Phase 4 N=101 Treatment

Prospective Evaluation of Facial Cosmetic Procedures

Cosmetic Techniques

Bottom Line

View on ClinicalTrials.gov: NCT03460158 ↗

Enrolled (actual)

101

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcome: Primary: Patient Satisfaction With Validated FACE-Q Aesthetics Survey — 28.0; 24.0; 36.0; 36.0 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Restylane-L® (Drug); Restylane-L® Lyft (Drug); Restylane Silk® (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: Female
Sponsor: University of Pennsylvania
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Patient Satisfaction With Validated FACE-Q Aesthetics Survey	28.0; 24.0; 36.0; 36.0; 23.5; 32.0	—
SECONDARY Correlate Patient Satisfaction With Volumetric Measurements	0.0226; -0.1796; -0.3692	0.8822
SECONDARY Volumetric Changes of Treatment	9.86; 8.80; 7.63; 5.79	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03460158). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.