Ethnic Lip Augmentation With Hyaluronic Acid Filler

Completed · Phase 3

Conditions studied: Lip Augmentation, Lip Fullness

In brief

Lip augmentation using hyaluronic acid filler in females with Fitzpatrick skin type V-VI

Key facts

Study ID

NCT05730543

Run by

DeNova Research

People needed

20

Starts

2022-11-01

Expected to finish

2023-07-01

Last updated by the study team

2023-09-07

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Females age 21 and above, with FPST 5 or 6, undergoing lip filler augmentation
• Subjects will be required not to have had previous lip filler, fat injections, or other lip treatments in the last 12 months.
• Subjects that understand the purpose and aspects of the study, freely sign the informed consent, complete the required treatment and follow up protocol.

You may not qualify if…

• Females below the age of 21
• Male patients
• Subjects with LFS 5
• Fitzpatrick skin Type 1-4
• Subjects who have had previous lip filler, fat injections or other surgical lip augmentation in the last 12 months
• Subjects who are pregnant or nursing
• Subjects with a known allergy or sensitivity to any component of the study ingredients.
• Subjects that do not understand the purpose and aspects of the study, do not sign the consent, and do not complete the required treatment and follow up visit will also be excluded.
• Subjects with a history of bleeding disorders (Vitamin K deficiency, liver disease, renal disease, iatrogenic or otherwise). This includes persons who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks (such as Coumadin, Plavix, heparin analogues)
• Subjects should not be taking aspirin, nonsteroidal anti-inflammatory medications, St. John's Wort, or high doses of Vitamin E supplements within 7 days prior to the start of the study
• Subjects with active inflammation or infection in the area of treatment

Where it is running

• DeNova Research — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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