Ethnic Lip Augmentation With Hyaluronic Acid Filler

Phase 3

Completed

• Conditions: Lip Augmentation; Lip Fullness
• Interventions: Drug: Volbella or Juvederm Ultra XC filler

• Registration Number: NCT05730543
• Lead Sponsor: DeNova Research

Brief Summary

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

Detailed 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).

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-16
• Primary Completion: 2023-04-21
• Study Completion: 2023-07-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Volbella or Juvederm Ultra XC filler	Volbella or Juvederm Ultra XC filler	Injection will not exceed a total of 4 cc of hyaluronic acid filler for combined treatment sessions (initial treatment + possible touch up treatment session).

Primary Outcome Measures

Name	Time	Method
Lip size	1 month	The size of lip most desired based on the LFS scale. The possible choices are: 1) Minimal: flat or nearly flat contour, minimal red lip show. 2) Mild: some red lip show, no lower lip pout. 3) Moderate: Moderate red lip show with slight lower lip pout. 4) Marked: significant red lip show and lower lip pout, upper lip with moderate pout. 5) Very Marked: very significant red lip show, significant upper and lower lip pout.
Satisfaction level	1 month	Satisfaction levels relative to baseline via the FACE-Q questionnaire. The questionnaire asks the following questions: 1) The shape of your lower lip? 2) How well your lips suit your face? 3) How nice your lips look when you smile. 4) How full your lower lip looks? 5) The style of your lips (e.g. pouty, natural)? 6) The shape of your upper lip? 7) How turned up your upper lip (cupids bow) looks? 8) The size of your lips? 9) How the outer corners of your lips look when your face is relaxed (still)? 10) How full your lips look? The possible choices for each question are as follows: very dissatisfied (1), somewhat dissatisfied (2), somewhat satisfied (3), very satisfied (4). Responses of very satisfied signify a more positive outcome. Overall scores closer to 40 signify a more favorable satisfaction level.

Secondary Outcome Measures

Name	Time	Method
Improvement level	1 month	Subjects will determine which LFS scale category they would like to be and then based upon final visit they will rate themselves again as to where they actually fall on the scale. Investigator will do the same but only at final visit.
LFS by age group	1 month	LFS preference by age group (21-40 years old vs. 41+ years old). The size of lip most desired based on the LFS scale. The possible choices are: 1) Minimal: flat or nearly flat contour, minimal red lip show. 2) Mild: some red lip show, no lower lip pout. 3) Moderate: Moderate red lip show with slight lower lip pout. 4) Marked: significant red lip show and lower lip pout, upper lip with moderate pout. 5) Very Marked: very significant red lip show, significant upper and lower lip pout.

Trial Locations

Locations (1)

DeNova Research; 🇺🇸 Chicago, Illinois, United States