PainNCT00628472
Novel Technique for Botulinum Toxin Injection to Minimize Patient Discomfort
A study testing botulinum type a in people with Pain, run by Henry Ford Health System at 1 site in United States.
Trial summary
This single blinded randomized pilot study was performed on 21 Caucasian females to determine if injections through follicular openings were less painful than traditional injections for cosmetic botulinum toxin type A injections. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- botulinum type a
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to May 2007
- 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 25 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- No prior history of botulinum toxin
- Age 25-55
Who cannot join
- Male
- Prior history of botulinum toxin
- Neuromuscular disorders
- Aminoglycoside therapy
Trial locations and contacts
1 site in 1 country.
About this study
This single blinded randomized pilot study was performed on 21 Caucasian females to determine if injections through follicular openings were less painful than traditional injections for cosmetic botulinum toxin type A injections.
Read the detailed description
Objective: To investigate whether injection of botulinum toxin type A is less painful if performed through follicular openings versus traditional non-specific approach.
Design: Prospective, randomized, single-blinded study.
Setting: Academic dermatology department.
Patients: A volunteer sample of twenty female patients aged 25-55 who had no prior history of botulinum toxin injection.
Intervention: Each patient received six randomized injections of botulinum toxin type A (Botox® Allergan). Two injections into the procerus muscle and two into each corrugator muscle. Three of the injections were performed through follicular openings and three were performed traditionally.
Main Outcome Measure: Patient discomfort on a 1-10 scale and direct comparison between the two injection techniques.
- Conditions
- Pain
- Being tested
- botulinum type a
- Keywords
- botulinum toxin a, botox, Decreasing botox injection pain, injections
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum type aDrug
Also called Botox
12 Units total were injected into 6 sites in the glabellar complex to determine if injecting through the follicle versus a traditional approach would decrease patient discomfort
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease pain on injection for treatment intervention assessed on a 10 point scale
Measured: At time of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startJan 2007
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David M. Ozog, Henry Ford Health System
- Investigators
- David M Ozog, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628472
- Sponsor's protocol ID
- IRB 4300
- Status last verified
- Apr 2024
- First submitted
- 25 Feb 2008
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Technique for Botulinum Toxin Injection to Minimize Patient Discomfort
- ClinicalTrials.gov ID
- NCT00628472
- Acronym / sponsor ID
- IRB 4300
- Conditions
- Pain
- Keywords
- botulinum toxin a, botox, Decreasing botox injection pain, injections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 5 Mar 2008 (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 single blinded randomized pilot study was performed on 21 Caucasian females to determine if injections through follicular openings were less painful than traditional injections for cosmetic botulinum toxin type A injections.
Detailed description
Objective: To investigate whether injection of botulinum toxin type A is less painful if performed through follicular openings versus traditional non-specific approach.
Design: Prospective, randomized, single-blinded study.
Setting: Academic dermatology department.
Patients: A volunteer sample of twenty female patients aged 25-55 who had no prior history of botulinum toxin injection.
Intervention: Each patient received six randomized injections of botulinum toxin type A (Botox® Allergan). Two injections into the procerus muscle and two into each corrugator muscle. Three of the injections were performed through follicular openings and three were performed traditionally.
Main Outcome Measure: Patient discomfort on a 1-10 scale and direct comparison between the two injection techniques.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female
- No prior history of botulinum toxin
- Age 25-55
Key exclusion criteria (4 listed)
- Male
- Prior history of botulinum toxin
- Neuromuscular disorders
- Aminoglycoside 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 |
|---|---|---|
| botulinum type aAlso: Botox12 Units total were injected into 6 sites in the glabellar complex to determine if injecting through the follicle versus a traditional approach would decrease patient discomfort | Drug | – |
Primary outcome
Decrease pain on injection for treatment intervention assessed on a 10 point scale
Time frame: At time of intervention
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 30 Apr 2024.
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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.
David M Ozog, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing botulinum type a in people with Pain, run by Henry Ford Health System at 1 site in United States.
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 3 inclusion and 4 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 30 Apr 2024. 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 United States. 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?
Decrease pain on injection for treatment intervention assessed on a 10 point scale (time frame: At time of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2024.