Four Hyaluronic Acid Fillers for Lip Augmentation

NCT04362891 | Completed DMC

• 1 other identifier: NL73349.029.20
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 4

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.

Conditions

Lip

Keywords

Hyaluronic Acid; Dermal Fillers; Lip; Safety; Longevity; Quality of Life; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• Longevity of absolute lip volume augmentation

  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).

  from baseline to 3-months follow-up

Secondary Outcomes (4)

• Patient satisfaction (lip appraisal)

  from baseline to 3-months follow-up

• Quality of Life (Social)

  baseline to 3-months follow-up

• Quality of Life (Psychological)

  baseline to 3-months follow-up

• Product safety (serious adverse events)

  baseline, 2-weeks and 3-months follow-up

Other Outcomes (7)

• Effectiveness of absolute lip volume augmentation at week 2

  from baseline to 2-weeks follow-up

• Patient satisfaction (with treatment outcome)

  at 2 weeks and 3 months follow-up

• Patient satisfaction (with decision)

  at 2 weeks and 3 months follow-up

Study Arms (4)

Juvéderm®

EXPERIMENTAL

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

Restylane®

EXPERIMENTAL

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

Belotero®

EXPERIMENTAL

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

Stylage®

EXPERIMENTAL

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

Interventions

Cosmetic lip augmentation PROCEDURE

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.

Belotero®; Juvéderm®; Restylane®; Stylage®

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Faceland Clinics: collaborator

Study Sites (4)

Faceland Almere

Almere Stad, Flevoland, 1314 BM, Netherlands

Location

Faceland Eindhoven

Eindhoven, North Brabant, 5652 XR, Netherlands

Location

Faceland Rotterdam

Rotterdam, South Holland, 3011 HB, Netherlands

Location

Faceland Utrecht

Utrecht, 3565 AC, Netherlands

Location

Related Publications (3)

• Stojanovic L, Majdic N. Effectiveness and safety of hyaluronic acid fillers used to enhance overall lip fullness: A systematic review of clinical studies. J Cosmet Dermatol. 2019 Apr;18(2):436-443. doi: 10.1111/jocd.12861. Epub 2019 Jan 12.

  PMID: 30636365 RESULT

• Alam M, Kakar R, Nodzenski M, Ibrahim O, Disphanurat W, Bolotin D, Borovicka JH, Pace N, Alster TS, Arndt KA, Beer KR, Berlin JM, Bernstein LJ, Brightman LA, Butterwick K, Cox SE, Chotzen V, Fabi SG, Fitzpatrick RE, Geronemus RG, Goldman MP, Groff WF, Kaminer MS, Kilmer S, Rohrer TE, Tanzi EL, Silva SK, Yoo SS, Weinkle SH, Strasswimmer J, Poon E, Dover JS. Multicenter prospective cohort study of the incidence of adverse events associated with cosmetic dermatologic procedures: lasers, energy devices, and injectable neurotoxins and fillers. JAMA Dermatol. 2015 Mar;151(3):271-7. doi: 10.1001/jamadermatol.2014.2494.

  PMID: 25372511 RESULT

• Barone M, Cogliandro A, Cagli B, Persichetti P. FACE-Q Scales for Health-Related Quality of Life, Early Life Impact, Satisfaction with Outcomes, and Decision to Have Treatment: Development and Validation. Plast Reconstr Surg. 2015 Aug;136(2):272e-273e. doi: 10.1097/PRS.0000000000001439. No abstract available.

  PMID: 26218401 RESULT

MeSH Terms

Conditions

Lymphoid Interstitial Pneumonia; Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jan de Lange, MD DDS PhD

  University of Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant, Care Provider, Investigator, Outcome Assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. J. de Lange, Head of OMFS Surgery, Principal Investigator, Clinical Professor, at AUMC - location AMC

Model Details: 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).

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 27, 2020
• Study Start: July 5, 2021
• Primary Completion: January 12, 2022
• Study Completion: January 12, 2022
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (4)