PainSCWNCT02347826
Evaluation of Satisfaction in Patients Undergoing Non Surgical Lifting by Means of Coned Wires.
An observational study of Pain and Complications, run by AQ-DE at 1 site in Italy.
Trial summary
An email questionnaire about subjective satisfaction and discomfort has been sent to 243 patients undergoing non-surgical facial and cervical lift 1 week, 1 month, 6 months and 1 year after treatment. Read more about this study
- Who is it for?
- Ages 19 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Complications
- How many people
- 243 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Dec 2014
- Phase
- Observational
- 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 19 to 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing non surgical facial and carvical lift from 2013 to 2014
Who may be able to join
- Patients undergoing facial and cervical non surgical lift by means of resorbable coned wires
Who cannot join
- Patients with asymmetry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Aesthetic Satisfaction in Patients Undergoing Non Surgical Face and Neck Lift by Means of Coned Wires.
An email questionnaire about subjective satisfaction and discomfort has been sent to 243 patients undergoing non-surgical facial and cervical lift 1 week, 1 month, 6 months and 1 year after treatment.
Read the detailed description
243 patients underwent non-surgical coned wires (silhouette soft) facial and cervical lift between October 2013 and November 2014. The procedures has been executed in our aesthetic clinics in Milan, Bologna, Turin, Genoa, Rome, Asti, San Remo and Palermo.
Among the 243 patients, 217 were females and 26 males, with age ranging from 19 to 76 years. 103 patients underwent only facial lift, of which 12 only in the frontal area, 61 only on cheek and malar area, and 30 on both the areas.
39 patients underwent only cervical lift, of those 14 by means of appliance of 1 or 2 wires, 25 by means of appliance of more than 2 wires.
101 patients underwent both facial and cervical non surgical lift. We sent to every patient a email questionnaire1 week, 1 month, 6 months and 1 year after treatment.
In the questionnaire, patients has been asked to enter a value between 1 and 5 about subjective satisfaction regarding the aesthetic improvement (ranging from 1, poor, to 5, excellent), and discomfort related to treatment (ranging from 1, no perceived discomfort, to 5, impossibility to execute working and social activities).
The data has been analyzed and related to other factors such as:
- number of wires applied on each patient
- other aesthetic or regenerative medicine treatments executed on the same patient on the same year
- total expenditure related to aesthetic treatments in the same year
- Conditions
- Pain, Complications
- Keywords
- coned wires, wire lift,, patient, discomfort
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective satisfaction questionnaire
Measured: up to one year
Secondary outcomes (1)
Discomfort related to treatment questionnaire
Measured: one week, one month, 6 months, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startJan 2014
- Primary completionJan 2014
- Study completionDec 2014
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.
- 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- AQ-DE
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mario Goisis, MS, Study director, AQ-DE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347826
- Sponsor's protocol ID
- Aqde
- Acronym
- SCW
- Status last verified
- Jan 2015
- First submitted
- 21 Jan 2015
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Aesthetic Satisfaction in Patients Undergoing Non Surgical Face and Neck Lift by Means of Coned Wires.
- ClinicalTrials.gov ID
- NCT02347826
- Acronym / sponsor ID
- SCW / Aqde
- Conditions
- Pain, Complications
- Keywords
- coned wires, wire lift,, patient, discomfort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- AQ-DEUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Jan 2015 (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.
An email questionnaire about subjective satisfaction and discomfort has been sent to 243 patients undergoing non-surgical facial and cervical lift 1 week, 1 month, 6 months and 1 year after treatment.
Detailed description
243 patients underwent non-surgical coned wires (silhouette soft) facial and cervical lift between October 2013 and November 2014. The procedures has been executed in our aesthetic clinics in Milan, Bologna, Turin, Genoa, Rome, Asti, San Remo and Palermo.
Among the 243 patients, 217 were females and 26 males, with age ranging from 19 to 76 years. 103 patients underwent only facial lift, of which 12 only in the frontal area, 61 only on cheek and malar area, and 30 on both the areas.
39 patients underwent only cervical lift, of those 14 by means of appliance of 1 or 2 wires, 25 by means of appliance of more than 2 wires.
101 patients underwent both facial and cervical non surgical lift. We sent to every patient a email questionnaire1 week, 1 month, 6 months and 1 year after treatment.
In the questionnaire, patients has been asked to enter a value between 1 and 5 about subjective satisfaction regarding the aesthetic improvement (ranging from 1, poor, to 5, excellent), and discomfort related to treatment (ranging from 1, no perceived discomfort, to 5, impossibility to execute working and social activities).
The data has been analyzed and related to other factors such as:
- number of wires applied on each patient
- other aesthetic or regenerative medicine treatments executed on the same patient on the same year
- total expenditure related to aesthetic treatments in the same year
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing non surgical facial and carvical lift from 2013 to 2014
Key inclusion criteria (1 listed)
- Patients undergoing facial and cervical non surgical lift by means of resorbable coned wires
Key exclusion criteria (1 listed)
- Patients with asymmetry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subjective satisfaction questionnaire
Time frame: up to one year
1 secondary outcome
Discomfort related to treatment questionnaire
Time frame: one week, one month, 6 months, one year
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 28 Jan 2015.
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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.
Mario Goisis, MS study director
AQ-DE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Complications, run by AQ-DE at 1 site in Italy.
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 1 inclusion and 1 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 28 Jan 2015. 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 Italy. 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?
Subjective satisfaction questionnaire (time frame: up to one year). 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 28 Jan 2015.