NCT03460158

Brief Summary

A prospective, trial to quantitatively and qualitatively compare the dermal fillers for the treatment of age related aesthetic changes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2020

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
2.5 years until next milestone

Study Start

First participant enrolled

August 21, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2024

Completed
4 months until next milestone

Results Posted

Study results publicly available

September 27, 2024

Completed
Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

3.5 years

First QC Date

September 15, 2017

Results QC Date

May 7, 2024

Last Update Submit

September 23, 2024

Conditions

Cosmetic Techniques

Keywords

facial fillerRetylaneaesthetic improvementvolumizing fillers

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 week post injections

Secondary Outcomes (2)

  • Correlate Patient Satisfaction With Volumetric Measurements

    upto 90 days

  • Volumetric Changes of Treatment

    immediately post injection, 2 weeks, 4 weeks, and 12 weeks

Study Arms (1)

Restylane-L®, Restylane-L® Lyft, and Restylane Silk®

EXPERIMENTAL

Hyaluronic acid

Drug: Restylane-L®Drug: Restylane-L® LyftDrug: Restylane Silk®

Interventions

Restylane-L®DRUG

Restylane-L® for the indication for mid-to-deep dermal implantation for moderate to severe facial wrinkles and folds, such as nasolabial folds.

Also known as: Hyaluronic acid gel
Restylane-L®, Restylane-L® Lyft, and Restylane Silk®
Restylane-L® LyftDRUG

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).

Also known as: Hyaluronic acid gel
Restylane-L®, Restylane-L® Lyft, and Restylane Silk®
Restylane Silk®DRUG

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.

Also known as: Hyaluronic acid gel
Restylane-L®, Restylane-L® Lyft, and Restylane Silk®

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients 40 - 65 years of age

You may not qualify if:

  • Male patients
  • Prior surgical facial rejuvenation procedures
  • Facelift
  • Neck lift
  • Blepharoplasty
  • Facial fat grafting
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 40178806DERIVED

MeSH Terms

Interventions

Restylane-L

Results Point of Contact

Title
Ivona Percec, MD, PhD
Organization
University of Pennsylvania
ivona.percec@pennmedicine.upenn.edu
215-662-7300

Study Officials

  • Ivona Percec, MD,PhD

    University of Pennsylvania Health System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2017

First Posted

March 9, 2018

Study Start

August 21, 2020

Primary Completion

February 28, 2024

Study Completion

May 29, 2024

Last Updated

September 27, 2024

Results First Posted

September 27, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)