Lip
Conditions
Keywords
Hyaluronic Acid, Dermal Fillers, Lip, Safety, Longevity, Quality of Life, Patient Satisfaction
Brief 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. 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.
Interventions
PROCEDURECosmetic lip augmentation
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.
Sponsors
Faceland Clinics
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participant, Care Provider, Investigator, Outcome Assessor
Intervention 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).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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).
Exclusion criteria
* 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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Longevity of absolute lip volume augmentation | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction (lip appraisal) | from baseline to 3-months follow-up | Patient satisfaction with the treatment as measured by validated FACE-Q questionnaire Lips score. |
| Quality of Life (Social) | baseline to 3-months follow-up | Quality of Life as measured by validated FACE-Q questionnaire Social Function score. |
| Quality of Life (Psychological) | baseline to 3-months follow-up | Quality of Life as measured by validated FACE-Q questionnaire Psychological Wellbeing score. |
| Product safety (serious adverse events) | baseline, 2-weeks and 3-months follow-up | Product safety, as measured by serious adverse events related to the procedure. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Side-effects (recovery of side-effects) | baseline, 2-weeks and 3-months follow-up | Side-effects, as measured by validated FACE-Q questionnaire scores Recovery Early Symptoms score. |
| Effectiveness of absolute lip volume augmentation at week 2 | from baseline to 2-weeks follow-up | A between-group difference in volume augmentation from baseline to 2-weeks follow-up, |
| Absolute lip volume augmentation at week 2 | from baseline to 2-weeks follow-up | The absolute lip volume augmentation as measured by the Lemperle Lip Index. |
| Patient satisfaction (with treatment outcome) | at 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. |
| Patient satisfaction (with decision) | at 2 weeks and 3 months follow-up | Patient satisfaction with the treatment as measured by validated FACE-Q questionnaire Satisfaction with Decision to Have Treatment score. |
| Side-effects (psychological impact of recovery from treatment) | at 2 weeks and 3 months follow-up | Side-effects, as measured by the FACE-Q questionnaire Early Life Impact score. |
| Side-effects (physical discomfort) | baseline, 2-weeks and 3-months follow-up | Side-effects, as measured by the FACE-Q questionnaire Adverse Effects Lips score. |
Countries
Netherlands
Outcome results
None listed