LipNCT04362891
Four Hyaluronic Acid Fillers for Lip Augmentation
A study testing Cosmetic lip augmentation in people with Lip, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 4 sites in Netherlands.
Trial summary
There is need for evidence-based and reproducible data comparing the safety, longevity and patient satisfaction propensity of the various HA soft tissue filler products. Among cosmetic HA soft tissue filler procedures, especially the lip augmentation has become common. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lip
- What is being tested?
- Cosmetic lip augmentation
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 4 sitesNetherlands
- Study dates
- 5 Jul 2021to 12 Jan 2022
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or over.
- Female sex.
- No history of previous lip augmentation treatment.
- Oral and written informed consent to participate in the study.
- Desire for cosmetic lip augmentation to improve one's physical or mental well-being.
- Actively treatment seeking (patient actively chooses to make an appointment at a Faceland private cosmetic clinic without invitation).
- Small to moderately full lip volume (Merz Lip Scale score 0 - 2 out of 4).
Who cannot join
- Active peri-oral infection in vicinity of injection site
- Tumour in vicinity of injection site
- Active tuberculosis
- Pregnant or breast-feeding
- History of severe hypersensitivity to filler components (sodium hyaluronate preparations or local anesthetics of the -amide type, gram-positive proteins, wasps/bees or the hyaluronidase enzyme)
- Active collagenosis (e.g., active systemic lupus)
Show all 17Show fewer
- Graft vs. host disease
- Active Hashimoto's disease
- Use of thrombolytics or anticoagulants with high bleeding risk
- General infection
- Porphyria
- Untreated epilepsy
- Keloid tendency
- Cardiac arrythmia
- Severe liver or kidney disease
- Fulfilling the DSM-5 diagnostic criteria for Body Dyspmorphic Disorder
- Concurrent laser- peeling- or dermabrasia treatment
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Faceland Almere
Almere Stad, Flevoland, 1314 BM
Faceland Eindhoven
Eindhoven, North Brabant, 5652 XR
Faceland Rotterdam
Rotterdam, South Holland, 3011 HB
Faceland Utrecht
Utrecht, 3565 AC
About this study
Official title: Safety, Longevity and Patient Satisfaction Comparison of Four Hyaluronic Acid Soft Tissue Fillers in Lip Augmentation: Study Protocol for a Randomized Controlled Clinical Trial
There is need for evidence-based and reproducible data comparing the safety, longevity and patient satisfaction propensity of the various HA soft tissue filler products. Among cosmetic HA soft tissue filler procedures, especially the lip augmentation has become common. Therefore, the aim of this study is to determine whether a statistically significant difference can be detected in the safety, longevity and/or patient satisfaction related to four HA soft tissue filler products widely used for cosmetic lip augmentation. Specifically, the aim of this study is to determine whether superiority of one or more product(s) over the others can be detected.
Read the detailed description
Rationale: Currently, hyaluronic acid (HA) soft tissue fillers are widely employed in cosmetic medical practice for facial contouring and rejuvenation. Among these procedures, especially the lip augmentation has become common. To this end various products have become commercially available, however to date no robust evidence is available to support the safety, longevity or patient satisfaction propensity superiority of one product over the others.
Objective: To assess whether superiority in safety, longevity and patient satisfaction propensity can be shown of one of four most frequently used FDA-approved and/or CE marked HA fillers worldwide, used to augment the lip, over the others.
Study design: Multi-center, randomized, controlled, four group, parallel, triple-blind clinical trial of 160 adult participants.
Study population: Consecutive healthy individuals with no history of previous lip treatment and a self-reported wish for lip augmentation, who present at one of the private cosmetic medicine clinics in the Netherlands, will be recruited.
Intervention (if applicable): After giving informed consent, participants will be randomized to receive a protocoled lip augmentation procedure by the injection of either 1 mL of brand A, B, C or D.
Main study parameters/endpoints: The primary outcome measure will be the absolute lip volume augmentation as measured by the Lemperle Lip Index from baseline to 3-months follow-up. Secondary outcomes will include the incidence of serious adverse reactions and side effects related to the procedure, the absolute volume augmentation from baseline to 2-weeks follow-up and self-reported quality of life and satisfaction with aesthetic results from baseline to 2-weeks follow-up as measured by validated FACE-Q questionnaire scores.
