Ethnic Lip Augmentation With Hyaluronic Acid Filler

NCT05730543 | Completed Phase 3 FDA Drug

• 1 other identifier: LIPS-DAYAN-22
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lip Augmentation; Lip Fullness

Outcome Measures

Primary Outcomes (2)

• Lip size

  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.

  1 month

• Satisfaction level

  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.

  1 month

Secondary Outcomes (2)

• LFS by age group

  1 month

• Improvement level

  1 month

Study Arms (1)

Volbella or Juvederm Ultra XC filler

EXPERIMENTAL

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

Drug: Volbella or Juvederm Ultra XC filler

Interventions

Volbella or Juvederm Ultra XC filler DRUG

Hyaluronic acid filler

Volbella or Juvederm Ultra XC filler

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• DeNova Research: lead

Study Sites (1)

DeNova Research

Chicago, Illinois, 60611, United States

Location

Related Publications (3)

• Dayan SH, Bacos JT, Gandhi ND, Ho TT, Kalbag A. Assessment of the Impact of Perioral Rejuvenation With Hyaluronic Acid Filler on Projected First Impressions and Mood Perceptions. Dermatol Surg. 2019 Jan;45(1):99-107. doi: 10.1097/DSS.0000000000001613.

  PMID: 30059389 RESULT

• Werschler WP, Fagien S, Thomas J, Paradkar-Mitragotri D, Rotunda A, Beddingfield FC 3rd. Development and validation of a photographic scale for assessment of lip fullness. Aesthet Surg J. 2015 Mar;35(3):294-307. doi: 10.1093/asj/sju025.

  PMID: 25805282 RESULT

• Burgess C, Awosika O. Ethnic and Gender Considerations in the Use of Facial Injectables: African-American Patients. Plast Reconstr Surg. 2015 Nov;136(5 Suppl):28S-31S. doi: 10.1097/PRS.0000000000001813.

  PMID: 26441107 RESULT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: February 16, 2023
• Study Start: November 1, 2022
• Primary Completion: April 21, 2023
• Study Completion: July 1, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)