18 and older, any sex, with Moderate to Severe Nasolabial Folds. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Responder Rate in Reduction of Nasolabial FoldsPrimary· 24 Weeks
The proportion of subjects with the NLF-SRS grade reduced by ≥1 point versus baseline at Week 24. This anaylsis is done per manufacturing site: C1 and HQ separately and for the overall population. A 'responder' is defined having at least ≥ 1 grade improvement as evaluated with the 5 point-validated NLF-SRS score on both sides of the face.
Nasolabial Folds Severity Rating Scale (NLF-SRS) is a validated 5 grade scale where the lower number corresponds to:
0 = None/minimal: No visible/minimal nasolabial folds;
1. = Mild: Shallow but visible nasolabial fold with a slight indentation;
2. = Moder
Group
Value
95% CI
Volume Lidocaine HQ
34
Volume Lidocaine C1
39
Overall Population (Saypha Volume Lidocaine HQ + C1)
73
Proportion of Responders at Other Time PointsSecondary· Week 4, week 36, week 52, week 65, week 78, week 104
The proportion of subjects with the NLF-SRS grade reduced by ≥1 point versus baseline at Week 4, Week 36, Week 52 and optional at Week 65, Week 78 and Week 104.
A reduction in the score of the Nasolabial Folds Severity Rating Scale is considered an improvement as this reflects a decrease of the folds severity which is rated from 0 (none/minimal) to 4 (extreme).
Individual NLF-SRS grades per visit calculated as the mean of grades assigned to the left and the right NLF, respectively
On the Nasolabial Fold-Severity Rating Scale (NLF-SRS) higher scores indicate a greater severity of the folds:
Week 4
Group
Value
95% CI
Volume Lidocaine HQ
46
Volume Lidocaine C1
46
Overall Population (Saypha Volume Lidocaine HQ + C1)
92
Week 36
Group
Value
95% CI
Volume Lidocaine HQ
27
Volume Lidocaine C1
32
Overall Population (Saypha Volume Lidocaine HQ + C1)
59
Week 52
Group
Value
95% CI
Volume Lidocaine HQ
10
Volume Lidocaine C1
13
Overall Population (Saypha Volume Lidocaine HQ + C1)
23
Week 65
Group
Value
95% CI
Volume Lidocaine HQ
3
Volume Lidocaine C1
3
Overall Population (Saypha Volume Lidocaine HQ + C1)
6
Week 78
Group
Value
95% CI
Volume Lidocaine HQ
1
Volume Lidocaine C1
0
Overall Population (Saypha Volume Lidocaine HQ + C1)
1
Week 104
Group
Value
95% CI
Volume Lidocaine HQ
0
Volume Lidocaine C1
0
Overall Population (Saypha Volume Lidocaine HQ + C1)
0
Change Versus Baseline in Nasolabial Fold SeveritrySecondary· Week 4, Week 24, Week 36, Week 52 and, optional at Week 65, Week 78 and Week 104
The average change versus baseline in the NLF-SRS (Nasolabial Folds Severity Rating Scale) grade at Week 4, Week 24, Week 36, Week 52 and, optional at Week 65, Week 78 and Week 104 as evaluated by the investigator.
A reduction in the score of the Nasolabial Folds Severity Rating Scale is considered an improvement as this reflects a decrease of the folds severity which is rated from 0 (none/minimal) to 4 (extreme).
