Prospective Evaluation of Facial Cosmetic Procedures

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.

Study Overview

• Status: Completed
• Conditions: Cosmetic Techniques
• Intervention / Treatment: Drug: Restylane-L®; Drug: Restylane-L® Lyft; Drug: Restylane Silk®

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 Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Female patients 40 - 65 years of age

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Restylane-L®, Restylane-L® Lyft, and Restylane Silk®; Hyaluronic acid

Drug: Restylane-L®; Restylane-L® for the indication for mid-to-deep dermal implantation for moderate to severe facial wrinkles and folds, such as nasolabial folds.; Other Names: Hyaluronic acid gel; Drug: Restylane-L® Lyft; 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).; Other Names: Hyaluronic acid gel; Drug: Restylane Silk®; 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.; Other Names: Hyaluronic acid gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	upto 90 days
Volumetric Changes of Treatment	3-dimensional photography to measure volumetric changes in each treatment	immediately post injection, 2 weeks, 4 weeks, and 12 weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Galderma R&D
• Investigators: Principal Investigator: Ivona Percec, MD,PhD, University of Pennsylvania Health System

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2020
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): May 29, 2024

Study Registration Dates

• First Submitted: September 15, 2017
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (Actual): March 9, 2018

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: facial filler; Retylane; aesthetic improvement; volumizing fillers
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 827003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No