Prospective Evaluation of Facial Cosmetic Procedures

Phase 4

Completed

• Conditions: Cosmetic Techniques
• Interventions: Drug: Restylane-L®; Drug: Restylane-L® Lyft; Drug: Restylane Silk®

• Registration Number: NCT03460158
• Lead Sponsor: University of Pennsylvania

Brief Summary

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 Timeline

• Study First Submitted: 2017-09-15
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-09
• Study Start: 2020-08-21
• Primary Completion: 2024-02-28
• Results First Submitted: 2024-05-07
• Study Completion: 2024-05-29
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-23
• Last Update Submitted: 2024-09-23
• Results First Posted: 2024-09-27
• Last Update Posted: 2024-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 101

Inclusion Criteria

• Female patients 40 - 65 years of age

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Restylane-L®, Restylane-L® Lyft, and Restylane Silk®	Restylane-L®	Hyaluronic acid
Restylane-L®, Restylane-L® Lyft, and Restylane Silk®	Restylane-L® Lyft	Hyaluronic acid
Restylane-L®, Restylane-L® Lyft, and Restylane Silk®	Restylane Silk®	Hyaluronic acid

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction With Validated FACE-Q Aesthetics Survey	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.

Secondary Outcome Measures

Name	Time	Method
Correlate Patient Satisfaction With Volumetric Measurements	upto 90 days	Linear correlation of relative volumetric change over relative patient satisfaction scale change. These values are reported as correlation coefficients and are unit less.
Volumetric Changes of Treatment	immediately post injection, 2 weeks, 4 weeks, and 12 weeks	3-dimensional photography to measure volumetric changes in each treatment

Trial Locations

Locations (1)

University of Pennsylvania Health System; 🇺🇸 Philadelphia, Pennsylvania, United States