Four Hyaluronic Acid Fillers for Lip Augmentation

NCT ID: NCT04362891

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-05
• Study Completion Date: 2022-01-12

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.

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.

Conditions

Lip

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Cosmetic lip augmentation

Intervention Type: 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.

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).

Group Type: EXPERIMENTAL

Cosmetic lip augmentation

Intervention Type: 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®

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).

Group Type: EXPERIMENTAL

Cosmetic lip augmentation

Intervention Type: 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.

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).

Group Type: EXPERIMENTAL

Cosmetic lip augmentation

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Faceland Clinics

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Prof. dr. J. de Lange

Prof. dr. J. de Lange, Head of OMFS Surgery, Principal Investigator, Clinical Professor, at AUMC - location AMC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan de Lange, MD DDS PhD

Role: PRINCIPAL_INVESTIGATOR

University of Amsterdam

Locations

Faceland Almere

Almere Stad, Flevoland, Netherlands

Faceland Eindhoven

Eindhoven, North Brabant, Netherlands

Faceland Rotterdam

Rotterdam, South Holland, Netherlands

Faceland Utrecht

Utrecht, , Netherlands

Countries

Netherlands

References

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.

Reference Type: RESULT

PMID: 30636365 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25372511 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26218401 (View on PubMed)

Other Identifiers

NL73349.029.20

Identifier Type: -

Identifier Source: org_study_id