PruritusPhase 1/2NCT02639052

Itch Relieving Effect of Botox: a Study in Healthy Subjects

A Phase 1/2 study testing Botox and Saline in people with Pruritus, run by Temple University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Pruritus
What is being tested?: Botox and Saline
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 35 participants
Where: No sites listed yet
Study dates: Feb 2016to Jan 2017
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.).

Show all 20Show fewer

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.

About this study

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.

Read the 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.

Conditions: Pruritus
Being tested: Botox, Saline
Keywords: Itch, Botox, Healthy Volunteers
Medical subject headings: Pruritus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02639052
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Baseline, 1 week, 1 month, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2016Jan 2017

First posted24 Dec 2015 (estimated)
Study startFeb 2016
Primary completionJul 2016
Study completionJan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (13)Papers the sponsor has linked to this study.
Other trials for PruritusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02639052
Sponsor's protocol ID: 23230
Other IDs: 126938
Status last verified: Mar 2017
First submitted: 18 Dec 2015
Last updated: 27 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 10906647
Hallett M. How does botulinum toxin work? Ann Neurol. 2000 Jul;48(1):7-8. No abstract available.
PubMed 10894209
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.
PubMed 10715374
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.
PubMed 14715398
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.
PubMed 11952288
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.
PubMed 12399757
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.
PubMed 11907521
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.
PubMed 14710908
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.
PubMed 19624547
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.
PubMed 9375459
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.
PubMed 12628475
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.
PubMed 18434511
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.
PubMed 21423808

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Active, not recruiting
Identification of the Mechanism of Non-histaminergic Itch Inducing Epigenetic Changes
Itch
Recruiting
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
Histamine, Cowhage
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
Recruiting
Topographical Distribution of Itch and Pain Receptors
Pain, Itch

All Pruritus trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Itch Relieving Effect of Botox: a Study in Healthy Subjects
ClinicalTrials.gov ID: NCT02639052
Acronym / sponsor ID: 23230
Conditions: Pruritus
Keywords: Itch, Botox, Healthy Volunteers
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Temple UniversityUniversity, hospital or other
Collaborators: Allergan
Study start: Feb 2016
Primary completion: Jul 2016 (actual)
Study completion: Jan 2017 (actual)
First posted: 24 Dec 2015 (estimated)
Results: Posted 27 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Botox	Experimental	Drug: Botox10 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	Placebo comparator	Drug: SalineSaline vehicle intradermally injected into the other forearm. The subject is blinded to which forearm receives the Botox and which forearm receives the saline vehicle.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (20 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Botox10 units of Botox will be intradermally injected into one 4x4cm area on the volar forearm on 1st study visit.	Drug	Botox
Saline10 units of the Saline vehicle will be intradermally injected into one 4x4cm area on the contralateral volar forearm on the 1st study visit.	Drug	Saline

Primary outcome

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.
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.
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.
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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 27 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Botox and Saline Vehicle Control	35	34

Primary outcome: Itch by VAS Itch Intensity at Baseline (Visit 1)

Time frame: Baseline (Visit 1). Mean (Standard Deviation). Unit: units on a scale

Measure	Botox n = 35	Saline n = 35
Baseline (Visit 1), 0 seconds	4.5 (2.8)	4.3 (2.8)
Baseline (Visit 1), 30 seconds	6.5 (2.6)	6.3 (2.3)
Baseline (Visit 1), 60 seconds	6.8 (2.2)	6.5 (2.1)
Baseline (Visit 1), 90 seconds	5.9 (2.1)	6.3 (1.5)
Baseline (Visit 1), 120 seconds	5.1 (2.2)	5.1 (2.0)
Baseline (Visit 1), 150 seconds	4.1 (2.2)	3.9 (2.1)
Baseline (Visit 1), 180 seconds	2.8 (2.0)	2.8 (1.8)
Baseline (Visit 1), 210 seconds	2.0 (1.6)	2.0 (1.8)

Botox vs Saline: p = 0.9704, ANOVA with Repeated Measures

Primary outcome: Itch by VAS Itch Intensity at 1 Week (Visit 2)

