Smile LinesNCT02636894
Evaluation of the Efficacy of Restylane Silk in the Treatment of Cheek Fold (Radial Smile Lines)
A study testing Restylane Silk in people with Smile Lines, run by Amanda D. Spear, CCRC.
Trial summary
Filler study for smile lines in cheek folds Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smile Lines
- What is being tested?
- Restylane Silk
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Aug 2016
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female between 21-65 years of age
- Willing to comply with study visits and procedures
- Willingness to refrain form surgical, laser, or injectable treatments in cheek region during study
Who cannot join
- History of trauma, acne scarring, burns, or other changes to skin in treatment area
- Use of botulinum toxin in the lateral cheeks/perioral region in past 6 months
- Use of injectable fillers in the lateral cheeks/perioral within last 2 years
- History of facelift in the last year
- History of facial nerve palsy
About this study
Filler study for smile lines in cheek folds
- Conditions
- Smile Lines
- Being tested
- Restylane Silk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane SilkDevice
| Study group | Role | What they receive |
|---|---|---|
| Restylane Silk | Other | Restylane Silk Receives: Device: Restylane Silk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the Efficacy of Restylane Silk in the Treatment of Cheek folds (Radial Smile Lines)
Improvement of subjects based on 5 point global aesthetic scale (GAIS)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startMar 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smile LinesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amanda D. Spear, CCRC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amanda D. Spear, CCRC, Nashville Centre for Laser and Facial Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636894
- Sponsor's protocol ID
- Restylane Silk
- Status last verified
- Mar 2019
- First submitted
- 16 Dec 2015
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Restylane Silk in the Treatment of Cheek Fold (Radial Smile Lines)
- ClinicalTrials.gov ID
- NCT02636894
- Acronym / sponsor ID
- Restylane Silk
- Conditions
- Smile Lines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Amanda D. Spear, CCRCUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 22 Dec 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.
Filler study for smile lines in cheek folds
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Restylane Silk | Other | Device: Restylane SilkRestylane Silk |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female between 21-65 years of age
- Willing to comply with study visits and procedures
- Willingness to refrain form surgical, laser, or injectable treatments in cheek region during study
Key exclusion criteria (5 listed)
- History of trauma, acne scarring, burns, or other changes to skin in treatment area
- Use of botulinum toxin in the lateral cheeks/perioral region in past 6 months
- Use of injectable fillers in the lateral cheeks/perioral within last 2 years
- History of facelift in the last year
- History of facial nerve palsy
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 |
|---|---|---|
| Restylane Silk | Device | Restylane Silk |
Primary outcome
Evaluation of the Efficacy of Restylane Silk in the Treatment of Cheek folds (Radial Smile Lines)
Time frame: 6 months
Improvement of subjects based on 5 point global aesthetic scale (GAIS)
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 27 Mar 2019.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane Silk in people with Smile Lines, run by Amanda D. Spear, CCRC.
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 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Evaluation of the Efficacy of Restylane Silk in the Treatment of Cheek folds (Radial Smile Lines) (time frame: 6 months). 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 27 Mar 2019.