HealthyNCT00435682
To Study the Peripheral Effect of Botulinum Toxin-A (Botox-A) on Experimentally Induced Cutaneous Pain in Healthy Subjects
A study testing Botox (Allergan Inc., US) in people with Healthy, run by Aalborg University at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Botox (Allergan Inc., US)
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Mar 2007to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed and dated Written Informed Consent
- Male, 18 40 years of age
- No concomitant medical diseases or clinically significant abnormal findings based on the medical history and baseline physical examination, that could affect the conduct of the study, analysis of the data, or the safety of a subject, as determined by the investigator.
- In the opinion of the investigator, the subject clearly understands the intent of the study and is willing and able to comply with study instructions, is available for study visits and procedures and is anticipated to complete the entire study
Who cannot join
- Any medical condition that may put the subject at increased risk with exposure to Botox, such as myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function, including peripheral neuropathies.
- Concurrent use or use within 30 days of screening of aminoglycoside antibiotics, curare like agents or other agents that might interfere with neuromuscular function
- Known allergy or sensitivity to any of the ingredients in the study medication or any clinical supply materials.
- Current or previous participation in another investigational drug or device study within 30 days prior to screening.
- Current or previous use of any serotype of botulinum toxin, or anticipated need for treatment with or use of any serotype of botulinum toxin during the study (other than the study medication).
- Recent history of drug or alcohol abuse.
Show all 12Show fewer
- Indications which in the investigator's opinion, indicates inappropriate/illicit substance abuse, an underlying significant medical condition or which might interfere with the subject's participation in the study.
- Infection or dermatological condition at the sites of study medication injection or test site.
- Family history of hereditary neuropathy.
- Any disease associated with a peripheral neuropathy (diabetes, etc.)
- Anticipated need for a medical procedure, surgery or overnight hospitalization during the study
- Concurrent use of any drug
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
- Conditions
- Healthy
- Being tested
- Botox (Allergan Inc., US)
- Keywords
- The trial is performed on healthy normal males.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox (Allergan Inc., US)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the peripheral effect of Botox on capsaicin induced pain and related vasomotor responses.
Secondary outcomes (2)
To determine which peripheral nociceptors (pain sensitive nerve endings) are blocked by Botox.
To determine the effect of intradermal Botox on itch.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2007 (estimated)
- Study startMar 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital
- Investigators
- Lars - Arendt-Nielsen, Prof., Dr.Med.Sci., Ph.D., Study chair, Aalborg University, Center for Sensory-Motor Interaction (SMI)Asbjoern Mohr Drewes, MD, PhD, DMSc, Prof., Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435682
- Sponsor's protocol ID
- 2006-001251-35
- Status last verified
- Jan 2008
- First submitted
- 14 Feb 2007
- Last updated
- 8 Feb 2008
- Results posted
- No
Publications
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.
PubMed 16677761
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Peripheral Effect of Botulinum Toxin-A (Botox-A) on Experimentally Induced Cutaneous Pain in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00435682
- Acronym / sponsor ID
- 2006-001251-35
- Conditions
- Healthy
- Keywords
- The trial is performed on healthy normal males.
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Aalborg University Hospital
- Study start
- Mar 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 15 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed and dated Written Informed Consent
- Male, 18 40 years of age
- No concomitant medical diseases or clinically significant abnormal findings based on the medical history and baseline physical examination, that could affect the conduct of the study, analysis of the data, or the safety of a subject, as determined by the investigator.
- In the opinion of the investigator, the subject clearly understands the intent of the study and is willing and able to comply with study instructions, is available for study visits and procedures and is anticipated to complete the entire study
Key exclusion criteria (12 listed)
- Any medical condition that may put the subject at increased risk with exposure to Botox, such as myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function, including peripheral neuropathies.
- Concurrent use or use within 30 days of screening of aminoglycoside antibiotics, curare like agents or other agents that might interfere with neuromuscular function
- Known allergy or sensitivity to any of the ingredients in the study medication or any clinical supply materials.
- Current or previous participation in another investigational drug or device study within 30 days prior to screening.
- Current or previous use of any serotype of botulinum toxin, or anticipated need for treatment with or use of any serotype of botulinum toxin during the study (other than the study medication).
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 |
|---|---|---|
| Botox (Allergan Inc., US) | Drug | – |
Primary outcome
To determine the peripheral effect of Botox on capsaicin induced pain and related vasomotor responses.
2 secondary outcomes
To determine which peripheral nociceptors (pain sensitive nerve endings) are blocked by Botox.
To determine the effect of intradermal Botox on itch.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2008.
- Background: PubMed 16677761Gazerani 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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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.
Lars - Arendt-Nielsen, Prof., Dr.Med.Sci., Ph.D. study chair
Aalborg University, Center for Sensory-Motor Interaction (SMI)
Asbjoern Mohr Drewes, MD, PhD, DMSc, Prof. principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botox (Allergan Inc., US) in people with Healthy, run by Aalborg University at 1 site in Denmark.
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 4 inclusion and 12 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 8 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the peripheral effect of Botox on capsaicin induced pain and related vasomotor responses.. 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 NCT00435682, which also lists 1 linked publication.
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 8 Feb 2008.