Trial Outcomes & Findings for Study to Evaluate the Effectiveness, Safety and Long Term Safety of Saypha® FILLER Lidocaine for Lip Augmentation (NCT NCT04917588)
NCT ID: NCT04917588
Last Updated: 2025-03-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
114 participants
Primary outcome timeframe
Week 6
Results posted on
2025-03-14
Participant Flow
Screened patients: N=121; Screening failures: N=7; Patients enrolled = Patients Treated with IMD: N= 114
Participant milestones
| Measure |
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 (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.
|
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 (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.
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
57
|
|
Overall Study
COMPLETED
|
50
|
51
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Effectiveness, Safety and Long Term Safety of Saypha® FILLER Lidocaine for Lip Augmentation
Baseline characteristics by cohort
| Measure |
Saypha® FILLER HQ
n=57 Participants
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 (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.
|
Saypha® FILLER C1
n=57 Participants
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 (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.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.1 years
STANDARD_DEVIATION 13.78 • n=5 Participants
|
44.4 years
STANDARD_DEVIATION 16.22 • n=7 Participants
|
43.2 years
STANDARD_DEVIATION 15.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
57 participants
n=5 Participants
|
57 participants
n=7 Participants
|
114 participants
n=5 Participants
|
|
Smoking habit
current
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Smoking habit
former
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Smoking habit
never smoked
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 6Population: Population considered for this analysis is the Full Analysis Set (FAS) which comprises all subjects who received at least 1 administration of the IMD and who had at least 1 post-treatment evaluation of the LFS. Individual LFS grades per visit are calculated separately for the upper and the lower lip.
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.
Outcome measures
| Measure |
Saypha® FILLER HQ
n=56 Participants
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 (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.
|
Saypha® FILLER C1
n=54 Participants
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 (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.
|
Overall Population (Saypha® FILLER HQ + Saypha® FILLER C1)
n=110 Participants
Total eligible subjects that had bilateral lip augmentation treatments with both Saypha® FILLER Lidocaine manufactured in the Croma Pharma C1 Facility and with Saypha® FILLER Lidocaine manufactured in the Croma Pharma in HQ facility.
|
|---|---|---|---|
|
Responder Rate in Lip Volume Improvement
lower lip responders
|
55 Participants
|
52 Participants
|
107 Participants
|
|
Responder Rate in Lip Volume Improvement
upper lip responders
|
53 Participants
|
53 Participants
|
106 Participants
|
SECONDARY outcome
Timeframe: 6, 12 and optional 18 monthsPopulation: FAS (defined in the Analyis Population description of the primary outcome measure) was considered for the analysis of the secondary endpoints.
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.
Outcome measures
| Measure |
Saypha® FILLER HQ
n=56 Participants
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 (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.
|
Saypha® FILLER C1
n=54 Participants
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 (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.
|
Overall Population (Saypha® FILLER HQ + Saypha® FILLER C1)
n=110 Participants
Total eligible subjects that had bilateral lip augmentation treatments with both Saypha® FILLER Lidocaine manufactured in the Croma Pharma C1 Facility and with Saypha® FILLER Lidocaine manufactured in the Croma Pharma in HQ facility.
|
|---|---|---|---|
|
Percentage of Responders Based on the Investigator Live Assessment
Month 6 Lower Lips
|
48 Participants
|
50 Participants
|
98 Participants
|
|
Percentage of Responders Based on the Investigator Live Assessment
Month 6 Upper Lips
|
49 Participants
|
50 Participants
|
99 Participants
|
|
Percentage of Responders Based on the Investigator Live Assessment
Month 12 Lower Lips
|
41 Participants
|
36 Participants
|
77 Participants
|
|
Percentage of Responders Based on the Investigator Live Assessment
Month 12 Upper Lips
|
38 Participants
|
36 Participants
|
74 Participants
|
|
Percentage of Responders Based on the Investigator Live Assessment
Month 18 Lower Lips
|
28 Participants
|
23 Participants
|
51 Participants
|
|
Percentage of Responders Based on the Investigator Live Assessment
Month 18 Upper Lips
|
24 Participants
|
19 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Week 6, Month 6, 12 and optional Month 18Population: FAS - see primary endopoint for FAS definition
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.
