AgingPhase 4NCT00434863
Comparative Study of the Effect of Dysport and Botox
A Phase 4 study testing botulinum toxin type A in people with Aging, run by Laserklinik Karlsruhe at 1 site in Germany.
Trial summary
The purpose of this study is to test the effect of Dysport and Botox on forehead wrinkles and EMG activity. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- botulinum toxin type A
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2005to Mar 2006
- Phase
- Phase 4
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 30 and 70 years
- moderate to severe hyperfunctional forehead wrinkles at maximum contraction and at rest
Who cannot join
- application of botulinum toxin products for a period of 12 months prior to the study
- any significant health disturbances
- facial nerve palsy, and any facial conditions that could confound safety or efficacy results
- pregnancy and breast-feeding
- neuromuscular diseases
- drugs interfering with neuromuscular function (e.g. aminoglycosides)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Randomized Double-Blinded Study of the Effect of Dysport and Botox on Forehead Wrinkles and EMG Activity
The purpose of this study is to test the effect of Dysport and Botox on forehead wrinkles and EMG activity.
- Conditions
- Aging
- Being tested
- botulinum toxin type A
- Keywords
- botulinum toxin type A, Dysport®, Botox®, hyperfunctional forehead lines, randomized controlled trial, double-blinded trial, electromyogram (EMG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG Muscular Activity at baseline and 0.5, 1, 2, 4, 8 and 10 weeks after injection, followed by weekly examinations for a total observation period of 20 weeks
Frown Wrinkle Severity (photographs and questionnaire) at baseline and 0.5, 1, 2, 4, 8 and 10 weeks after injection, followed by weekly examinations for a total observation period of 20 weeks
Secondary outcomes (1)
Side Effects upon completion of the study (20 weeks after injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2007 (estimated)
- Study startOct 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Laserklinik Karlsruhe
- Sponsor type
- University, hospital or other
- Investigators
- Syrus Karsai, MD, Principal investigator, Laserklinik Karlsruhe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434863
- Sponsor's protocol ID
- CR-015-LK/2005
- Status last verified
- Feb 2007
- First submitted
- 12 Feb 2007
- Last updated
- 13 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Randomized Double-Blinded Study of the Effect of Dysport and Botox on Forehead Wrinkles and EMG Activity
- ClinicalTrials.gov ID
- NCT00434863
- Acronym / sponsor ID
- CR-015-LK/2005
- Conditions
- Aging
- Keywords
- botulinum toxin type A, Dysport®, Botox®, hyperfunctional forehead lines, randomized controlled trial, double-blinded trial, electromyogram (EMG)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- Laserklinik KarlsruheUniversity, hospital or other
- Study start
- Oct 2005
- Study completion
- Mar 2006
- First posted
- 13 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.
The purpose of this study is to test the effect of Dysport and Botox on forehead wrinkles and EMG activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age between 30 and 70 years
- moderate to severe hyperfunctional forehead wrinkles at maximum contraction and at rest
Key exclusion criteria (6 listed)
- application of botulinum toxin products for a period of 12 months prior to the study
- any significant health disturbances
- facial nerve palsy, and any facial conditions that could confound safety or efficacy results
- pregnancy and breast-feeding
- neuromuscular diseases
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 toxin type A | Drug | – |
Primary outcome
EMG Muscular Activity at baseline and 0.5, 1, 2, 4, 8 and 10 weeks after injection, followed by weekly examinations for a total observation period of 20 weeks
Frown Wrinkle Severity (photographs and questionnaire) at baseline and 0.5, 1, 2, 4, 8 and 10 weeks after injection, followed by weekly examinations for a total observation period of 20 weeks
1 secondary outcome
Side Effects upon completion of the study (20 weeks after injection)
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 13 Feb 2007.
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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.
Syrus Karsai, MD principal investigator
Laserklinik Karlsruhe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing botulinum toxin type A in people with Aging, run by Laserklinik Karlsruhe at 1 site in Germany.
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 2 inclusion and 6 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 13 Feb 2007. 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 Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
EMG Muscular Activity at baseline and 0.5, 1, 2, 4, 8 and 10 weeks after injection, followed by weekly examinations for a total observation period of 20 weeks. The study lists 2 primary outcomes in all. 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 13 Feb 2007.