- Conditions
- Lip
- Being tested
- Cosmetic lip augmentation
- Keywords
- Hyaluronic Acid, Dermal Fillers, Lip, Safety, Longevity, Quality of Life, Patient Satisfaction
- Medical subject headings
- Lymphoid Interstitial Pneumonia, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmetic lip augmentationProcedure or surgery
The primary study treatment site will be the vermilion (body of the lip); additional areas (vermilion borders, Cupid's bow, philtral columns, and/or oral commissures) will be treated if deemed appropriate by the treating physician. Treatment will be administered through intradermal, subdermal, and/or intramuscular injection within the orbicularis oris muscle. Injection techniques for each area will include linear threading, serial puncture, fanning, and/or cross-hatching. The treating physician will determine the appropriate volume to inject based on clinical experience and the subject's goals for lip augmentation.
| Study group | Role | What they receive |
|---|---|---|
| Juvéderm® | Experimental | Cross-linked hyaluronic acid dermal filler product brand A (1,0 mL at baseline and 0,2 mL touch-up at 2-week follow-up). Receives: Procedure: Cosmetic lip augmentation |
| Restylane® | Experimental | Cross-linked hyaluronic acid dermal filler product brand B (1,0 mL at baseline and 0,2 mL touch-up at 2-week follow-up). Receives: Procedure: Cosmetic lip augmentation |
| Belotero® | Experimental | Cross-linked hyaluronic acid dermal filler product brand C (1,0 mL at baseline and 0,2 mL touch-up at 2-week follow-up). Receives: Procedure: Cosmetic lip augmentation |
| Stylage® | Experimental | Cross-linked hyaluronic acid dermal filler product brand D (1,0 mL at baseline and 0,2 mL touch-up at 2-week follow-up). Receives: Procedure: Cosmetic lip augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longevity of absolute lip volume augmentation
The primary outcome will be the longevity of the absolute lip volume augmentation, as measured by the modified Lemperle Lip Index (vertical height in mm).
Measured: from baseline to 3-months follow-up
Secondary outcomes (4)
Patient satisfaction (lip appraisal)
Patient satisfaction with the treatment as measured by validated FACE-Q questionnaire "Lips" score.
Measured: from baseline to 3-months follow-up
Quality of Life (Social)
Quality of Life as measured by validated FACE-Q questionnaire "Social Function" score.
Measured: baseline to 3-months follow-up
Quality of Life (Psychological)
Quality of Life as measured by validated FACE-Q questionnaire "Psychological Wellbeing" score.
Measured: baseline to 3-months follow-up
Product safety (serious adverse events)
Product safety, as measured by serious adverse events related to the procedure.
Measured: baseline, 2-weeks and 3-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start5 Jul 2021
- Primary completion12 Jan 2022
- Study completion12 Jan 2022
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 LipStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter; triple blind; randomized; parallel; controlled trial with 4 treatment arms (4 different widely used commercially available HA soft tissue fillers with FDA approval status and/or CE-marking for cosmetic facial use).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Faceland Clinics
- Responsible party
- Principal investigator, Prof. dr. J. de Lange, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jan de Lange, MD DDS PhD, Principal investigator, University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362891
- Sponsor's protocol ID
- NL73349.029.20
- Status last verified
- Mar 2022
- First submitted
- 16 Apr 2020
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stojanovic L, Majdic N. Effectiveness and safety of hyaluronic acid fillers used to enhance overall lip fullness: A systematic review of clinical studies. J Cosmet Dermatol. 2019 Apr;18(2):436-443. doi: 10.1111/jocd.12861. Epub 2019 Jan 12.
