Four Hyaluronic Acid Fillers for Lip Augmentation

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)

Overall Status

Completed

CT.gov ID

NCT04362891

Collaborator

Faceland Clinics (Other)

143

Enrollment

Locations

Arms

6.3

Actual Duration (Months)

35.8

Patients Per Site

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lip	Procedure: Cosmetic lip augmentation	N/A

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

Study Type:

Interventional

Actual Enrollment :

143 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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).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 (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Participant, Care Provider, Investigator, Outcome Assessor

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 5, 2021

Actual Primary Completion Date :

Jan 12, 2022

Actual Study Completion Date :

Jan 12, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Juvéderm® 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).	Procedure: Cosmetic 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.
Experimental: Restylane® 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).	Procedure: Cosmetic 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.
Experimental: Belotero® 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).	Procedure: Cosmetic 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.
Experimental: Stylage® 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).	Procedure: Cosmetic 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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Outcome Measures

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,
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faceland Almere	Almere	Flevoland	Netherlands	1314 BM
2	Faceland Eindhoven	Eindhoven	Noord-Brabant	Netherlands	5652 XR
3	Faceland Rotterdam	Rotterdam	Zuid-Holland	Netherlands	3011 HB
4	Faceland Utrecht	Utrecht		Netherlands	3565 AC

Sponsors and Collaborators

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Faceland Clinics

Investigators

Principal Investigator: Jan de Lange, MD DDS PhD, University of Amsterdam

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. dr. J. de Lange, Prof. dr. J. de Lange, Head of OMFS Surgery, Principal Investigator, Clinical Professor, at AUMC - location AMC, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

ClinicalTrials.gov Identifier:

NCT04362891

Other Study ID Numbers:

NL73349.029.20

First Posted:

Apr 27, 2020

Last Update Posted:

Mar 22, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Prof. dr. J. de Lange, Prof. dr. J. de Lange, Head of OMFS Surgery, Principal Investigator, Clinical Professor, at AUMC - location AMC, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Results

No Results Posted as of Mar 22, 2022