Cosmetic TechniquesPhase 4NCT03460158
Prospective Evaluation of Facial Cosmetic Procedures
A Phase 4 study testing Restylane-L®, Restylane-L® Lyft and Restylane Silk® in people with Cosmetic Techniques, run by University of Pennsylvania at 1 site in United States.
Trial summary
A prospective, trial to quantitatively and qualitatively compare the dermal fillers for the treatment of age related aesthetic changes. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cosmetic Techniques
- What is being tested?
- Restylane-L®, Restylane-L® Lyft and Restylane Silk®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2020to 29 May 2024
- Phase
- Phase 4
- 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patients 40 - 65 years of age
Who cannot join
- Male patients
- Prior surgical facial rejuvenation procedures
- Facelift
- Neck lift
- Blepharoplasty
- Facial fat grafting
Show all 12Show fewer
- Prior minimally invasive rejuvenation procedure ≤ 12 months
- Known contraindications to devices or drugs used in this study
- Facial paralysis
- Congenital facial asymmetry
- Pregnant women
- Patient actively taking blood thinners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
About this study
Official title: Prospective Evaluation of Minimally Invasive Facial Cosmetic Procedures Through Measured Volumetric Changes and Patient Reported Outcomes
A prospective, trial to quantitatively and qualitatively compare the dermal fillers for the treatment of age related aesthetic changes.
Read the detailed description
Dermal fillers have been approved for the treatment of age related aesthetic changes, including facial volume loss, and attenuation of the static and dynamic rhytid. Despite widespread use of volumizing fillers there is little data quantifying the subjective benefit of these minimally invasive treatments from the patient perspective. Furthermore, there is little data comparing the subjective benefit with true objective volumetric results. Such data will provide much needed information for patient counselling and treatment optimization for patient perceived outcomes.
This study is to determine the patient reported outcomes of three different dermal fillers and establish the volumetric changes over 90 days. Screening will be performed during the patient's office visit. Approximately 100 patients will be enrolled. Patients will participate up to 90 days (Day 1, 14 days, 28 days, and 90 days).
- Conditions
- Cosmetic Techniques
- Being tested
- Restylane-L®, Restylane-L® Lyft, Restylane Silk®
- Keywords
- facial filler, Retylane, aesthetic improvement, volumizing fillers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane-L®Drug
Also called Hyaluronic acid gel
Restylane-L® for the indication for mid-to-deep dermal implantation for moderate to severe facial wrinkles and folds, such as nasolabial folds.
Restylane-L® LyftDrug
Also called Hyaluronic acid gel
Restylane-L® Lyft is for the indication of implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds and malars (cheek/cheek bone area).
Restylane Silk®Drug
Also called Hyaluronic acid gel
Restylane Silk® is for the indication for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21.
| Study group | Role | What they receive |
|---|---|---|
| Restylane-L®, Restylane-L® Lyft, and Restylane Silk® | Experimental | Hyaluronic acid Receives: Drug: Restylane-L®; Drug: Restylane-L® Lyft; Drug: Restylane Silk® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction With Validated FACE-Q Aesthetics Survey
Absolute Change of the Patient Satisfaction using the validated FACE-Q Aesthetics questionnaire for patient reported assessment of treatment by domain.
The absolute change from the patient reported outcome score prior to injection to the patient reported score immediate post-injection. Increase in numeric value indicates the larger patient reported improvement, except for psychosocial distress module where a decrease in numeric value indicates patient improvement. Maximum change 99 and Minimum Change 0.
Measured: 2 week post injections
Secondary outcomes (2)
Correlate Patient Satisfaction With Volumetric Measurements
Linear correlation of relative volumetric change over relative patient satisfaction scale change. These values are reported as correlation coefficients and are unit less.
Measured: upto 90 days
Volumetric Changes of Treatment
3-dimensional photography to measure volumetric changes in each treatment
Measured: immediately post injection, 2 weeks, 4 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start21 Aug 2020
- Primary completion28 Feb 2024
- Study completion29 May 2024
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cosmetic TechniquesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Sponsor
- Investigators
- Ivona Percec, MD,PhD, Principal investigator, University of Pennsylvania Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460158
- Sponsor's protocol ID
- 827003
- Status last verified
- Sep 2024
- First submitted
- 15 Sep 2017
- Last updated
- 27 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Davis HD, Mazzaferro D, Habarth-Morales TE, Messa CA 4th, Talwar AA, Desai AA, McAuliffe PB, Broach RB, Serletti JM, Percec I. A Large Prospective Volumetric and Patient-Reported Outcome Analysis of Hyaluronic Acid Facial Fillers. Plast Reconstr Surg. 2025 Oct 1;156(4):550-559. doi: 10.1097/PRS.0000000000012135. Epub 2025 Apr 1.
