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Completed

NCT Number: NCT05730543

Ethnic Lip Augmentation With Hyaluronic Acid Filler

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

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Key information

Conditions

Lip Augmentation Lip Fullness

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

DeNova Research

Chicago, Illinois, 60611, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Volbella or Juvederm Ultra XC filler

Drug

Hyaluronic acid filler

Primary outcomes

  1. Lip size

    Time frame: 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.

  2. Satisfaction level

    Time frame: 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 outcomes

  1. LFS by age group

    Time frame: 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.

  2. Improvement level

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

DeNova Research

Other

Registry information

Official study title

Ethnic Lip Augmentation With Hyaluronic Acid Filler: Utilization of a Validated Lip Fullness Scale and Determining Pre Injection Lips Size Preference and Post Injection Patient Satisfaction

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 16, 2023
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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