Study to Evaluate the Effectiveness, Safety and Long Term Safety of Saypha® FILLER Lidocaine for Lip Augmentation

Not Applicable

Completed

Conditions: Abnormal Lip

Interventions: Combination Product: Saypha® FILLER Lidocaine (HQ)
Combination Product: Saypha® FILLER Lidocaine (C1)

Registration Number: NCT04917588

Lead Sponsor: Croma-Pharma GmbH

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 114

Inclusion Criteria

Adult female or male subjects 18 years of age at Screening/Baseline visit (Visit 1)
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
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
Healthy skin in the treatment area and free of diseases that could interfere in evaluation of treatment
Willingness to abstain from any cosmetic or surgical procedures in the treatment area for the duration of the clinical investigation
Willingness to take part in this clinical investigation documented by a personally signed/dated informed consent.

Exclusion Criteria

Pregnancy, lactation, planned pregnancy or unwillingness to use contraception at any time during the study (for women of child-bearing potential only)
History of mental disorders or emotional instability
History of allergic reaction or hypersensitivity to hyaluronic acid, lidocaine or any amide-based anaesthetic
Prior surgery, scars or tattoo to the upper or lower lip or lip line; surgery and tattooing are prohibited until end of clinical investigation
Tooth gap, overbite, beard longer three-day beard, or excessive facial hair that could interfere in evaluation of treatment as judged by the investigator
Presence of any abnormal lip structure, such as a scar or lump or severe lip asymmetry, as judged by the investigator
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
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
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
Presence of cutaneous lesions, inflammatory and/or infectious processes (e.g. acne, herpes, etc.) or proliferative lesions in the treatment area
Known human immune deficiency virus-positive individuals
History of allergies against aesthetic filling products and recurrent (3 times a year) herpes simplex in the treated area
Tendency to hypertrophic scars, keloid formation and/or pigmentation disorders
History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy
Uncontrolled systemic diseases (such as diabetes mellitus)
Use of anticoagulant, antiplatelet or thrombolytic medication (e.g. acetylsalicylic acid) from 10 days pre- to three days post IMD injections
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
Any medical condition which, in the investigator's opinion, prohibits the inclusion in the study
Current or previous (within 30 days of enrolment) treatment with another investigational drug and/or medical device or participation in another clinical study
Previous enrolment in this clinical investigation
Any dependent relationship of the subject with the investigator, investigation site or Sponsor (e.g. employees or relatives)
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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saypha® FILLER HQ	Saypha® FILLER Lidocaine (HQ)	Eligible subjects will undergo bilateral lip augmentation treatments with Saypha® FILLER Lidocaine manufactured in the Croma Pharma HQ Facility in order to correct moderate to severe deficiency of lip volume. The treatment will be administered at the Baseline visit (Day 0).
Saypha® FILLER C1	Saypha® FILLER Lidocaine (C1)	Eligible subjects will undergo bilateral lip augmentation treatments with Saypha® FILLER Lidocaine manufactured in the Croma Pharma C1 Facility in order to correct moderate to severe deficiency of lip volume. The treatment will be administered at the Baseline visit (Day 0).

Primary Outcome Measures

Name	Time	Method
Responder Rate in Lip Volume Improvement	Week 6	The proportion of subjects ('responders') with the lip volume improved by ≥1 point versus baseline value at 6 weeks after initial treatment based on the investigator live assessment using the validated Lip Fullness Scale (LFS). Lip Fullness Scale (LFS) is a validated 5-point rating scale,that evaluates the Lip Volume Deficiency ranging from Grade 1 (minimal volume) to Grade 5 (very significant volume): In this case, the bigger the number, the better.

Secondary Outcome Measures

Name	Time	Method
Percentage of Responders Based on the Investigator Live Assessment	6, 12 and optional 18 months	The percentage of responders (with the Lip Volume Improved by \>=1 Point Versus Baseline Value,) based on the investigator live assessment at 6, 12 and optional 18 months after the initial treatment using the validated LFS. Lip Fullness Scale (LFS) is a validated 5-point rating scale,that evaluates the Lip Volume Deficiency ranging from Grade 1 (minimal volume) to Grade 5 (very significant volume): In this case, the bigger the number, the better.
Percentage of Responders Based on the Independent Photographic Reviewer´s Assessments	Week 6, Month 6, 12 and optional Month 18	The percentage of responders based on the independent photographic reviewer´s assessments at Week 6, Month 6, 12 and optional Month 18 after initial treatment, based on photographs and using the validated LFS (compared to Baseline). Lip Fullness Scale (LFS) is a validated 5-point rating scale,that evaluates the Lip Volume Deficiency ranging from Grade 1 (minimal), Grade 2 (slight), Grade 3 (moderately thick), Grade 4 (thick), to Grade 5 (very significant): In this case, the bigger the number, the better.
Percentage of Subjects With an Improvement Based on the Investigator Assessment Using GAIS	Week 6, Month 6, 12 and optional Month 18	The percentage of subjects with an improvement relative to baseline photographs, (subjects who have been rated as "very much improved" or "much improved" or "improved"), based on the investigator assessment at Week 6, Month 6, 12 and optional Month 18 after initial treatment using the 5-point GAIS.
Percentage of Subjects With an Improvement Based on Subject Assessment Using GAIS	Week 6, Month 6, 12 and optional Month 18	The percentage of subjects with an improvement relative to baseline photographs (subjects who have been rated as "very much improved" or "much improved" or "improved"), based on subject assessment at Week 6, Month 6, 12 and optional Month 18 after initial treatment, using the 5-point GAIS with results ranging from 1 to 5 with lower numbers indicating better improvement
Subject Satisfaction Using Face-Q Questionnaire	Week 6, Month 6, 12 and optional Month 18	The extent of subject´s satisfaction with overall outcome of the treatment, at Week 6, Month 6, 12 and optional Month 18 after initial treatment, assessed by the subject using the Face-Q TM Questionnaire. The FACE-Q Satisfaction with Outcome scale is a patient-reported outcome measure designed to assess a patient's satisfaction with the results of a facial aesthetic procedure. This scale comprises six items, each with four response options: "definitely agree," "somewhat agree," "somewhat disagree," and "definitely disagree." The raw summed scale score is converted to a score from 0 to 100 by using the respective Conversion Tables available from Face Q authors. Higher scores reflect a better outcome (i.e., 0 (worst) to 100 (best)).
Subject Satisfaction Using Face-Q TM Questionnaire "Satisfaction With Lips"	Week 6, Month 6, 12 and optional Month 18	The extent of subject's satisfaction with augmentation of lips, at Week 6, Month 6, 12 and optional Month 18 after initial treatment, assessed by the subject using the Face-Q TM Questionnaire "Satisfaction with Lips", a 6-items Aesthetic Appearance Questionnaire with 5 pre-defined answer options between "very satisfied" and "very dissatisfied". The extent of subject´s satisfaction with overall outcome of the treatment, at Week 6, Month 6, 12 and optional Month 18 after initial treatment, assessed by the subject using the Face-Q. The raw summed scale score is converted to a score from 0 to 100 by using the respective Conversion Tables available from Face Q authors. Higher scores reflect a better outcome (i.e., 0 (worst) to 100 (best)).
Subject's Perception of Pain Using the 11-point Numeric Pain Rating Scale	Day1, Week 3	Subject's perception of pain after initial and touch-up treatment with Saypha® FILLER Lidocaine using the 11-point Numeric Pain Rating Scale (NPRS), where 0 is no pain and 10 is the worst pain imaginable.
Percentage of Subjects Demonstrating an Aesthetic Effect	Week 6, Month 6, 12 and optional Month 18	Percentage of subjects demonstrating an aesthetic effect at Week 6, Month 6, 12 and optional Month 18 based on the investigator's life assessment. A live assessment of the treated areas was performed and the treated areas compared to the subject's photographs obtained at the Baseline Visit. The presence of the aesthetic effect was recorded as either "Yes" or "No"
Injection Volume Required	Day1, Week 3	Injection volume (initial and touch-up) required for an optimal augmentation of the lips with Saypha® FILLER Lidocaine.

Trial Locations

Locations (3): Medizinisch Aesthetisches Zentrum Wien
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Vienna, Austria
YUVELL - Home of Aesthetics
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Vienna, Austria
PW-Privatklinik Waehring GmbH
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Vienna, Austria