PubMed 30636365Alam M, Kakar R, Nodzenski M, Ibrahim O, Disphanurat W, Bolotin D, Borovicka JH, Pace N, Alster TS, Arndt KA, Beer KR, Berlin JM, Bernstein LJ, Brightman LA, Butterwick K, Cox SE, Chotzen V, Fabi SG, Fitzpatrick RE, Geronemus RG, Goldman MP, Groff WF, Kaminer MS, Kilmer S, Rohrer TE, Tanzi EL, Silva SK, Yoo SS, Weinkle SH, Strasswimmer J, Poon E, Dover JS. Multicenter prospective cohort study of the incidence of adverse events associated with cosmetic dermatologic procedures: lasers, energy devices, and injectable neurotoxins and fillers. JAMA Dermatol. 2015 Mar;151(3):271-7. doi: 10.1001/jamadermatol.2014.2494.
PubMed 25372511Barone M, Cogliandro A, Cagli B, Persichetti P. FACE-Q Scales for Health-Related Quality of Life, Early Life Impact, Satisfaction with Outcomes, and Decision to Have Treatment: Development and Validation. Plast Reconstr Surg. 2015 Aug;136(2):272e-273e. doi: 10.1097/PRS.0000000000001439. No abstract available.
PubMed 26218401
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Longevity and Patient Satisfaction Comparison of Four Hyaluronic Acid Soft Tissue Fillers in Lip Augmentation: Study Protocol for a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04362891
- Acronym / sponsor ID
- NL73349.029.20
- Conditions
- Lip
- Keywords
- Hyaluronic Acid, Dermal Fillers, Lip, Safety, Longevity, Quality of Life, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Faceland Clinics
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 12 Jan 2022 (actual)
- First posted
- 27 Apr 2020 (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.
There is need for evidence-based and reproducible data comparing the safety, longevity and patient satisfaction propensity of the various HA soft tissue filler products. Among cosmetic HA soft tissue filler procedures, especially the lip augmentation has become common. Therefore, the aim of this study is to determine whether a statistically significant difference can be detected in the safety, longevity and/or patient satisfaction related to four HA soft tissue filler products widely used for cosmetic lip augmentation. Specifically, the aim of this study is to determine whether superiority of one or more product(s) over the others can be detected.
Detailed description
Rationale: Currently, hyaluronic acid (HA) soft tissue fillers are widely employed in cosmetic medical practice for facial contouring and rejuvenation. Among these procedures, especially the lip augmentation has become common. To this end various products have become commercially available, however to date no robust evidence is available to support the safety, longevity or patient satisfaction propensity superiority of one product over the others.
Objective: To assess whether superiority in safety, longevity and patient satisfaction propensity can be shown of one of four most frequently used FDA-approved and/or CE marked HA fillers worldwide, used to augment the lip, over the others.
Study design: Multi-center, randomized, controlled, four group, parallel, triple-blind clinical trial of 160 adult participants.
Study population: Consecutive healthy individuals with no history of previous lip treatment and a self-reported wish for lip augmentation, who present at one of the private cosmetic medicine clinics in the Netherlands, will be recruited.
Intervention (if applicable): After giving informed consent, participants will be randomized to receive a protocoled lip augmentation procedure by the injection of either 1 mL of brand A, B, C or D.
Main study parameters/endpoints: The primary outcome measure will be the absolute lip volume augmentation as measured by the Lemperle Lip Index from baseline to 3-months follow-up. Secondary outcomes will include the incidence of serious adverse reactions and side effects related to the procedure, the absolute volume augmentation from baseline to 2-weeks follow-up and self-reported quality of life and satisfaction with aesthetic results from baseline to 2-weeks follow-up as measured by validated FACE-Q questionnaire scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Multicenter; triple blind; randomized; parallel; controlled trial with 4 treatment arms (4 different widely used commercially available HA soft tissue fillers with FDA approval status and/or CE-marking for cosmetic facial use).
| Arm | Type | Receives |
|---|---|---|
| Juvéderm® | Experimental | Procedure: Cosmetic lip augmentationCross-linked hyaluronic acid dermal filler product brand A (1,0 mL at baseline and 0,2 mL touch-up at 2-week follow-up). |
| Restylane® | Experimental | Procedure: Cosmetic lip augmentationCross-linked hyaluronic acid dermal filler product brand B (1,0 mL at baseline and 0,2 mL touch-up at 2-week follow-up). |
| Belotero® | Experimental | Procedure: Cosmetic lip augmentationCross-linked hyaluronic acid dermal filler product brand C (1,0 mL at baseline and 0,2 mL touch-up at 2-week follow-up). |
| Stylage® | Experimental | Procedure: Cosmetic lip augmentationCross-linked hyaluronic acid dermal filler product brand D (1,0 mL at baseline and 0,2 mL touch-up at 2-week follow-up). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or over.
