Four Hyaluronic Acid Fillers for Lip Augmentation

Lip Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04362891
• Other study ID #: NL73349.029.20
• Status: Completed
• Phase: N/A
• Start date: July 5, 2021
• Est. completion date: January 12, 2022

Study information

• Verified date: March 2022
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: January 12, 2022
• Est. primary completion date: January 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lip

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Faceland Almere	Almere	Flevoland
Netherlands	Faceland Eindhoven	Eindhoven	Noord-Brabant
Netherlands	Faceland Rotterdam	Rotterdam	Zuid-Holland
Netherlands	Faceland Utrecht	Utrecht

Sponsors (2)

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

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

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, Kam — View Citation

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. do — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effectiveness of absolute lip volume augmentation at week 2	A between-group difference in volume augmentation from baseline to 2-weeks follow-up,	from baseline to 2-weeks follow-up
Other	Patient satisfaction (with treatment outcome)	Patient satisfaction with the treatment as measured by validated FACE-Q questionnaire scores "Satisfaction with Outcome of Treatment" score.	at 2 weeks and 3 months follow-up
Other	Patient satisfaction (with decision)	Patient satisfaction with the treatment as measured by validated FACE-Q questionnaire "Satisfaction with Decision to Have Treatment" score.	at 2 weeks and 3 months follow-up
Other	Side-effects (psychological impact of recovery from treatment)	Side-effects, as measured by the FACE-Q questionnaire "Early Life Impact" score.	at 2 weeks and 3 months follow-up
Other	Side-effects (physical discomfort)	Side-effects, as measured by the FACE-Q questionnaire "Adverse Effects Lips" score.	baseline, 2-weeks and 3-months follow-up
Other	Side-effects (recovery of side-effects)	Side-effects, as measured by validated FACE-Q questionnaire scores "Recovery Early Symptoms" score.	baseline, 2-weeks and 3-months follow-up
Other	Absolute lip volume augmentation at week 2	The absolute lip volume augmentation as measured by the Lemperle Lip Index.	from baseline to 2-weeks follow-up
Primary	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	Patient satisfaction (lip appraisal)	Patient satisfaction with the treatment as measured by validated FACE-Q questionnaire "Lips" score.	from baseline to 3-months follow-up
Secondary	Quality of Life (Social)	Quality of Life as measured by validated FACE-Q questionnaire "Social Function" score.	baseline to 3-months follow-up
Secondary	Quality of Life (Psychological)	Quality of Life as measured by validated FACE-Q questionnaire "Psychological Wellbeing" score.	baseline to 3-months follow-up
Secondary	Product safety (serious adverse events)	Product safety, as measured by serious adverse events related to the procedure.	baseline, 2-weeks and 3-months follow-up