Prospective Evaluation of Facial Cosmetic Procedures

Cosmetic Techniques Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03460158
• Other study ID #: 827003
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: August 21, 2020
• Est. completion date: February 29, 2024

Study information

• Verified date: January 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 101
• Est. completion date: February 29, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cosmetic Techniques

Intervention

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.
• 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).
• 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction with validated FACE-Q survey	Patient satisfaction with validated survey FACE-Q	upto 90 days
Secondary	Correlate patient satisfaction with volumetric measurements	regression analysis of satisfaction scores with changes in volumetric measurements	upto 90 days
Secondary	Volumetric changes of treatment	3-dimensional photography to measure volumetric changes in each treatment	upto 90 days