Status:
COMPLETED
Four Hyaluronic Acid Fillers for Lip Augmentation
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Faceland Clinics
Conditions:
Lip
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ...
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 augme...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2022
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT04362891
Start Date
July 5 2021
End Date
January 12 2022
Last Update
March 22 2022
Active Locations (4)
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1
Faceland Almere
Almere Stad, Flevoland, Netherlands, 1314 BM
2
Faceland Eindhoven
Eindhoven, North Brabant, Netherlands, 5652 XR
3
Faceland Rotterdam
Rotterdam, South Holland, Netherlands, 3011 HB
4
Faceland Utrecht
Utrecht, Netherlands, 3565 AC