Itch Relieving Effect of Botox: a Study in Healthy Subjects

NCT02639052 | Completed Phase 1 Results

• 2 other identifiers: 23230126938
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pruritus

Keywords

Itch; Botox; Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline (Visit 1)

• 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.

  1 week from Baseline

• 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.

  1 Month from Baseline

• 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.

  3 Months from Baseline

Secondary Outcomes (1)

• Change in Heat Pain Relief by VAS Pain Intensity Reporting After 1 Week, 1 Month, and 3 Months After Treatment

  Baseline, 1 week, 1 month, 3 months

Study Arms (2)

Botox

EXPERIMENTAL

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

Saline

PLACEBO COMPARATOR

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

Interventions

Botox DRUG

10 units of Botox will be intradermally injected into one 4x4cm area on the volar forearm on 1st study visit.

Botox

Saline DRUG

10 units of the Saline vehicle will be intradermally injected into one 4x4cm area on the contralateral volar forearm on the 1st study visit.

Saline

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Temple University: lead
• Allergan: collaborator

Related Publications (13)

• Huang W, Foster JA, Rogachefsky AS. Pharmacology of botulinum toxin. J Am Acad Dermatol. 2000 Aug;43(2 Pt 1):249-59. doi: 10.1067/mjd.2000.105567.

  PMID: 10906647 BACKGROUND

• Hallett M. How does botulinum toxin work? Ann Neurol. 2000 Jul;48(1):7-8. No abstract available.

  PMID: 10894209 BACKGROUND

• Ishikawa H, Mitsui Y, Yoshitomi T, Mashimo K, Aoki S, Mukuno K, Shimizu K. Presynaptic effects of botulinum toxin type A on the neuronally evoked response of albino and pigmented rabbit iris sphincter and dilator muscles. Jpn J Ophthalmol. 2000 Mar-Apr;44(2):106-9. doi: 10.1016/s0021-5155(99)00197-5.

  PMID: 10715374 BACKGROUND

• Cui M, Khanijou S, Rubino J, Aoki KR. Subcutaneous administration of botulinum toxin A reduces formalin-induced pain. Pain. 2004 Jan;107(1-2):125-33. doi: 10.1016/j.pain.2003.10.008.

  PMID: 14715398 BACKGROUND

• Wollina U, Karamfilov T. Adjuvant botulinum toxin A in dyshidrotic hand eczema: a controlled prospective pilot study with left-right comparison. J Eur Acad Dermatol Venereol. 2002 Jan;16(1):40-2. doi: 10.1046/j.1468-3083.2002.00361.x.

  PMID: 11952288 BACKGROUND

• Swartling C, Naver H, Lindberg M, Anveden I. Treatment of dyshidrotic hand dermatitis with intradermal botulinum toxin. J Am Acad Dermatol. 2002 Nov;47(5):667-71. doi: 10.1067/mjd.2002.124605.

  PMID: 12399757 BACKGROUND

• Heckmann M, Heyer G, Brunner B, Plewig G. Botulinum toxin type A injection in the treatment of lichen simplex: an open pilot study. J Am Acad Dermatol. 2002 Apr;46(4):617-9. doi: 10.1067/mjd.2002.120455.

  PMID: 11907521 BACKGROUND

• Unal M, Sevim S, Dogu O, Vayisoglu Y, Kanik A. Effect of botulinum toxin type A on nasal symptoms in patients with allergic rhinitis: a double-blind, placebo-controlled clinical trial. Acta Otolaryngol. 2003 Dec;123(9):1060-3. doi: 10.1080/00016480310000755.

  PMID: 14710908 BACKGROUND

• Gazerani P, Pedersen NS, Drewes AM, Arendt-Nielsen L. Botulinum toxin type A reduces histamine-induced itch and vasomotor responses in human skin. Br J Dermatol. 2009 Oct;161(4):737-45. doi: 10.1111/j.1365-2133.2009.09305.x. Epub 2009 May 11.

  PMID: 19624547 BACKGROUND

• Heyer G, Vogelgsang M, Hornstein OP. Acetylcholine is an inducer of itching in patients with atopic eczema. J Dermatol. 1997 Oct;24(10):621-5. doi: 10.1111/j.1346-8138.1997.tb02305.x.

  PMID: 9375459 BACKGROUND

• Wessler I, Reinheimer T, Kilbinger H, Bittinger F, Kirkpatrick CJ, Saloga J, Knop J. Increased acetylcholine levels in skin biopsies of patients with atopic dermatitis. Life Sci. 2003 Mar 28;72(18-19):2169-72. doi: 10.1016/s0024-3205(03)00079-1.

  PMID: 12628475 BACKGROUND

• Reddy VB, Iuga AO, Shimada SG, LaMotte RH, Lerner EA. Cowhage-evoked itch is mediated by a novel cysteine protease: a ligand of protease-activated receptors. J Neurosci. 2008 Apr 23;28(17):4331-5. doi: 10.1523/JNEUROSCI.0716-08.2008.

  PMID: 18434511 BACKGROUND

• Papoiu AD, Tey HL, Coghill RC, Wang H, Yosipovitch G. Cowhage-induced itch as an experimental model for pruritus. A comparative study with histamine-induced itch. PLoS One. 2011 Mar 14;6(3):e17786. doi: 10.1371/journal.pone.0017786.

  PMID: 21423808 BACKGROUND

MeSH Terms

Conditions

Pruritus

Interventions

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

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

Results Point of Contact

• Title: Susan G. Fisher, M.S., Ph.D., Associate Dean and Director, Temple Clinical Research Institute
• Organization: Lewis Katz School of Medicine at Temple University

susan.fisher@tuhs.temple.edu

215-707-3577

Study Officials

• Gil Yosipovitch, MD

  Temple University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 24, 2015
• Study Start: February 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: January 1, 2017
• Last Updated: April 27, 2017
• Results First Posted: April 27, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share