A Phase 3 interventional study of Volbella or Juvederm Ultra XC filler in Lip Augmentation and Lip Fullness, sponsored by DeNova Research. Completed at 1 site in United States. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-07.
Sponsored by DeNova Research · Phase 3, Interventional, and Treatment
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).
DeNova Research is the lead sponsor of 19 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Hyaluronic acid filler
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.
Time frame: 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.
Time frame: 1 month
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.
Time frame: 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.
Time frame: 1 month
Plan to share: No — Private study
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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DeNova Research