Lip RejuvenationNCT03241862
Assess the Impact of Lip Rejuvenation on Projected First Impressions and Mood Perceptions
A study testing Restylane® Silk in people with Lip Rejuvenation, run by DeNova Research at 1 site in United States.
Trial summary
20 subjects with mild to severe oral commissures or none to severe perioral lines will be enrolled and injected with Restylane® Silk. Photographs will be taken prior to and 14 days after Optimal Cosmetic Results has been achieved, as judged by the investigator. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lip Rejuvenation
- What is being tested?
- Restylane® Silk
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 16 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is an adult of at least 21 years of age;
- Subject has mild to severe oral commissures or none to severe perioral lines, as assessed by the treating investigator;
- Subject is willing and able to provide written informed consent prior to the performance of any study related procedure;
- Subject is willing and able to comply with the protocol requirements; and
- Subject is willing and able to provide written photo consent and adhere to the photography and video procedures such as removal of jewelry and makeup
Who cannot join
- Subjects who have received lip filler treatments in the past 12 months or neurotoxin injections in the past 6 months;
- Subjects who plan to undergo neurotoxin treatments, ablative skin treatments, facial cosmetic surgery, or other injectable filler treatments during the course of the study;
- Subjects with a known allergy or sensitivity to any component of the study ingredients;
- Subjects with a history of bleeding disorders;
- Female subjects who are pregnant or nursing as well as those who are of childbearing potential but do not employ adequate birth control methods;
- Subjects with severe allergies manifested by a history of anaphylaxis or presence of multiple severe allergies;
Show all 11Show fewer
- Subjects with previous history of sensitivity to amide type local anesthetics;
- Current history of chronic drug or alcohol abuse;
- Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study product;
- Subjects who, in the investigator's opinion, have a history of poor cooperation, non-compliance with medical treatment, or unreliability; and
- Enrollment in any active study involving the use of investigational devices or drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assess the Impact of Lip Rejuvenation With Restylane® Silk on Projected First Impressions and Mood Perceptions
20 subjects with mild to severe oral commissures or none to severe perioral lines will be enrolled and injected with Restylane® Silk. Photographs will be taken prior to and 14 days after Optimal Cosmetic Results has been achieved, as judged by the investigator.
Changes in the projected first impression will be assessed by a total of 200 blinded evaluators rating the photographs of subjects from the baseline and from 14 days post achieving the Optimal Cosmetic Results. Changes in subjects' mood will be self-assessed through Subjective Happiness Scale and Happiness Measures questionnaires. Aesthetic alterations will be assessed by the investigator via the Global Aesthetic Improvement Scale, Oral Commissure Severity Scale, and the Perioral Lines Severity Scale as well as by the self-assessment of subjects using the Global Aesthetic Improvement Scale.
- Conditions
- Lip Rejuvenation
- 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
Restylane® Silk (Galderma Laboratories, L.P.) is a hyaluronic acid injectable filler, which is approved by the FDA for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids.
| Study group | Role | What they receive |
|---|---|---|
| Restylane® Silk | Experimental | All subjects enrolled in the study will undergo lip rejuvenation treatment with Restylane® Silk. Receives: Device: Restylane® Silk |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Impressions
The projected first impressions are assessed by blinded evaluators using photographs.
The projected first impressions are assessed by blinded evaluators using the First Impression Questionnaire (FIQ).
Each of the below First Impression Questionnaire (FIQ) categories is scored between 1 (disagree)-10 (agree) and a total of 8 categories (see below) are assessed for a total possible score of 80. All scores will be graded out of a total possible score of 80 points Social skills Academic Performance Dating Success Occupational success Attractiveness Financial Success Relationship success Athletic success Total scores closer to 80 indicate a more favorable outcome.