Nasolabial Folds Severity Rating Scale (NLF-SRS) is a validated 5 grade scale where the lower number corresponds to:
0 = None/minimal: No visible/minimal nasolabial folds;
1. = M
Week 4
Group
Value
95% CI
Volume Lidocaine HQ
1.4
± 0.6
Volume Lidocaine C1
1.4
± 0.6
Overall Population (Saypha Volume Lidocaine HQ + C1)
1.4
± 0.6
Week 24
Group
Value
95% CI
Volume Lidocaine HQ
1.0
± 0.90
Volume Lidocaine C1
1.2
± 0.80
Overall Population (Saypha Volume Lidocaine HQ + C1)
1.1
± 0.90
Week 36
Group
Value
95% CI
Volume Lidocaine HQ
0.7
± 0.8
Volume Lidocaine C1
0.7
± 0.7
Overall Population (Saypha Volume Lidocaine HQ + C1)
0.7
± 0.8
Week 52
Group
Value
95% CI
Volume Lidocaine HQ
0.2
± 0.5
Volume Lidocaine C1
0.3
± 0.5
Overall Population (Saypha Volume Lidocaine HQ + C1)
0.2
± 0.5
Week 65
Group
Value
95% CI
Volume Lidocaine HQ
0.2
± 0.7
Volume Lidocaine C1
0.1
± 0.6
Overall Population (Saypha Volume Lidocaine HQ + C1)
0.1
± 0.6
Week 78
Group
Value
95% CI
Volume Lidocaine HQ
0.3
± 0.5
Volume Lidocaine C1
0.0
± 0.7
Overall Population (Saypha Volume Lidocaine HQ + C1)
0.2
± 0.6
Week 104
Group
Value
95% CI
Volume Lidocaine HQ
0.0
Overall Population (Saypha Volume Lidocaine HQ + C1)
0.0
Percentage of Responders With a ≥2-point ImprovementSecondary· Weeks 4, 24, 36, 52, 65, 78, and 104
Percentage of responders with a ≥2-point improvement over Baseline on the 5-point NLF-SRS, based on investigator's live assessment at Weeks 4, 24, 36, 52, 65, 78, and 104 after initial treatment.
On the Nasolabial Fold-Severity Rating Scale (NLF-SRS) higher scores indicate a greater severity of the folds: 0 = None/minimal: No visible/minimal nasolabial folds, 1 = Mild: Shallow but visible nasolabial fold with a slight indentation, 2 = Moderate: Moderately deep nasolabial fold, 3 = Severe: Very deep nasolabial fold with prominent facial feature, 4 = Extreme: Extremely deep and long nasolabial
Week 4
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
43
Week 24
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
32
Week 36
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
12
Week 52
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
0
Week 65
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
0
Week 78
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
0
Week 104
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
0
Percentage of Subjects With Aesthetic Improvement Using the 5-point GAIS Based on Investigator's AssessmentSecondary· Weeks 4, 24, 36, 52, 65, 78, and 104
Percentage of subjects with aesthetic improvement using the 5-point Global Aesthetzic Improvement Scavel (GAIS) (subjects who have been rated as "very much improved" or "much improved" or "improved"), based on investigator's assessment at Weeks 4, 24, 36, 52, 65, 78, and 104 after initial treatment, for each treatment location (right NLF, left NLF) separately and overall.
Week 4
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1) - Left Nasolabial Fold
0
Overall Population (Saypha Volume Lidocaine HQ + C1) - Right Nasolabial Fold
Percentage of Subjects With Aesthetic Improvement Using the 5-point GAIS Based on Subjects AssessmentSecondary· Weeks 4, 24, 36, 52, 65, 78, and 104
Percentage of subjects with aesthetic improvement using the 5-point Global Aesthetzic Improvement Scavel (GAIS) (subjects who have been rated as "very much improved" or "much improved" or "improved"), based on subject's assessment at Weeks 4, 24, 36, 52, 65, 78, and 104 after initial treatment, for each treatment location (right NLF, left NLF) separately and overall.
Week 4
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1) - Left Nasolabial Fold
3
Overall Population (Saypha Volume Lidocaine HQ + C1) - Right Nasolabial Fold
Percentage of Responders With a ≥1-point Improvement Over Baseline on the 5-point NLF-SRS, Based on Evaluation by an Independent Reviewer of PhotographsSecondary· Weeks 4, 36, 52, 65, 78, and 104
Percentage of responders with a ≥1-point improvement over Baseline on the 5-point NLF-SRS, based on evaluation by an independent reviewer of photographs for Weeks 4, 36, 52, 65, 78, and 104 after initial treatment.
