Perioral Rejuvenation and Upper Lip Enhancement

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-20

Study Completion Date

2018-07-03

Brief Summary

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To determine if subjects who receive premaxillary injection demonstrate an increase in nasal tip projection and an associated increase in upper lip projection, and vermillion height.

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Detailed Description

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Conditions

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Perioral Rejuvenation Upper Lip Projection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nasal Tip Projection

Group Type EXPERIMENTAL

Restylane® Defyne

Intervention Type DEVICE

hyaluronic acid filler injection

Upper Lip Position

Group Type EXPERIMENTAL

Restylane® Defyne

Intervention Type DEVICE

hyaluronic acid filler injection

Interventions

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Restylane® Defyne

hyaluronic acid filler injection

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 1\. Subjects Age 21 to 70. 2. Subjects who demonstrate signs of perioral aging or poor upper lip projection.

Exclusion Criteria

* 1\. Subjects who plan to undergo peri oral neurotoxin treatments or ablative skin treatments, or have had either of these treatments in the previous 6 months, other injectable filler treatments during the course of the study.

2\. Subjects who are pregnant or nursing. 3. Subjects with a known allergy or sensitivity to any component of the study ingredients.

4\. Any history of rhinoplasty or nasal filler injections. 5. Recent history of upper lip augmentation (surgical and non-surgical) within the last 12 months.

6\. Any history of lip lift or other surgical procedures involving the upper lip.

7\. Any history of chin augmentation (surgical and non-surgical). 8. Any history of orthognathic surgery. 9. Any history of bleeding disorders (iatrogenic or otherwise). 10. Current history of chronic drug or alcohol abuse. 11. Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study product (i.e. immunosuppressive therapy).

12\. Subjects who, in the Investigator's opinion, have a history of poor cooperation, non¬compliance with medical treatment or unreliability.

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes