NCT03460158

Prospective Evaluation of Facial Cosmetic Procedures

Prospective Evaluation of Minimally Invasive Facial Cosmetic Procedures Through Measured Volumetric Changes and Patient Reported Outcomes

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Cosmetic Techniques

Interventions

Type	Name	Description
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.
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).
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.

Timeline

• Start date: 2020-08-21
• Primary completion: 2024-02-28
• Completion: 2024-05-29
• First posted: 2018-03-09
• Last updated: 2024-09-27
• Results posted: 2024-09-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study