Outcome measures
| Measure |
Saypha® FILLER HQ
n=56 Participants
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 (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.
|
Saypha® FILLER C1
n=54 Participants
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 (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.
|
Overall Population (Saypha® FILLER HQ + Saypha® FILLER C1)
n=110 Participants
Total eligible subjects that had bilateral lip augmentation treatments with both Saypha® FILLER Lidocaine manufactured in the Croma Pharma C1 Facility and with Saypha® FILLER Lidocaine manufactured in the Croma Pharma in HQ facility.
|
|---|---|---|---|
|
Percentage of Responders Based on the Independent Photographic Reviewer´s Assessments
Week 6 - Lower Lip
|
25 Participants
|
30 Participants
|
55 Participants
|
|
Percentage of Responders Based on the Independent Photographic Reviewer´s Assessments
Week 6 - Upper Lip
|
17 Participants
|
25 Participants
|
42 Participants
|
|
Percentage of Responders Based on the Independent Photographic Reviewer´s Assessments
Month 6 - Lower Lip
|
20 Participants
|
19 Participants
|
39 Participants
|
|
Percentage of Responders Based on the Independent Photographic Reviewer´s Assessments
Month 6 - Upper Lip
|
15 Participants
|
24 Participants
|
39 Participants
|
|
Percentage of Responders Based on the Independent Photographic Reviewer´s Assessments
Month 12 - Lower Lip
|
20 Participants
|
15 Participants
|
35 Participants
|
|
Percentage of Responders Based on the Independent Photographic Reviewer´s Assessments
Month 12 - Upper Lip
|
20 Participants
|
26 Participants
|
46 Participants
|
|
Percentage of Responders Based on the Independent Photographic Reviewer´s Assessments
Month 18 - Lower Lip
|
15 Participants
|
16 Participants
|
31 Participants
|
|
Percentage of Responders Based on the Independent Photographic Reviewer´s Assessments
Month 18 - Upper Lip
|
13 Participants
|
21 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Week 6, Month 6, 12 and optional Month 18Population: FAS - Please see primary endpoint for definition
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.
Outcome measures
| Measure |
Saypha® FILLER HQ
n=56 Participants
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 (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.
|
Saypha® FILLER C1
n=54 Participants
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 (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.
|
Overall Population (Saypha® FILLER HQ + Saypha® FILLER C1)
n=110 Participants
Total eligible subjects that had bilateral lip augmentation treatments with both Saypha® FILLER Lidocaine manufactured in the Croma Pharma C1 Facility and with Saypha® FILLER Lidocaine manufactured in the Croma Pharma in HQ facility.
|
|---|---|---|---|
|
Percentage of Subjects With an Improvement Based on the Investigator Assessment Using GAIS
Week 6 -Lower Lip
|
56 Participants
|
54 Participants
|
110 Participants
|
|
Percentage of Subjects With an Improvement Based on the Investigator Assessment Using GAIS
Week 6 - Upper Lip
|
56 Participants
|
54 Participants
|
110 Participants
|
|
Percentage of Subjects With an Improvement Based on the Investigator Assessment Using GAIS
Month 6 - Lower Lip
|
53 Participants
|
53 Participants
|
106 Participants
|
|
Percentage of Subjects With an Improvement Based on the Investigator Assessment Using GAIS
Month 6 - Upper Lip
|
53 Participants
|
53 Participants
|
106 Participants
|
|
Percentage of Subjects With an Improvement Based on the Investigator Assessment Using GAIS
Month 12- Lower Lip
|
44 Participants
|
41 Participants
|
85 Participants
|
|
Percentage of Subjects With an Improvement Based on the Investigator Assessment Using GAIS
Month 12 - Upper Lip
|
44 Participants
|
40 Participants
|
84 Participants
|
|
Percentage of Subjects With an Improvement Based on the Investigator Assessment Using GAIS
Month 18 - Lower Lip
|
30 Participants
|
26 Participants
|
56 Participants
|
|
Percentage of Subjects With an Improvement Based on the Investigator Assessment Using GAIS
Month 18 -Upper Lip
|
30 Participants
|
21 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Week 6, Month 6, 12 and optional Month 18Population: FAS - please see primary endpoint description
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
Outcome measures
| Measure |
Saypha® FILLER HQ
n=56 Participants
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 (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.
