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| Name | Class |
|---|---|
| Aalborg University Hospital | OTHER |
This is a human trial to study the peripheral effect of therapeutic botulinum toxin (botox-A). The trial is performed on healthy normal males. The study comprises of two parallel placebo-controlled, double blinded studies.
In experiment 1 intramuscular Botox will be given in corrugator (one site) and frontalis (two sites) muscles on one side and placebo to the other side. Intradermal (i.d.) capsaicin injection will be given to both sides (between the two sites of frontalis injection horizontally). Capsaicin-induced pain intensity and flare together with the area of hypersensitivity to different stimulus modalities will be measured and mapped at specific time points using different cutaneous stimuli (thermal, electrical, tactile, pressure). This will characterize which fibres and receptors are affected by Botox and will show if Botox have a unilateral effect (peripheral) or if it also affects the contralateral side (central effect).
In experiment 2 intradermal Botox will be given in corrugator (one site) and frontalis (two sites) muscles on one side and placebo to the other side. I.d. capsaicin injection will be given to both sides (between the two sites of frontalis injection horizontally). Capsaicin-induced pain intensity and flare together with the area of hypersensitivity to different stimulus modalities will be measured and mapped at specific time points using different cutaneous stimuli (thermal, electrical, tactile, pressure). This will characterize which fibres and receptors are affected by Botox. The effect of intradermal Botox will be compared to the results of experiment 1.
The two experiments will show if the intramuscular Botox exerts its action via a leak of Botox from the muscle to the overlying skin.
Antipruritic effects of Botox on histamine prick test and itch will also be assessed in parallel with the experiment 2. In this sub-experiment, 5 Units of Botox will be injected intradermally in the middle of volar forearm. The same volume of placebo will be injected into the other side. Histamine prick test will induce itch and the effect of intradermal Botox will be assessed compared to the baseline. Flare area and visual analogue scale (VAS) ratings will be measured.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botox (Allergan Inc., US) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the peripheral effect of Botox on capsaicin induced pain and related vasomotor responses. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine which peripheral nociceptors (pain sensitive nerve endings) are blocked by Botox. | ||
| To determine the effect of intradermal Botox on itch. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars - Arendt-Nielsen, Prof., Dr.Med.Sci., Ph.D. | Aalborg University, Center for Sensory-Motor Interaction (SMI) | Study Chair |
| Asbjoern Mohr Drewes, MD, PhD, DMSc, Prof. | Aalborg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16677761 | Background | Gazerani P, Staahl C, Drewes AM, Arendt-Nielsen L. The effects of Botulinum Toxin type A on capsaicin-evoked pain, flare, and secondary hyperalgesia in an experimental human model of trigeminal sensitization. Pain. 2006 Jun;122(3):315-325. doi: 10.1016/j.pain.2006.04.014. Epub 2006 May 4. |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| 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 |