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| Name | Class |
|---|---|
| Faceland Clinics | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cosmetic lip augmentation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | from baseline to 3-months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction (lip appraisal) | Patient satisfaction with the treatment as measured by validated FACE-Q questionnaire "Lips" score. | from baseline to 3-months follow-up |
| Quality of Life (Social) |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of absolute lip volume augmentation at week 2 | A between-group difference in volume augmentation from baseline to 2-weeks follow-up, | from baseline to 2-weeks follow-up |
| Patient satisfaction (with treatment outcome) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan de Lange, MD DDS PhD | University of Amsterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faceland Almere | Almere Stad | Flevoland | 1314 BM | Netherlands | ||
| Faceland Eindhoven |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30636365 | Result | 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. | |
| 25372511 | Result | Alam 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. |
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| ID | Term |
|---|---|
| C562489 | Lymphoid Interstitial Pneumonia |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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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).
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Participant, Care Provider, Investigator, Outcome Assessor
|
Quality of Life as measured by validated FACE-Q questionnaire "Social Function" score.
| baseline to 3-months follow-up |
| Quality of Life (Psychological) | Quality of Life as measured by validated FACE-Q questionnaire "Psychological Wellbeing" score. | baseline to 3-months follow-up |
| Product safety (serious adverse events) | Product safety, as measured by serious adverse events related to the procedure. | baseline, 2-weeks and 3-months follow-up |
Patient satisfaction with the treatment as measured by validated FACE-Q questionnaire scores "Satisfaction with Outcome of Treatment" score.
| at 2 weeks and 3 months follow-up |
| Patient satisfaction (with decision) | Patient satisfaction with the treatment as measured by validated FACE-Q questionnaire "Satisfaction with Decision to Have Treatment" score. | at 2 weeks and 3 months follow-up |
| Side-effects (psychological impact of recovery from treatment) | Side-effects, as measured by the FACE-Q questionnaire "Early Life Impact" score. | at 2 weeks and 3 months follow-up |
| Side-effects (physical discomfort) | Side-effects, as measured by the FACE-Q questionnaire "Adverse Effects Lips" score. | baseline, 2-weeks and 3-months follow-up |
| Side-effects (recovery of side-effects) | Side-effects, as measured by validated FACE-Q questionnaire scores "Recovery Early Symptoms" score. | baseline, 2-weeks and 3-months follow-up |
| Absolute lip volume augmentation at week 2 | The absolute lip volume augmentation as measured by the Lemperle Lip Index. | from baseline to 2-weeks follow-up |
| Eindhoven |
| North Brabant |
| 5652 XR |
| Netherlands |
| Faceland Rotterdam | Rotterdam | South Holland | 3011 HB | Netherlands |
| Faceland Utrecht | Utrecht | 3565 AC | Netherlands |
| 26218401 | Result | Barone 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. |