|
Saypha® FILLER C1
n=54 Participants
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 (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.
|
Overall Population (Saypha® FILLER HQ + Saypha® FILLER C1)
n=110 Participants
Total eligible subjects that had bilateral lip augmentation treatments with both Saypha® FILLER Lidocaine manufactured in the Croma Pharma C1 Facility and with Saypha® FILLER Lidocaine manufactured in the Croma Pharma in HQ facility.
|
|---|---|---|---|
|
Percentage of Subjects With an Improvement Based on Subject Assessment Using GAIS
Month 12 - Upper Lips
|
44 Participants
|
44 Participants
|
88 Participants
|
|
Percentage of Subjects With an Improvement Based on Subject Assessment Using GAIS
Week 6 - lower lips
|
55 Participants
|
54 Participants
|
109 Participants
|
|
Percentage of Subjects With an Improvement Based on Subject Assessment Using GAIS
Week 6 - upper lips
|
56 Participants
|
54 Participants
|
110 Participants
|
|
Percentage of Subjects With an Improvement Based on Subject Assessment Using GAIS
Month 6 - Lower Lips
|
51 Participants
|
53 Participants
|
104 Participants
|
|
Percentage of Subjects With an Improvement Based on Subject Assessment Using GAIS
Month 6 - Upper Lips
|
53 Participants
|
53 Participants
|
106 Participants
|
|
Percentage of Subjects With an Improvement Based on Subject Assessment Using GAIS
Month 12 - Lower Lips
|
45 Participants
|
44 Participants
|
89 Participants
|
|
Percentage of Subjects With an Improvement Based on Subject Assessment Using GAIS
Month 18 - Lower Lips
|
37 Participants
|
34 Participants
|
71 Participants
|
|
Percentage of Subjects With an Improvement Based on Subject Assessment Using GAIS
Month 18 - Upper Lips
|
34 Participants
|
35 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: Week 6, Month 6, 12 and optional Month 18Population: The population considered for this analysis comprises all subjects who received at least 1 administration of the Investigational Medical Device, who had at least 1 post-treatment evaluation using the Lip Fullness Scale and who have Face-Q measurements available for the respective timepoints. In the protocol and statistical analysis plan, the analysis for this outcome measure was planned only for the overall population and not for the randomized subgroups Saypha® FILLER HQ and Saypha® FILLER C1.
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)).
Outcome measures
| Measure |
Saypha® FILLER HQ
n=110 Participants
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 (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.
|
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 (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.
|
Overall Population (Saypha® FILLER HQ + Saypha® FILLER C1)
Total eligible subjects that had bilateral lip augmentation treatments with both Saypha® FILLER Lidocaine manufactured in the Croma Pharma C1 Facility and with Saypha® FILLER Lidocaine manufactured in the Croma Pharma in HQ facility.
|
|---|---|---|---|
|
Subject Satisfaction Using Face-Q Questionnaire
Week 6
|
85.8 score on Face Q questionnaire
Standard Deviation 17.88
|
—
|
—
|
|
Subject Satisfaction Using Face-Q Questionnaire
Month 6
|
80.0 score on Face Q questionnaire
Standard Deviation 20.61
|
—
|
—
|
|
Subject Satisfaction Using Face-Q Questionnaire
Month 12
|
71.7 score on Face Q questionnaire
Standard Deviation 25.53
|
—
|
—
|
|
Subject Satisfaction Using Face-Q Questionnaire
Month 18
|
78.3 score on Face Q questionnaire
Standard Deviation 25.76
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 6, Month 6, 12 and optional Month 18Population: The population considered for this analysis comprises all subjects who received at least 1 administration of the Investigational Medical Device, who had at least 1 post-treatment evaluation using the Lip Fullness Scale and who have Face-Q measurements available for the respective timepoints. In the protocol and statistical analysis plan, the analysis for this outcome measure was planned only for the overall population and not for the randomized subgroups Saypha® FILLER HQ and Saypha® FILLER C1.
