Status:
COMPLETED
Perioral Rejuvenation and Upper Lip Enhancement
Lead Sponsor:
DeNova Research
Conditions:
Perioral Rejuvenation
Upper Lip Projection
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 1\. Subjects Age 21 to 70. 2. Subjects who demonstrate signs of perioral aging or poor upper lip projection.
Exclusion
- 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.
Key Trial Info
Start Date :
November 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03273543
Start Date
November 20 2017
End Date
July 3 2018
Last Update
October 8 2020
Active Locations (1)
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1
DeNova Research
Chicago, Illinois, United States, 60611