Clinical trial NCT04362891: Four Hyaluronic Acid Fillers for Lip Augmentation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lip
Keywords: Hyaluronic Acid
Dermal Fillers
Lip
Safety
Longevity
Quality of Life
Patient Satisfaction
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Faceland Clinics
First posted: 2020-04-27
Enrollment: 143
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Longevity of absolute lip volume augmentation
timeFrame: from baseline to 3-months follow-up
Secondary outcomes:
measure: Patient satisfaction (lip appraisal)
timeFrame: from baseline to 3-months follow-up
measure: Quality of Life (Social)
timeFrame: baseline to 3-months follow-up
measure: Quality of Life (Psychological)
timeFrame: baseline to 3-months follow-up
measure: Product safety (serious adverse events)
timeFrame: baseline, 2-weeks and 3-months follow-up
Other outcomes:
measure: Effectiveness of absolute lip volume augmentation at week 2
timeFrame: from baseline to 2-weeks follow-up
measure: Patient satisfaction (with treatment outcome)
timeFrame: at 2 weeks and 3 months follow-up
measure: Patient satisfaction (with decision)
timeFrame: at 2 weeks and 3 months follow-up
measure: Side-effects (psychological impact of recovery from treatment)
timeFrame: at 2 weeks and 3 months follow-up
measure: Side-effects (physical discomfort)
timeFrame: baseline, 2-weeks and 3-months follow-up
measure: Side-effects (recovery of side-effects)
timeFrame: baseline, 2-weeks and 3-months follow-up
measure: Absolute lip volume augmentation at week 2
timeFrame: from baseline to 2-weeks follow-up
Locations:
city: Almere
country: Netherlands
facility: Faceland Almere
state: Flevoland
city: Eindhoven
country: Netherlands
facility: Faceland Eindhoven
state: Noord-Brabant
city: Rotterdam
country: Netherlands
facility: Faceland Rotterdam
state: Zuid-Holland
city: Utrecht
country: Netherlands
facility: Faceland Utrecht
Study officials:
affiliation: University of Amsterdam
name: Jan de Lange, MD DDS PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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. doi: 10.1097/PRS.0000000000001439. No abstract available.