Lip AugmentationPhase 3NCT05730543
Ethnic Lip Augmentation With Hyaluronic Acid Filler
A Phase 3 study testing Volbella or Juvederm Ultra XC filler in people with Lip Augmentation and Lip Fullness, run by DeNova Research at 1 site in United States.
Trial summary
Lip augmentation using hyaluronic acid filler in females with Fitzpatrick skin type V-VI Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lip Augmentation, Lip Fullness
- What is being tested?
- Volbella or Juvederm Ultra XC filler
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 1 Jul 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
Lip augmentation using hyaluronic acid filler in females with Fitzpatrick skin type V-VI
Read the detailed description
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
- Lip Augmentation, Lip Fullness
- Being tested
- Volbella or Juvederm Ultra XC filler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volbella or Juvederm Ultra XC fillerDrug
Hyaluronic acid filler
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Volbella or Juvederm Ultra XC filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 month
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start1 Nov 2022
- Primary completion21 Apr 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lip AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- DeNova Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730543
- Sponsor's protocol ID
- LIPS-DAYAN-22
- Status last verified
- Sep 2023
- First submitted
- 1 Dec 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Private study
Publications
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.
PubMed 30059389Werschler 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.
PubMed 25805282Burgess 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.
PubMed 26441107
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05730543
- Acronym / sponsor ID
- LIPS-DAYAN-22
- Conditions
- Lip Augmentation, Lip Fullness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- DeNova ResearchUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lip augmentation using hyaluronic acid filler in females with Fitzpatrick skin type V-VI
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volbella or Juvederm Ultra XC filler | Experimental | Drug: Volbella or Juvederm Ultra XC fillerInjection will not exceed a total of 4 cc of hyaluronic acid filler for combined treatment sessions (initial treatment + possible touch up treatment session). |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volbella or Juvederm Ultra XC fillerHyaluronic acid filler | Drug | Volbella or Juvederm Ultra XC filler |
Primary outcome
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.
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.
2 secondary outcomes
LFS by age group
Time frame: 1 month
Improvement level
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Results publication: PubMed 30059389Dayan 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.
- Results publication: PubMed 25805282Werschler 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.
- Results publication: PubMed 26441107Burgess 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.
- Individual participant dataSharing planned: No. Private study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Volbella or Juvederm Ultra XC filler in people with Lip Augmentation and Lip Fullness, run by DeNova Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lip size (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05730543, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.