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)).
Outcome measures
| Measure |
Saypha® FILLER HQ
n=110 Participants
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 (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.
|
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 (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.
|
Overall Population (Saypha® FILLER HQ + Saypha® FILLER C1)
Total eligible subjects that had bilateral lip augmentation treatments with both Saypha® FILLER Lidocaine manufactured in the Croma Pharma C1 Facility and with Saypha® FILLER Lidocaine manufactured in the Croma Pharma in HQ facility.
|
|---|---|---|---|
|
Subject Satisfaction Using Face-Q TM Questionnaire "Satisfaction With Lips"
Week 6
|
90.9 score Face Q questionnaire
Standard Deviation 11.96
|
—
|
—
|
|
Subject Satisfaction Using Face-Q TM Questionnaire "Satisfaction With Lips"
Month 6
|
84.9 score Face Q questionnaire
Standard Deviation 17.24
|
—
|
—
|
|
Subject Satisfaction Using Face-Q TM Questionnaire "Satisfaction With Lips"
Month 12
|
76.2 score Face Q questionnaire
Standard Deviation 22.69
|
—
|
—
|
|
Subject Satisfaction Using Face-Q TM Questionnaire "Satisfaction With Lips"
Month 18
|
78.3 score Face Q questionnaire
Standard Deviation 20.45
|
—
|
—
|
SECONDARY outcome
Timeframe: Day1, Week 3Population: FAS-please see primary endpoint population definition
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.
Outcome measures
| Measure |
Saypha® FILLER HQ
n=110 Participants
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 (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.
|
Saypha® FILLER C1
n=56 Participants
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 (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.
|
Overall Population (Saypha® FILLER HQ + Saypha® FILLER C1)
n=54 Participants
Total eligible subjects that had bilateral lip augmentation treatments with both Saypha® FILLER Lidocaine manufactured in the Croma Pharma C1 Facility and with Saypha® FILLER Lidocaine manufactured in the Croma Pharma in HQ facility.
|
|---|---|---|---|
|
Subject's Perception of Pain Using the 11-point Numeric Pain Rating Scale
Initial Treatment - Immediately after treatment
|
3.3 score on a scale
Standard Deviation 1.71
|
3.6 score on a scale
Standard Deviation 1.75
|
3.0 score on a scale
Standard Deviation 1.62
|
|
Subject's Perception of Pain Using the 11-point Numeric Pain Rating Scale
Initial Treatment - 15 min post treatment
|
0.5 score on a scale
Standard Deviation 0.92
|
0.7 score on a scale
Standard Deviation 1.05
|
0.3 score on a scale
Standard Deviation 0.73
|
|
Subject's Perception of Pain Using the 11-point Numeric Pain Rating Scale
Touch up (Week 3) - Immediately after treatment
|
2.9 score on a scale
Standard Deviation 1.48
|
2.7 score on a scale
Standard Deviation 1.52
|
3.0 score on a scale
Standard Deviation 1.46
|
|
Subject's Perception of Pain Using the 11-point Numeric Pain Rating Scale
Touch up (Week 3 ) - 15 min post treatment
|
0.4 score on a scale
Standard Deviation 0.65
|
0.4 score on a scale
Standard Deviation 0.77
|
0.3 score on a scale
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: Week 6, Month 6, 12 and optional Month 18Population: The population considered for this analysis comprises all subjects who received at least 1 administration of the Investigational Medical Device and who had at least 1 post-treatment evaluation using the Lip Fullness Scale. In the protocol and statistical analysis plan, the analysis for this outcome measure was planned only for the overall population and not for the randomized subgroups Saypha® FILLER HQ and Saypha® FILLER C1.
