Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Four Hyaluronic Acid Fillers for Lip Augmentation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04362891
Recruitment Status : Completed
First Posted : April 27, 2020
Last Update Posted : March 22, 2022
Sponsor:
Collaborator:
Faceland Clinics
Information provided by (Responsible Party):
Prof. dr. J. de Lange, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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).
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 : July 5, 2021
Actual Primary Completion Date : January 12, 2022
Actual Study Completion Date : January 12, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Longevity of absolute lip volume augmentation [ Time Frame: 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 :
  1. Patient satisfaction (lip appraisal) [ Time Frame: from baseline to 3-months follow-up ]
    Patient satisfaction with the treatment as measured by validated FACE-Q questionnaire "Lips" score.

  2. Quality of Life (Social) [ Time Frame: baseline to 3-months follow-up ]
    Quality of Life as measured by validated FACE-Q questionnaire "Social Function" score.

  3. Quality of Life (Psychological) [ Time Frame: baseline to 3-months follow-up ]
    Quality of Life as measured by validated FACE-Q questionnaire "Psychological Wellbeing" score.

  4. Product safety (serious adverse events) [ Time Frame: baseline, 2-weeks and 3-months follow-up ]
    Product safety, as measured by serious adverse events related to the procedure.


Other Outcome Measures:
  1. Effectiveness of absolute lip volume augmentation at week 2 [ Time Frame: from baseline to 2-weeks follow-up ]
    A between-group difference in volume augmentation from baseline to 2-weeks follow-up,

  2. Patient satisfaction (with treatment outcome) [ Time Frame: 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.

  3. Patient satisfaction (with decision) [ Time Frame: 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.

  4. Side-effects (psychological impact of recovery from treatment) [ Time Frame: at 2 weeks and 3 months follow-up ]
    Side-effects, as measured by the FACE-Q questionnaire "Early Life Impact" score.

  5. Side-effects (physical discomfort) [ Time Frame: baseline, 2-weeks and 3-months follow-up ]
    Side-effects, as measured by the FACE-Q questionnaire "Adverse Effects Lips" score.

  6. Side-effects (recovery of side-effects) [ Time Frame: baseline, 2-weeks and 3-months follow-up ]
    Side-effects, as measured by validated FACE-Q questionnaire scores "Recovery Early Symptoms" score.

  7. Absolute lip volume augmentation at week 2 [ Time Frame: from baseline to 2-weeks follow-up ]
    The absolute lip volume augmentation as measured by the Lemperle Lip Index.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04362891


Locations
Layout table for location information
Netherlands
Faceland Almere
Almere, Flevoland, Netherlands, 1314 BM
Faceland Eindhoven
Eindhoven, Noord-Brabant, Netherlands, 5652 XR
Faceland Rotterdam
Rotterdam, Zuid-Holland, Netherlands, 3011 HB
Faceland Utrecht
Utrecht, Netherlands, 3565 AC
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Faceland Clinics
Investigators
Layout table for investigator information
Principal Investigator: Jan de Lange, MD DDS PhD University of Amsterdam
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
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: April 27, 2020    Key Record Dates
Last Update Posted: March 22, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. dr. J. de Lange, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Hyaluronic Acid
Dermal Fillers
Lip
Safety
 Longevity
Quality of Life
Patient Satisfaction