Measured: 1 month
Secondary outcomes (1)
Appearance of the Lip and Perioral Area
Changes in the appearance of the lip and the perioral area are assessed by the PI using the Oral Commissure Severity Scale (OCSS) at Visit 1 and Visit 3/4
Oral Commissure Severity Scale (OCSS): graded from None (0), Mild (1), Moderate (2), Severe (3)
None: No wrinkle or fold; slight upturned commissures Mild: Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners Moderate: Moderately deep and/or long wrinkle or crease; downturned corners Severe: Very deep and/or long wrinkle or crease; frown at rest
Measured: Visit 1 at Baseline and Visit 3 (Week 4) or Visit 4 (Week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study startSep 2015
- Primary completionJun 2017
- Study completion16 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lip RejuvenationStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- DeNova Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven H Dayan, MD, Principal investigator, DeNova Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241862
- Sponsor's protocol ID
- Silk-FI-01
- Status last verified
- Nov 2020
- First submitted
- 14 Sep 2015
- Last updated
- 4 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assess the Impact of Lip Rejuvenation With Restylane® Silk on Projected First Impressions and Mood Perceptions
- ClinicalTrials.gov ID
- NCT03241862
- Acronym / sponsor ID
- Silk-FI-01
- Conditions
- Lip Rejuvenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- DeNova ResearchUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- 16 Jun 2017 (actual)
- First posted
- 8 Aug 2017 (actual)
- Results
- Posted 4 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
20 subjects with mild to severe oral commissures or none to severe perioral lines will be enrolled and injected with Restylane® Silk. Photographs will be taken prior to and 14 days after Optimal Cosmetic Results has been achieved, as judged by the investigator.
Changes in the projected first impression will be assessed by a total of 200 blinded evaluators rating the photographs of subjects from the baseline and from 14 days post achieving the Optimal Cosmetic Results. Changes in subjects' mood will be self-assessed through Subjective Happiness Scale and Happiness Measures questionnaires. Aesthetic alterations will be assessed by the investigator via the Global Aesthetic Improvement Scale, Oral Commissure Severity Scale, and the Perioral Lines Severity Scale as well as by the self-assessment of subjects using the Global Aesthetic Improvement Scale.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Restylane® Silk | Experimental | Device: Restylane® SilkAll subjects enrolled in the study will undergo lip rejuvenation treatment with Restylane® Silk. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is an adult of at least 21 years of age;
- Subject has mild to severe oral commissures or none to severe perioral lines, as assessed by the treating investigator;
- Subject is willing and able to provide written informed consent prior to the performance of any study related procedure;
- Subject is willing and able to comply with the protocol requirements; and
- Subject is willing and able to provide written photo consent and adhere to the photography and video procedures such as removal of jewelry and makeup
Key exclusion criteria (11 listed)
- Subjects who have received lip filler treatments in the past 12 months or neurotoxin injections in the past 6 months;
- Subjects who plan to undergo neurotoxin treatments, ablative skin treatments, facial cosmetic surgery, or other injectable filler treatments during the course of the study;
- Subjects with a known allergy or sensitivity to any component of the study ingredients;
- Subjects with a history of bleeding disorders;
- Female subjects who are pregnant or nursing as well as those who are of childbearing potential but do not employ adequate birth control methods;
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® SilkRestylane® Silk (Galderma Laboratories, L.P.) is a hyaluronic acid injectable filler, which is approved by the FDA for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids. | Device | Restylane® Silk |
Primary outcome
First Impressions
Time frame: 1 month
The projected first impressions are assessed by blinded evaluators using photographs. The projected first impressions are assessed by blinded evaluators using the First Impression Questionnaire (FIQ). Each of the below First Impression Questionnaire (FIQ) categories is scored between 1 (disagree)-10 (agree) and a total of 8 categories (see below) are assessed for a total possible score of 80. All scores will be graded out of a total possible score of 80 points Social skills Academic Performance Dating Success Occupational success Attractiveness Financial Success Relationship success Athletic success Total scores closer to 80 indicate a more favorable outcome.
1 secondary outcome
Appearance of the Lip and Perioral Area
Time frame: Visit 1 at Baseline and Visit 3 (Week 4) or Visit 4 (Week 6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Lip Rejuvenation
RecruitingObservational study
Prospective, Non-interventional Study Assessing Perioral Rejuvenation Procedure
Perioral Wrinkles, Crow's Feet
Active, not recruitingObservational study
Performance and Safety of Semical Dermal Fillers in Facial Rejuvenation
Facial Aging, Skin Rejuvenation
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.
Steven H Dayan, MD principal investigator
DeNova Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane® Silk in people with Lip Rejuvenation, run by DeNova Research 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 5 inclusion and 11 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 4 Nov 2020. 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?
Yes. Results are posted in the registry (first posted 4 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
First Impressions (time frame: 1 month). 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 4 Nov 2020.