and 50 years of age.
  2. Must be in general good health with no disease or physical conditions that would impair evaluation of itch and pain perception.
  3. No history of chronic itch or pain.
  4. 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.
  5. Must abstain from the use of moisturizers on the arm.

Exclusion Criteria:

  1. Individuals under 18 or over 50 years of age.
  2. Inability to complete the required measures.
  3. The presence of an itchy skin disease.
  4. Diagnosis of diseased that would affect itch or pain perception (e.g. neuropathies).
  5. Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
  6. 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.).
  7. Use of emollients on the arms a week prior to the study and throughout the study.
  8. Use of anti-depressants, anti-psychotics, and illicit drugs.
  9. Known history of neuropathy, uremia, uncontrolled thyroid disease, and diabetes mellitus.
  10. Use of Botulinum toxin in the last year.
  11. Known allergies to Botox.
  12. Pregnant women. (Women of child bearing potential will undergo an human chorionic gonadotrophin (hCG) pregnancy test before Botox application).
  13. Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
  14. Infection at the injection site.
  15. Cardiovascular disease.
  16. Neuromuscular disorder (e.g., amyotrophic lateral sclerosis, myasthenia gravis, or Lambert-Eaton syndrome).
  17. Compromised respiratory function.
  18. Dysphagia.
  19. History of urinary tract infection.
  20. History of urinary retention.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639052


Sponsors and Collaborators
Temple University
Allergan
Investigators
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Principal Investigator: Gil Yosipovitch, MD Temple University
Publications:

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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT02639052    
Other Study ID Numbers: 23230
126938 ( Other Identifier: FDA IND )
First Posted: December 24, 2015    Key Record Dates
Results First Posted: April 27, 2017
Last Update Posted: April 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Temple University:
Itch
Botox
Healthy Volunteers
Additional relevant MeSH terms:
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Pruritus
Skin Diseases
Skin Manifestations