Prospective Evaluation of Facial Cosmetic Procedures

University of Pennsylvania

Status and phase: Completed; Phase 4

Conditions: Cosmetic Techniques

Treatments: Drug: Restylane-L®; Drug: Restylane-L® Lyft; Drug: Restylane Silk®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03460158

827003

Details and patient eligibility

About

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

Full 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).

Enrollment: 101 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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101 participants in 1 patient group

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

Experimental group

Description:

Hyaluronic acid

Treatment:

Drug: Restylane Silk®

Drug: Restylane-L® Lyft

Drug: Restylane-L®