Facial BlushingPhase 4NCT00225069
Thoracoscopic Sympathectomy for Blushing
A Phase 4 study testing Level of sympathectomy in people with Facial Blushing, run by Odense University Hospital at 2 sites in Denmark.
Trial summary
To determine outcome and side effects following thoracoscopic sympathectomy in patients treated for disabling isolated facial blushing and investigate if there are any significant differences between two different routine procedures: T2 or T2-T3 sympathectomy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Facial Blushing
- What is being tested?
- Level of sympathectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2005to Jan 2012
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Isolated disabling facial blushing
- Over 18 years of age
- Willing to be randomized
Who cannot join
- Primary hyperhidrosis in palms or axillae
- Previous lung surgery
- Bradycardia
- Arrythmias
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Dept Cardiothoracic Surgery, Skejby Sygehus, Aarhus University Hospital
Aarhus, 8200
Dept Cardiothorcic Surgery, Odense University Hospital
Odense, 5000
About this study
Official title: Thoracoscopic Sympathectomy for Blushing. A Prospective Randomised Trial.
To determine outcome and side effects following thoracoscopic sympathectomy in patients treated for disabling isolated facial blushing and investigate if there are any significant differences between two different routine procedures: T2 or T2-T3 sympathectomy.
Read the detailed description
To determine the outcome and side effects following thoracoscopic sympathectomy in patients treated for disabling isolated facial blushing. In addition, following randomization investigate if there are any significant differences between two different routine procedures: T2 or T2-T3 sympathectomy. Includes QoL before and 12 months after surgery
- Conditions
- Facial Blushing
- Being tested
- Level of sympathectomy
- Keywords
- Facial blushing, Sympathectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Level of sympathectomyProcedure or surgery
T2 sympathectomy or T2-T3 sympathectomy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | T2 sympathectomy Receives: Procedure: Level of sympathectomy |
| 2 | Experimental | T2-T3 sympathectomy Receives: Procedure: Level of sympathectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of operation. Side effects: compensatory and gustatory sweating.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial BlushingStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Principal investigator, Peter B Licht, Odense University Hospital
- Investigators
- Peter B Licht, MD PhD, Principal investigator, Odense University HospitalHans K Pilegaard, MD, Study chair, Skejby Sygehus, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225069
- Sponsor's protocol ID
- TOPSY1-2005
- Status last verified
- Aug 2012
- First submitted
- 21 Sep 2005
- Last updated
- 23 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracoscopic Sympathectomy for Blushing. A Prospective Randomised Trial.
- ClinicalTrials.gov ID
- NCT00225069
- Acronym / sponsor ID
- TOPSY1-2005
- Conditions
- Facial Blushing
- Keywords
- Facial blushing, Sympathectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Sep 2005
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 23 Sep 2005 (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.
To determine outcome and side effects following thoracoscopic sympathectomy in patients treated for disabling isolated facial blushing and investigate if there are any significant differences between two different routine procedures: T2 or T2-T3 sympathectomy.
Detailed description
To determine the outcome and side effects following thoracoscopic sympathectomy in patients treated for disabling isolated facial blushing. In addition, following randomization investigate if there are any significant differences between two different routine procedures: T2 or T2-T3 sympathectomy. Includes QoL before and 12 months after surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Level of sympathectomyT2 sympathectomy |
| 2 | Experimental | Procedure: Level of sympathectomyT2-T3 sympathectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Isolated disabling facial blushing
- Over 18 years of age
- Willing to be randomized
Key exclusion criteria (5 listed)
- Primary hyperhidrosis in palms or axillae
- Previous lung surgery
- Bradycardia
- Arrythmias
- Pregnancy
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 |
|---|---|---|
| Level of sympathectomyT2 sympathectomy or T2-T3 sympathectomy | Procedure or surgery | 1, 2 |
Primary outcome
Effect of operation. Side effects: compensatory and gustatory sweating.
Time frame: 12 months after surgery
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 23 Aug 2012.
Related trials for Facial Blushing
Active, not recruitingPhase 4
Treatment of Facial Flushing With Botulinum Toxin A Injections
Facial Flushing
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.
Peter B Licht, MD PhD principal investigator
Odense University Hospital
Hans K Pilegaard, MD study chair
Skejby Sygehus, Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Level of sympathectomy in people with Facial Blushing, run by Odense University Hospital at 2 sites 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 3 inclusion and 5 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 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Effect of operation. Side effects: compensatory and gustatory sweating. (time frame: 12 months after surgery). 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 23 Aug 2012.