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"
Outcome measures
| Measure |
Saypha® FILLER HQ
n=110 Participants
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 (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.
|
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 (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.
|
Overall Population (Saypha® FILLER HQ + Saypha® FILLER C1)
Total eligible subjects that had bilateral lip augmentation treatments with both Saypha® FILLER Lidocaine manufactured in the Croma Pharma C1 Facility and with Saypha® FILLER Lidocaine manufactured in the Croma Pharma in HQ facility.
|
|---|---|---|---|
|
Percentage of Subjects Demonstrating an Aesthetic Effect
Week 6
|
110 Participants
|
—
|
—
|
|
Percentage of Subjects Demonstrating an Aesthetic Effect
Month 6
|
106 Participants
|
—
|
—
|
|
Percentage of Subjects Demonstrating an Aesthetic Effect
Month 12
|
86 Participants
|
—
|
—
|
|
Percentage of Subjects Demonstrating an Aesthetic Effect
Month 18
|
59 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day1, Week 3Population: The population considered for this analysis comprises all subjects who had at least 1 post-treatment evaluation using the Lip Fullness Scale and who received treatment with the Investigational Medical Device at the respective timepoints. In the protocol and statistical analysis plan, the analysis for this outcome measure was planned only for the overall population and not for the randomized subgroups Saypha® FILLER HQ and Saypha® FILLER C1.
Injection volume (initial and touch-up) required for an optimal augmentation of the lips with Saypha® FILLER Lidocaine.
Outcome measures
| Measure |
Saypha® FILLER HQ
n=110 Participants
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 (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.
|
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 (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.
|
Overall Population (Saypha® FILLER HQ + Saypha® FILLER C1)
Total eligible subjects that had bilateral lip augmentation treatments with both Saypha® FILLER Lidocaine manufactured in the Croma Pharma C1 Facility and with Saypha® FILLER Lidocaine manufactured in the Croma Pharma in HQ facility.
|
|---|---|---|---|
|
Injection Volume Required
Day 1 - initial treatment -lower lip
|
0.79 ml
Standard Deviation 0.282
|
—
|
—
|
|
Injection Volume Required
Day 1 - Initial Treatment - Upper Lip
|
0.80 ml
Standard Deviation 0.285
|
—
|
—
|
|
Injection Volume Required
Day 1 - initial treatment - both lips
|
1.59 ml
Standard Deviation 0.516
|
—
|
—
|
|
Injection Volume Required
Week 3 - touch up treatment - lower lip
|
0.50 ml
Standard Deviation 0.298
|
—
|
—
|
|
Injection Volume Required
Week 3 - touch up treatment - upper lip
|
0.51 ml
Standard Deviation 0.305
|
—
|
—
|
|
Injection Volume Required
Week 3 - touch up treatment - both lips
|
0.85 ml
Standard Deviation 0.604
|
—
|
—
|
Adverse Events
Saypha® FILLER HQ
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Saypha® FILLER C1
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Saypha® FILLER HQ
n=57 participants at risk
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 (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.
|
Saypha® FILLER C1
n=57 participants at risk
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 (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.
|
|---|---|---|
|
Psychiatric disorders
Depression
|
0.00%
0/57 • Adverse events (AEs) were documented from the time of first IMD application at Baseline visit (Visit 1) throughout the course of the clinical investigation, which means up to 18 months after IMD application.
AEs will be detected at each visit by observation and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject. Open-ended and non-leading verbal questioning is the preferred method. In addition, the subjects will be instructed to immediately contact the investigator/investigation site in case of occurrence of any untoward event between visits and an unscheduled visit will be performed.
|
1.8%
1/57 • Number of events 1 • Adverse events (AEs) were documented from the time of first IMD application at Baseline visit (Visit 1) throughout the course of the clinical investigation, which means up to 18 months after IMD application.
