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Lip augmentation using hyaluronic acid filler in females with Fitzpatrick skin type V-VI
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volbella or Juvederm Ultra XC filler | Drug | Hyaluronic acid filler |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| LFS by age group | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DeNova Research | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30059389 | Result | 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. | |
| 25805282 | 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. |
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Private study
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| 1 month |
| Improvement level | 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. | 1 month |
| 26441107 | 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. |