Ethnic Lip Augmentation With Hyaluronic Acid Filler

DeNova Research

Status and phase: Completed; Phase 3

Conditions: Lip Augmentation; Lip Fullness

Treatments: Drug: Volbella or Juvederm Ultra XC filler

Study type: Interventional

Funder types: Other

Identifiers

NCT05730543

LIPS-DAYAN-22

Details and patient eligibility

About

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

Full description

Using the revised Allergan Lip Fullness Scale (LFS) to improve post injection patient satisfaction in women with Fitzpatrick skin type (FPST) 5 and 6 (examples: Hispanic, African descendants, Indigenous Australians).

Enrollment: 20 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Females below the age of 21
2. Male patients
3. Subjects with LFS 5
4. Fitzpatrick skin Type 1-4
5. Subjects who have had previous lip filler, fat injections or other surgical lip augmentation in the last 12 months
6. Subjects who are pregnant or nursing
7. Subjects with a known allergy or sensitivity to any component of the study ingredients.
8. 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.
9. 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)
10. 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
11. Subjects with active inflammation or infection in the area of treatment

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Volbella or Juvederm Ultra XC filler

Experimental group

Description:

Injection will not exceed a total of 4 cc of hyaluronic acid filler for combined treatment sessions (initial treatment + possible touch up treatment session).

Treatment:

Drug: Volbella or Juvederm Ultra XC filler