cosmetische verfraaiing met het verbeteren van kwaliteit van leven als doel Cosmetic lip augmentation.
Conditions
Interventions
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 in
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Age 18 years or over. • Female sex. • 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 one to three out of four).
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • History of temporary of permanent filler treatment, or implant, in the lip. • Absolute contra-indications for HA filler treatment of the lip (Lafaille & Bernedetto, 2010; DeBoulle & Heydenrych, 2015). * Active peri-oral infection or inflammation in vicinity of injection site (e.g., acne or herpes) * Tumour in vincinity 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) * History of allergy to gram-positive proteins * History of allergy to 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 • Absolute contra-indications provided by the manufacturers * General infection * Porphyria * Untreated epilepsy * Keloid tendency * Cardiac arrythmia * Severe liver or kidney disease • Relative contra-indication for HA filler treatment of the lip. Fulfilling the DSM 5 diagnostic criteria for Body Dyspmorphic Disorder (APA, 2016). • The product will not be administered in combination with a peeling, laser treatment, or dermabrasion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether superiority can be shown of one or more HA soft tissue filler products over the others in longevity of the absolute lip volume augmentation, as measured by the Lemperle Lip Index from baseline to 3-months follow-up (Lemperle, Anderson, and Knapp 2010). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives include; • To determine whether superiority can be shown of one or more HA soft tissue filler products over the others in safety, as measured by the relative incidence of side effects (as measured by the FACE-Q questionnaire *Recovery Early Symptoms* and *Adverse Effects: Lips*) and adverse events related to the procedure. • To determine whether superiority can be shown of one or more HA soft tissue filler products over the others in absolute lip volume augmentation as measured by the Lip Index from baseline to 3-weeks follow-up. • To determine whether superiority can be shown of one or more HA soft tissue filler products over the others in quality of life and satisfaction with the treatment as measured by validated FACE-Q questionnaire scores (*Decision*, *Outcome*, *Satisfaction with Lips*, *Early Life Impact*, *Social*, *Psychological*) from baseline to 3-months follow-up (Klassen et al. 2015). | — |
Countries
Netherlands
Outcome results
None listed