Time frame: 1 week from Baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Botox n = 35	Saline n = 35
1 Week (Visit 2), 0 seconds	3.3 (2.4)	4.0 (2.9)
1 Week (Visit 2), 30 seconds	5.4 (2.3)	6.7 (2.2)
1 Week (Visit 2), 60 seconds	5.9 (2.3)	6.9 (2.1)
1 Week (Visit 2), 90 seconds	4.9 (2.3)	6.1 (1.7)
1 Week (Visit 2), 120 seconds	3.7 (2.4)	4.8 (2.0)
1 Week (Visit 2), 150 seconds	2.7 (2.5)	3.8 (2.2)
1 Week (Visit 2), 180 seconds	2.0 (2.3)	2.7 (2.1)
1 Week (Visit 2), 210 seconds	1.4 (1.8)	1.9 (1.9)

Botox vs Saline: p <0.0001, ANOVA with Repeated Measures

Primary outcome: Itch by VAS Itch Intensity at 1 Month (Visit 3)

Time frame: 1 Month from Baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Botox n = 35	Saline n = 35
1 Month (Visit 3), 0 seconds	3.2 (2.6)	3.8 (2.8)
1 Month (Visit 3), 30 seconds	5.0 (2.6)	6.2 (2.4)
1 Month (Visit 3), 60 seconds	5.1 (2.3)	6.2 (1.8)
1 Month (Visit 3), 90 seconds	4.3 (2.3)	5.7 (2.3)
1 Month (Visit 3), 120 seconds	3.5 (2.0)	4.5 (2.4)
1 Month (Visit 3), 150 seconds	2.3 (1.8)	3.3 (2.2)
1 Month (Visit 3), 180 seconds	1.5 (1.4)	2.2 (2.1)
1 Month (Visit 3), 210 seconds	0.9 (1.3)	1.4 (1.7)

Botox vs Saline: p <0.0001, ANOVA with Repeated Measures

Primary outcome: Itch by VAS Itch Intensity at 3 Months (Visit 4)

Time frame: 3 Months from Baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Botox n = 34	Saline n = 34
3 Months (Visit 4), 0 seconds	2.3 (1.8)	3.3 (2.4)
3 Months (Visit 4), 30 seconds	4.5 (2.5)	5.4 (2.5)
3 Months (Visit 4), 60 seconds	4.9 (2.3)	5.9 (2.2)
3 Months (Visit 4), 90 seconds	4.6 (2.3)	5.2 (2.1)
3 Months (Visit 4), 120 seconds	3.8 (2.0)	4.7 (2.1)
3 Months (Visit 4), 150 seconds	3.0 (2.0)	3.6 (2.1)
3 Months (Visit 4), 180 seconds	2.1 (1.9)	2.8 (1.9)
3 Months (Visit 4), 210 seconds	1.5 (1.7)	1.9 (1.9)

Botox vs Saline: p = 0.0004, ANOVA with Repeated Measures

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline, 1 week, 1 month, 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Botox	0 of 35 (0%)	0 of 35 (0%)	Not reported
Saline	0 of 35 (0%)	0 of 35 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 10906647Huang 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.
Background: PubMed 10894209Hallett M. How does botulinum toxin work? Ann Neurol. 2000 Jul;48(1):7-8. No abstract available.
Background: PubMed 10715374Ishikawa 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.
Background: PubMed 14715398Cui 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.
Background: PubMed 11952288Wollina 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.
Background: PubMed 12399757Swartling 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.
Background: PubMed 11907521Heckmann 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.
Background: PubMed 14710908Unal 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.
Background: PubMed 19624547Gazerani 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.
Background: PubMed 9375459Heyer 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.
Background: PubMed 12628475Wessler 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.
Background: PubMed 18434511Reddy 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gil Yosipovitch, MD principal investigator

Temple University

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Botox and Saline in people with Pruritus, run by Temple University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Itch by VAS Itch Intensity at Baseline (Visit 1) (time frame: Baseline (Visit 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02639052, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.