Clinical trial NCT04917588: Study to Evaluate the Effectiveness, Safety and Long Term Safety of Saypha® FILLER Lidocaine for Lip Augmentation
Official title: A Prospective, Open-label, Multicentre, Randomized Study to Evaluate the Effectiveness, Safety and Long Term Safety of Saypha® FILLER Lidocaine for Lip Augmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abnormal Lip
Keywords: Moderate to Severe Lip Volume Deficit
Lead sponsor: Croma-Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2021-06-08
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, open-label, multicentre, randomized study conducted to evaluate the effectiveness, safety and long-term safety of Saypha® FILLER Lidocaine for lip augmentation.

Detailed description: Following informed consent and screening, eligible subjects with moderate to severe deficiency of lip volume will be randomized to receive Saypha® FILLER Lidocaine from 1 of 2 manufacturing sites. The device will be injected into the submucosa of the lips, and subjects will return for follow-up assessments at Week 3, 6, 26, 52 and optional at Week 76 after the treatment.

A Touch-up treatment may be done at Week 3, if deemed appropriate by the investigator. The performance of the investigational device will be evaluated by the investigator by assessing severity using the LFS, Lip Fullness Scale, at Week 6, 26, 52 after the treatment and optional at Week 76 and in comparison to Day 0. The upper and lower lip will be graded separately.

Telephone visits will be performed approximately 24 hours post-administration to monitor possible adverse events. In case any adverse events are reported during the telephone visits an unscheduled visit should be performed.

Eligibility criteria: Inclusion Criteria:

1. Adult female or male subjects 18 years of age at Screening/Baseline visit (Visit 1)
2. Presence of approximately symmetrical "very thin" lips (minimal red lip shows) to "moderately thick" lips (moderate red lip shows) as assessed with the LFS (severity grade of 1 to 3 on both lips) as determined by the investigator at Visit 1
3. For females of childbearing potential only: negative urine pregnancy test at Visit 1, and must agree to use an highly effective method of contraception for the duration of the clinical investigation
4. Healthy skin in the treatment area and free of diseases that could interfere in evaluation of treatment
5. Willingness to abstain from any cosmetic or surgical procedures in the treatment area for the duration of the clinical investigation
6. Willingness to take part in this clinical investigation documented by a personally signed/dated informed consent.

Exclusion Criteria:

1. Pregnancy, lactation, planned pregnancy or unwillingness to use contraception at any time during the study (for women of child-bearing potential only)
2. History of mental disorders or emotional instability
3. History of allergic reaction or hypersensitivity to hyaluronic acid, lidocaine or any amide-based anaesthetic
4. Prior surgery, scars or tattoo to the upper or lower lip or lip line; surgery and tattooing are prohibited until end of clinical investigation
5. Tooth gap, overbite, beard longer three-day beard, or excessive facial hair that could interfere in evaluation of treatment as judged by the investigator
6. Presence of any abnormal lip structure, such as a scar or lump or severe lip asymmetry, as judged by the investigator
7. Previous tissue augmenting therapy in the lip area (including lips, oral commissures, nasolabial folds, marionette and perioral lines) with HA or collagen filler, or laser treatment, chemical peeling, dermabrasion or mesotherapy within 12 months before Visit 1 and until end of clinical investigation
8. Previous permanent implant or treatment with non-HA or non-collagen filler in the lip area (including lips, oral commissures, nasolabial folds, marionette and perioral lines) and until end of the investigation
9. Previous toxin treatment in the lip area (including lips, oral commissures, nasolabial folds, marionette and perioral lines) within 9 months before Visit 1 and until end of clinical investigation
10. Presence of cutaneous lesions, inflammatory and/or infectious processes (e.g. acne, herpes, etc.) or proliferative lesions in the treatment area
11. Known human immune deficiency virus-positive individuals
12. History of allergies against aesthetic filling products and recurrent (3 times a year) herpes simplex in the treated area
13. Tendency to hypertrophic scars, keloid formation and/or pigmentation disorders
14. History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy
15. Uncontrolled systemic diseases (such as diabetes mellitus)
16. Use of anticoagulant, antiplatelet or thrombolytic medication (e.g. acetylsalicylic acid) from 10 days pre- to three days post IMD injections
17. Planned dental/oral surgery or modification (bridge-work, implants) within two weeks prior to initial IMD injection and to a minimum of four weeks post IMD injections
18. Any medical condition which, in the investigator's opinion, prohibits the inclusion in the study
19. Current or previous (within 30 days of enrolment) treatment with another investigational drug and/or medical device or participation in another clinical study
20. Previous enrolment in this clinical investigation
21. Any dependent relationship of the subject with the investigator, investigation site or Sponsor (e.g. employees or relatives)
22. Subjects whose participation in clinical trials is prohibited by the Austrian Medical Devices Act (e.g., persons with a legal custodian appointed due to mental disability, prisoners, soldiers and other members of the armed forces, civil servants)

Primary outcomes:
measure: Responder Rate in Lip Volume Improvement
timeFrame: Week 6
Secondary outcomes:
measure: Percentage of Responders Based on the Investigator Live Assessment
timeFrame: 6, 12 and optional 18 months
measure: Percentage of Responders Based on the Independent Photographic Reviewer´s Assessments
timeFrame: Week 6, Month 6, 12 and optional Month 18
measure: Percentage of Subjects With an Improvement Based on the Investigator Assessment Using GAIS
timeFrame: Week 6, Month 6, 12 and optional Month 18
measure: Percentage of Subjects With an Improvement Based on Subject Assessment Using GAIS
timeFrame: Week 6, Month 6, 12 and optional Month 18
measure: Subject Satisfaction Using Face-Q Questionnaire
timeFrame: Week 6, Month 6, 12 and optional Month 18
measure: Subject Satisfaction Using Face-Q TM Questionnaire "Satisfaction With Lips"
timeFrame: Week 6, Month 6, 12 and optional Month 18
measure: Subject's Perception of Pain Using the 11-point Numeric Pain Rating Scale
timeFrame: Day1, Week 3
measure: Percentage of Subjects Demonstrating an Aesthetic Effect
timeFrame: Week 6, Month 6, 12 and optional Month 18
measure: Injection Volume Required
timeFrame: Day1, Week 3
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medizinisch Aesthetisches Zentrum Wien
city: Vienna
country: Austria
facility: YUVELL - Home of Aesthetics
city: Vienna
country: Austria
facility: PW-Privatklinik Waehring GmbH
Study officials:
References: