Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 126938 | Other Identifier | FDA IND |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Allergan | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botox | Drug | 10 units of Botox will be intradermally injected into one 4x4cm area on the volar forearm on 1st study visit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gil Yosipovitch, MD | Temple University | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10906647 | Background | 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. | |
| 10894209 | Background | Hallett M. How does botulinum toxin work? Ann Neurol. 2000 Jul;48(1):7-8. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Botox and Saline Vehicle Control | 10 units of both Botox and a saline vehicle will be intradermally injected into one forearm or the other on the first study visit. The subject will be blinded to which forearm receives the Botox and which forearm receives the saline vehicle. Botox: 10 units of Botox will be intradermally injected into one 4x4cm area on the volar forearm on 1st study visit. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Botox and Saline Vehicle Control | 10 units of both Botox and a saline vehicle will be intradermally injected into one forearm or the other on the first study visit. The subject will be blinded to which forearm receives the Botox and which forearm receives the saline vehicle. Botox: 10 units of Botox will be intradermally injected into one 4x4cm area on the volar forearm on 1st study visit. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Visit 1) |
|
Baseline, 1 week, 1 month, 3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Botox | 10 units of Botox intradermally injected into one forearm |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan G. Fisher, M.S., Ph.D., Associate Dean and Director, Temple Clinical Research Institute | Lewis Katz School of Medicine at Temple University | 215-707-3577 | susan.fisher@tuhs.temple.edu |
Not provided
| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| Baseline, 1 week, 1 month, 3 months |
| 10715374 | 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. |
| 14715398 | 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. |
| 11952288 | 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. |
| 12399757 | 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. |
| 11907521 | 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. |
| 14710908 | 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. |
| 19624547 | 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. |
| 9375459 | 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. |
| 12628475 | 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. |
| 18434511 | 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. |
| 21423808 | 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 1 week from Baseline |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 1 Month from Baseline |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 Months from Baseline |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 week, 1 month, 3 months |
|
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Saline | Saline vehicle intradermally injected into the other forearm | 0 | 35 | 0 | 35 |
Not provided
Not provided
Not provided
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| 1 Week (Visit 2), 60 seconds |
|
| 1 Week (Visit 2), 90 seconds |
|
| 1 Week (Visit 2), 120 seconds |
|
| 1 Week (Visit 2), 150 seconds |
|
| 1 Week (Visit 2), 180 seconds |
|
| 1 Week (Visit 2), 210 seconds |
|
| 1 Week (Visit 2), 240 seconds |
|
| 1 Week (Visit 2), 270 seconds |
|
| 1 Week (Visit 2), 300 seconds |
|
| 1 Week (Visit 2), All Times |
|
| 1 Month (Visit 3), 60 seconds |
|
| 1 Month (Visit 3), 90 seconds |
|
| 1 Month (Visit 3), 120 seconds |
|
| 1 Month (Visit 3), 150 seconds |
|
| 1 Month (Visit 3), 180 seconds |
|
| 1 Month (Visit 3), 210 seconds |
|
| 1 Month (Visit 3), 240 seconds |
|
| 1 Month (Visit 3), 270 seconds |
|
| 1 Month (Visit 3), 300 seconds |
|
| 1 Month (Visit 3), All Times |
|
| 3 Months (Visit 4), 60 seconds |
|
| 3 Months (Visit 4), 90 seconds |
|
| 3 Months (Visit 4), 120 seconds |
|
| 3 Months (Visit 4), 150 seconds |
|
| 3 Months (Visit 4), 180 seconds |
|
| 3 Months (Visit 4), 210 seconds |
|
| 3 Months (Visit 4), 240 seconds |
|
| 3 Months (Visit 4), 270 seconds |
|
| 3 Months (Visit 4), 300 seconds |
|
| 3 Months (Visit 4), All Times |
|
| 1 Month |
|
| 3 Months |
|
| All Visits |
|