Ethnic Lip Augmentation With Hyaluronic Acid Filler

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-07-01

Brief Summary

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

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Detailed Description

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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).

Conditions

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Lip Augmentation Lip Fullness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Volbella or Juvederm Ultra XC filler

Intervention Type DRUG

Hyaluronic acid filler

Interventions

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Volbella or Juvederm Ultra XC filler

Hyaluronic acid filler

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes