Abnormal LipSayLipNCT04917588
Study to Evaluate the Effectiveness, Safety and Long Term Safety of Saypha® FILLER Lidocaine for Lip Augmentation
A study testing Saypha® FILLER Lidocaine (HQ) and Saypha® FILLER Lidocaine (C1) in people with Abnormal Lip, run by Croma-Pharma GmbH at 3 sites in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abnormal Lip
- What is being tested?
- Saypha® FILLER Lidocaine (HQ) and Saypha® FILLER Lidocaine (C1)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 3 sitesAustria
- Study dates
- 28 Jul 2020to 6 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country.
Austria3 sites
Medizinisch Aesthetisches Zentrum Wien
Vienna, 1010
YUVELL - Home of Aesthetics
Vienna, 1010
PW-Privatklinik Waehring GmbH
Vienna, 1180
About this study
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
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.
Read the 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.
- Conditions
- Abnormal Lip
- Being tested
- Saypha® FILLER Lidocaine (HQ), Saypha® FILLER Lidocaine (C1)
- Keywords
- Moderate to Severe Lip Volume Deficit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saypha® FILLER Lidocaine (HQ)Combination product
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.
Saypha® FILLER Lidocaine (C1)Combination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Saypha® FILLER HQ | Experimental | 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). Receives: Combination Product: Saypha® FILLER Lidocaine (HQ) |
| Saypha® FILLER C1 | Active comparator | 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). Receives: Combination Product: Saypha® FILLER Lidocaine (C1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Rate in Lip Volume Improvement
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.
Measured: Week 6
Secondary outcomes (9)
Percentage of Responders Based on the Investigator Live Assessment
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.
Measured: 6, 12 and optional 18 months
Percentage of Responders Based on the Independent Photographic Reviewer´s Assessments
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.
Measured: Week 6, Month 6, 12 and optional Month 18
Percentage of Subjects With an Improvement Based on the Investigator Assessment Using GAIS
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.
Measured: Week 6, Month 6, 12 and optional Month 18
Percentage of Subjects With an Improvement Based on Subject Assessment Using GAIS
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
Measured: Week 6, Month 6, 12 and optional Month 18
Subject Satisfaction Using Face-Q Questionnaire
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)).
Measured: Week 6, Month 6, 12 and optional Month 18
Subject Satisfaction Using Face-Q TM Questionnaire "Satisfaction With Lips"
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)).
Measured: Week 6, Month 6, 12 and optional Month 18
Subject's Perception of Pain Using the 11-point Numeric Pain Rating Scale
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.
Measured: Day1, Week 3
Percentage of Subjects Demonstrating an Aesthetic Effect
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"
Measured: Week 6, Month 6, 12 and optional Month 18
Injection Volume Required
Injection volume (initial and touch-up) required for an optimal augmentation of the lips with Saypha® FILLER Lidocaine.
Measured: Day1, Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start28 Jul 2020
- Primary completion14 Dec 2020
- Study completion6 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Abnormal LipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Croma-Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917588
- Sponsor's protocol ID
- CPH-101-201479
- Acronym
- SayLip
- Status last verified
- May 2022
- First submitted
- 26 May 2021
- Last updated
- 14 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04917588
- Acronym / sponsor ID
- SayLip / CPH-101-201479
- Conditions
- Abnormal Lip
- Keywords
- Moderate to Severe Lip Volume Deficit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Croma-Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 6 Apr 2022 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Posted 14 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saypha® FILLER HQ | Experimental | Combination Product: 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 | Active comparator | Combination Product: 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saypha® FILLER Lidocaine (HQ)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. | Combination product | Saypha® FILLER HQ |
| Saypha® FILLER Lidocaine (C1)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. | Combination product | Saypha® FILLER C1 |
Primary outcome
Responder Rate in Lip Volume Improvement
Time frame: 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.
9 secondary outcomes
Percentage of Responders Based on the Investigator Live Assessment
Time frame: 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
Percentage of Subjects With an Improvement Based on the Investigator Assessment Using GAIS
Time frame: 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
Subject Satisfaction Using Face-Q Questionnaire
Time frame: 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
Subject's Perception of Pain Using the 11-point Numeric Pain Rating Scale
Time frame: Day1, Week 3
Percentage of Subjects Demonstrating an Aesthetic Effect
Time frame: Week 6, Month 6, 12 and optional Month 18
Injection Volume Required
Time frame: Day1, Week 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saypha® FILLER Lidocaine (HQ) and Saypha® FILLER Lidocaine (C1) in people with Abnormal Lip, run by Croma-Pharma GmbH at 3 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder Rate in Lip Volume Improvement (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.