Skip to main content
OpenTrials
Completed

NCT Number: NCT03460158

Prospective Evaluation of Facial Cosmetic Procedures

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cosmetic Techniques

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Restylane-L®

Drug

Restylane-L® for the indication for mid-to-deep dermal implantation for moderate to severe facial wrinkles and folds, such as nasolabial folds.

Other names: Hyaluronic acid gel

Restylane-L® Lyft

Drug

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).

Other names: Hyaluronic acid gel

Restylane Silk®

Drug

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.

Other names: Hyaluronic acid gel

Primary outcomes

  1. Patient Satisfaction With Validated FACE-Q Aesthetics Survey

    Time frame: 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 outcomes

  1. Correlate Patient Satisfaction With Volumetric Measurements

    Time frame: 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.

  2. Volumetric Changes of Treatment

    Time frame: immediately post injection, 2 weeks, 4 weeks, and 12 weeks

    3-dimensional photography to measure volumetric changes in each treatment

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Galderma R&D

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 9, 2018
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.