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

May 13, 2022 updated by: Croma-Pharma GmbH

A Prospective, Open-label, Multicentre, Randomized Study to Evaluate the Effectiveness, Safety and Long Term Safety of Saypha® FILLER Lidocaine for Lip Augmentation

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.

Study Overview

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 2, 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.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vienna, Austria, 1010
        • Dr. Doris Grablowitz
      • Vienna, Austria, 1010
        • YUVELL® Fine Aesthetics
      • Vienna, Austria, 1180
        • PW-Privatklinik Währing GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Saypha® FILLER 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 Lidocaine is administered by injection into the lips. The volume applied depends on the size of the area which requires correction and will be selected by the investigator. A maximum volume of 2 mL for both lips in total (i.e., for upper plus lower lip) including touch up might be needed per treatment but the treatment should not exceed 10 mL in total per treatment or 20 mL per year.
ACTIVE_COMPARATOR: Saypha® FILLER 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).

Saypha® FILLER Lidocaine is administered by injection into the lips. The volume applied depends on the size of the area which requires correction and will be selected by the investigator. A maximum volume of 2 mL for both lips in total (i.e., for upper plus lower lip) including touch up might be needed per treatment but the treatment should not exceed 10 mL in total per treatment or 20 mL per year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responder Rate in lip volume improvement
Time Frame: 6 Weeks
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).
6 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of responders based on the investigator live assessment
Time Frame: 6, 12 and optional 18 months
The percentage of responders, based on the investigator live assessment at 6, 12 and optional 18 months after the initial treatment using the validated LFS.
6, 12 and optional 18 months
Percentage of responders based on the independent photographic reviewer´s assessments
Time Frame: Week 6, Month 6, 12 and optional Month 18
The percentage of responders based on the independent photographic reviewer´s assessments before initial treatment and at Week 6, Month 6, 12 and optional Month 18 after initial treatment, based on photographs and using the validated LFS.
Week 6, Month 6, 12 and optional Month 18
Percentage of subjects with an improvement based on the investigator assessment using GAIS
Time Frame: 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.
Week 6, Month 6, 12 and optional Month 18
Percentage of subjects with an improvement based on subject assessment using GAIS
Time Frame: 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
Week 6, Month 6, 12 and optional Month 18
Subject Satisfaction using Face-Q questionnaire
Time Frame: 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 "Satisfaction with Outcome", a 6-item, Health-related Quality of Life Questionnaire with binary answer options (agree/disagree).
Week 6, Month 6, 12 and optional Month 18
Subject Satisfaction using Face-Q TM Questionnaire "Satisfaction with Lips"
Time Frame: 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 "not at all bothered" and "extremely bothered"
Week 6, Month 6, 12 and optional Month 18
Subject's perception of pain using the 11-point Numeric Pain Rating Scale
Time Frame: Day1
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.
Day1
Percentage of subjects demonstrating an aesthetic effect
Time Frame: 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.
Week 6, Month 6, 12 and optional Month 18
Injection volume required
Time Frame: Day1
Injection volume (initial and touch-up) required for an optimal augmentation of the lips with Saypha® FILLER Lidocaine.
Day1

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Through study completion, on average 12 Months
Occurrence and frequency of adverse events
Through study completion, on average 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Daniel Müller, Dr.
  • Principal Investigator: Doris Grablowitz, Dr.
  • Principal Investigator: Artur Worseg, Dr.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 28, 2020

Primary Completion (ACTUAL)

July 28, 2021

Study Completion (ACTUAL)

April 4, 2022

Study Registration Dates

First Submitted

May 26, 2021

First Submitted That Met QC Criteria

June 4, 2021

First Posted (ACTUAL)

June 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 16, 2022

Last Update Submitted That Met QC Criteria

May 13, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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