PubMed 40178806
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Minimally Invasive Facial Cosmetic Procedures Through Measured Volumetric Changes and Patient Reported Outcomes
- ClinicalTrials.gov ID
- NCT03460158
- Acronym / sponsor ID
- 827003
- Conditions
- Cosmetic Techniques
- Keywords
- facial filler, Retylane, aesthetic improvement, volumizing fillers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Posted 27 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, trial to quantitatively and qualitatively compare the dermal fillers for the treatment of age related aesthetic changes.
Detailed description
Dermal fillers have been approved for the treatment of age related aesthetic changes, including facial volume loss, and attenuation of the static and dynamic rhytid. Despite widespread use of volumizing fillers there is little data quantifying the subjective benefit of these minimally invasive treatments from the patient perspective. Furthermore, there is little data comparing the subjective benefit with true objective volumetric results. Such data will provide much needed information for patient counselling and treatment optimization for patient perceived outcomes.
This study is to determine the patient reported outcomes of three different dermal fillers and establish the volumetric changes over 90 days. Screening will be performed during the patient's office visit. Approximately 100 patients will be enrolled. Patients will participate up to 90 days (Day 1, 14 days, 28 days, and 90 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Restylane-L®, Restylane-L® Lyft, and Restylane Silk® | Experimental | Drug: Restylane-L®, Drug: Restylane-L® Lyft, Drug: Restylane Silk®Hyaluronic acid |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female patients 40 - 65 years of age
Key exclusion criteria (12 listed)
- Male patients
- Prior surgical facial rejuvenation procedures
- Facelift
- Neck lift
- Blepharoplasty
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-L®Also: Hyaluronic acid gelRestylane-L® for the indication for mid-to-deep dermal implantation for moderate to severe facial wrinkles and folds, such as nasolabial folds. | Drug | Restylane-L®, Restylane-L® Lyft, and Restylane Silk® |
| Restylane-L® LyftAlso: Hyaluronic acid gelRestylane-L® Lyft is for the indication of implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds and malars (cheek/cheek bone area). | Drug | Restylane-L®, Restylane-L® Lyft, and Restylane Silk® |
| Restylane Silk®Also: Hyaluronic acid gelRestylane Silk® is for the indication for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21. | Drug | Restylane-L®, Restylane-L® Lyft, and Restylane Silk® |
Primary outcome
Patient Satisfaction With Validated FACE-Q Aesthetics Survey
Time frame: 2 week post injections
Absolute Change of the Patient Satisfaction using the validated FACE-Q Aesthetics questionnaire for patient reported assessment of treatment by domain. The absolute change from the patient reported outcome score prior to injection to the patient reported score immediate post-injection. Increase in numeric value indicates the larger patient reported improvement, except for psychosocial distress module where a decrease in numeric value indicates patient improvement. Maximum change 99 and Minimum Change 0.
2 secondary outcomes
Correlate Patient Satisfaction With Volumetric Measurements
Time frame: upto 90 days
Volumetric Changes of Treatment
Time frame: immediately post injection, 2 weeks, 4 weeks, and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40178806Davis HD, Mazzaferro D, Habarth-Morales TE, Messa CA 4th, Talwar AA, Desai AA, McAuliffe PB, Broach RB, Serletti JM, Percec I. A Large Prospective Volumetric and Patient-Reported Outcome Analysis of Hyaluronic Acid Facial Fillers. Plast Reconstr Surg. 2025 Oct 1;156(4):550-559. doi: 10.1097/PRS.0000000000012135. Epub 2025 Apr 1.
- Individual participant dataSharing planned: No
Related trials for Cosmetic Techniques
Recruiting
Post-Operative Cesarean Section Cosmesis
Cesarean Delivery
Recruiting
Comparison of Two Methods of Covering a Single Lower Front Tooth With Receded Gums
Recession, Gingival
Enrolling by invitation
Rate of Allergic Contact Dermatitis and Cosmetic Outcomes
Allergic Contact Dermatitis, Osteoarthritis, Hip
Not yet recruitingObservational study
Pain Beliefs and Functional Performance After Cosmetic Limb Lengthening Using the Lengthening Over Nail (LON) Technique
Postoperative Pain After Limb Lengthening, Limb Lengthening
Enrolling by invitationObservational study
Expert Consensus on the Clinical Use of Skin Boosters: A Delphi-Based Recommendation Framework
Aesthetic Procedures, Cosmetic Techniques
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.
Ivona Percec, MD,PhD principal investigator
University of Pennsylvania Health System
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 Restylane-L®, Restylane-L® Lyft and Restylane Silk® in people with Cosmetic Techniques, run by University of Pennsylvania 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 1 inclusion and 12 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 Sep 2024. 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.
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?
Yes. Results are posted in the registry (first posted 27 Sep 2024). 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?
Patient Satisfaction With Validated FACE-Q Aesthetics Survey (time frame: 2 week post injections). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03460158, which also lists 1 linked publication.
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 Sep 2024.