Prospective Evaluation of Facial Cosmetic Procedures

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-21

Study Completion Date

2024-05-29

Brief Summary

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

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Detailed Description

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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

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Cosmetic Techniques

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Hyaluronic acid

Group Type EXPERIMENTAL

Restylane-L®

Intervention Type DRUG

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

Intervention Type 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).

Restylane Silk®

Intervention Type 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.

Interventions

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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.

Intervention Type 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).

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Hyaluronic acid gel Hyaluronic acid gel Hyaluronic acid gel

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes