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Perioral Rejuvenation and Upper Lip Enhancement

D

DeNova Research

Status

Completed

Conditions

Upper Lip Projection
Perioral Rejuvenation

Treatments

Device: Restylane® Defyne

Study type

Interventional

Funder types

Other

Identifiers

NCT03273543
REST-DEF-2017

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

21 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

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

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

    5. 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).

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Nasal Tip Projection
Experimental group
Treatment:
Device: Restylane® Defyne
Upper Lip Position
Experimental group
Treatment:
Device: Restylane® Defyne

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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