- Female sex.
- No history of previous lip augmentation treatment.
- Oral and written informed consent to participate in the study.
- Desire for cosmetic lip augmentation to improve one's physical or mental well-being.
Key exclusion criteria (17 listed)
- Active peri-oral infection in vicinity of injection site
- Tumour in vicinity of injection site
- Active tuberculosis
- Pregnant or breast-feeding
- History of severe hypersensitivity to filler components (sodium hyaluronate preparations or local anesthetics of the -amide type, gram-positive proteins, wasps/bees or the hyaluronidase enzyme)
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 |
|---|---|---|
| Cosmetic lip augmentationThe primary study treatment site will be the vermilion (body of the lip); additional areas (vermilion borders, Cupid's bow, philtral columns, and/or oral commissures) will be treated if deemed appropriate by the treating physician. Treatment will be administered through intradermal, subdermal, and/or intramuscular injection within the orbicularis oris muscle. Injection techniques for each area will include linear threading, serial puncture, fanning, and/or cross-hatching. The treating physician will determine the appropriate volume to inject based on clinical experience and the subject's goals for lip augmentation. | Procedure or surgery | Belotero®, Juvéderm®, Restylane®, Stylage® |
Primary outcome
Longevity of absolute lip volume augmentation
Time frame: from baseline to 3-months follow-up
The primary outcome will be the longevity of the absolute lip volume augmentation, as measured by the modified Lemperle Lip Index (vertical height in mm).
4 secondary outcomes
Patient satisfaction (lip appraisal)
Time frame: from baseline to 3-months follow-up
Quality of Life (Social)
Time frame: baseline to 3-months follow-up
Quality of Life (Psychological)
Time frame: baseline to 3-months follow-up
Product safety (serious adverse events)
Time frame: baseline, 2-weeks and 3-months follow-up
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 22 Mar 2022.
- Results publication: PubMed 30636365Stojanovic L, Majdic N. Effectiveness and safety of hyaluronic acid fillers used to enhance overall lip fullness: A systematic review of clinical studies. J Cosmet Dermatol. 2019 Apr;18(2):436-443. doi: 10.1111/jocd.12861. Epub 2019 Jan 12.
- Results publication: PubMed 25372511Alam M, Kakar R, Nodzenski M, Ibrahim O, Disphanurat W, Bolotin D, Borovicka JH, Pace N, Alster TS, Arndt KA, Beer KR, Berlin JM, Bernstein LJ, Brightman LA, Butterwick K, Cox SE, Chotzen V, Fabi SG, Fitzpatrick RE, Geronemus RG, Goldman MP, Groff WF, Kaminer MS, Kilmer S, Rohrer TE, Tanzi EL, Silva SK, Yoo SS, Weinkle SH, Strasswimmer J, Poon E, Dover JS. Multicenter prospective cohort study of the incidence of adverse events associated with cosmetic dermatologic procedures: lasers, energy devices, and injectable neurotoxins and fillers. JAMA Dermatol. 2015 Mar;151(3):271-7. doi: 10.1001/jamadermatol.2014.2494.
- Results publication: PubMed 26218401Barone M, Cogliandro A, Cagli B, Persichetti P. FACE-Q Scales for Health-Related Quality of Life, Early Life Impact, Satisfaction with Outcomes, and Decision to Have Treatment: Development and Validation. Plast Reconstr Surg. 2015 Aug;136(2):272e-273e. doi: 10.1097/PRS.0000000000001439. No abstract available.
- Individual participant dataSharing planned: No
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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.
Jan de Lange, MD DDS PhD principal investigator
University of Amsterdam
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cosmetic lip augmentation in people with Lip, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 4 sites in Netherlands.
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 7 inclusion and 17 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 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. 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.
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?
Longevity of absolute lip volume augmentation (time frame: from baseline to 3-months follow-up). 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 NCT04362891, 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 22 Mar 2022.