AEs will be detected at each visit by observation and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject. Open-ended and non-leading verbal questioning is the preferred method. In addition, the subjects will be instructed to immediately contact the investigator/investigation site in case of occurrence of any untoward event between visits and an unscheduled visit will be performed.
|
Other adverse events
| Measure |
Saypha® FILLER HQ
n=57 participants at risk
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 (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.
|
Saypha® FILLER C1
n=57 participants at risk
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 (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.
|
|---|---|---|
|
General disorders
Application site pain
|
45.6%
26/57 • Number of events 30 • Adverse events (AEs) were documented from the time of first IMD application at Baseline visit (Visit 1) throughout the course of the clinical investigation, which means up to 18 months after IMD application.
AEs will be detected at each visit by observation and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject. Open-ended and non-leading verbal questioning is the preferred method. In addition, the subjects will be instructed to immediately contact the investigator/investigation site in case of occurrence of any untoward event between visits and an unscheduled visit will be performed.
|
36.8%
21/57 • Number of events 25 • Adverse events (AEs) were documented from the time of first IMD application at Baseline visit (Visit 1) throughout the course of the clinical investigation, which means up to 18 months after IMD application.
AEs will be detected at each visit by observation and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject. Open-ended and non-leading verbal questioning is the preferred method. In addition, the subjects will be instructed to immediately contact the investigator/investigation site in case of occurrence of any untoward event between visits and an unscheduled visit will be performed.
|
|
General disorders
Injection Site Bruising
|
29.8%
17/57 • Number of events 21 • Adverse events (AEs) were documented from the time of first IMD application at Baseline visit (Visit 1) throughout the course of the clinical investigation, which means up to 18 months after IMD application.
AEs will be detected at each visit by observation and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject. Open-ended and non-leading verbal questioning is the preferred method. In addition, the subjects will be instructed to immediately contact the investigator/investigation site in case of occurrence of any untoward event between visits and an unscheduled visit will be performed.
|
28.1%
16/57 • Number of events 22 • Adverse events (AEs) were documented from the time of first IMD application at Baseline visit (Visit 1) throughout the course of the clinical investigation, which means up to 18 months after IMD application.
AEs will be detected at each visit by observation and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject. Open-ended and non-leading verbal questioning is the preferred method. In addition, the subjects will be instructed to immediately contact the investigator/investigation site in case of occurrence of any untoward event between visits and an unscheduled visit will be performed.
|
|
General disorders
Injection site swelling
|
31.6%
18/57 • Number of events 22 • Adverse events (AEs) were documented from the time of first IMD application at Baseline visit (Visit 1) throughout the course of the clinical investigation, which means up to 18 months after IMD application.
AEs will be detected at each visit by observation and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject. Open-ended and non-leading verbal questioning is the preferred method. In addition, the subjects will be instructed to immediately contact the investigator/investigation site in case of occurrence of any untoward event between visits and an unscheduled visit will be performed.
|
28.1%
16/57 • Number of events 22 • Adverse events (AEs) were documented from the time of first IMD application at Baseline visit (Visit 1) throughout the course of the clinical investigation, which means up to 18 months after IMD application.
AEs will be detected at each visit by observation and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject. Open-ended and non-leading verbal questioning is the preferred method. In addition, the subjects will be instructed to immediately contact the investigator/investigation site in case of occurrence of any untoward event between visits and an unscheduled visit will be performed.
|
|
Infections and infestations
COVID 19
|
19.3%
11/57 • Number of events 13 • Adverse events (AEs) were documented from the time of first IMD application at Baseline visit (Visit 1) throughout the course of the clinical investigation, which means up to 18 months after IMD application.
AEs will be detected at each visit by observation and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject. Open-ended and non-leading verbal questioning is the preferred method. In addition, the subjects will be instructed to immediately contact the investigator/investigation site in case of occurrence of any untoward event between visits and an unscheduled visit will be performed.
|
12.3%
7/57 • Number of events 7 • Adverse events (AEs) were documented from the time of first IMD application at Baseline visit (Visit 1) throughout the course of the clinical investigation, which means up to 18 months after IMD application.
AEs will be detected at each visit by observation and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject. Open-ended and non-leading verbal questioning is the preferred method. In addition, the subjects will be instructed to immediately contact the investigator/investigation site in case of occurrence of any untoward event between visits and an unscheduled visit will be performed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place