On the Nasolabial Fold-Severity Rating Scale (NLF-SRS) higher scores indicate a greater severity of the folds: 0 = None/minimal: No visible/minimal nasolabial folds, 1 = Mild: Shallow but visible nasolabial fold with a slight indentation, 2 = Moderate: Moderately deep nasolabial fold, 3 = Severe: Very deep nasolabial fold with prominent facial feature, 4 = Extreme: Extremely deep a
Week 4 : Response Rate with improvement 1 grade
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
24
Week 4 : Response Rate with improvement 2 grades
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
3
Week 24 : Response Rate with improvement 1 grade
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
24
Week 24 : Response Rate with improvement 2 grades
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
0
Week 36 : Response Rate with improvement 1 grade
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
21
Week 36 : Response Rate with improvement 2 grades
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
0
Week 52 : Response Rate with improvement 1 grade
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
19
Week 52 : Response Rate with improvement 2 grades
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
1
Subject Satisfaction With Outcome of the Treatment, Assessed by the Face-Q Questionnaire "Satisfaction With Outcome"Secondary· Weeks 4, 24, 36, 52, 65, 78, and 104
Descriptive summary statistics for extent of subject satisfaction with outcome of the treatment, as assessed by the Face-Q questionnaire "Satisfaction with Outcome" at Weeks 4, 24, 36, 52, 65, 78, and 104 after initial treatment.
Face-Q TM Questionnaire "Satisfaction with Outcome", a 6- tem, Health-related Quality of Life Questionnaire: The raw summed scale score is converted to a score from 0 to 100 by using the transformed sum score (Rasch model): Modified sum score ranges from 0 to 100 (low numbers correspond to low satisfaction).
Week 4
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
76.8
± 18.9
Week 24
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
71.1
± 23.7
Week 36
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
62.2
± 25.3
Week 52
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
60.1
± 27.9
Week 65
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
83.9
± 18.0
Week 78
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
77.4
± 23.1
Week 104
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
59.0
Pain Intensity, as Evaluated by the Subject Using an 11-point NPRSSecondary· Day 0 and Week 2.
Descriptive summary statistics for pain intensity, as evaluated by the subject using an 11-point NPRS (where 0 is no pain and 10 is the worst pain imaginable) immediately after the last injection and 15 minutes thereafter, at Day 0 and optional at Week 2.
Injection at Day 0 - immediately after injection
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
1.4
± 1.4
Injection at Day 0 - 15 minutes after injection
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
0.0
± 0.2
Injection at Week 2 - immediately after injection
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
0.8
± 1.1
Injection at Week 2 - 15 minutes after injection
Group
Value
95% CI
Overall Population (Saypha Volume Lidocaine HQ + C1)
0.0
± 0.0
Percentage of Subjects Having an Aesthetic EffectSecondary· Weeks 24, 36, 52, 65, 78, and 104
Percentage of subjects having an aesthetic effect, based on the investigator's life assessment at Weeks 24, 36, 52, 65, 78, and 104.
Week 24
Group
Value
95% CI
Volume Lidocaine HQ
43
Volume Lidocaine C1
47
Overall Population (Saypha Volume Lidocaine HQ + C1)
90
Volume Lidocaine HQ
10
Volume Lidocaine C1
6
Overall Population (Saypha Volume Lidocaine HQ + C1)
16
Week 36
Group
Value
95% CI
Volume Lidocaine HQ
30
Volume Lidocaine C1
35
Overall Population (Saypha Volume Lidocaine HQ + C1)
65
Volume Lidocaine HQ
23
Volume Lidocaine C1
18
Overall Population (Saypha Volume Lidocaine HQ + C1)
41
Week 52
Group
Value
95% CI
Volume Lidocaine HQ
14
Volume Lidocaine C1
17
Overall Population (Saypha Volume Lidocaine HQ + C1)
31
Volume Lidocaine HQ
39
Volume Lidocaine C1
35
Overall Population (Saypha Volume Lidocaine HQ + C1)
74
Week 65
Group
Value
95% CI
Volume Lidocaine HQ
5
Volume Lidocaine C1
5
Overall Population (Saypha Volume Lidocaine HQ + C1)
10
Volume Lidocaine HQ
8
Volume Lidocaine C1
11
Overall Population (Saypha Volume Lidocaine HQ + C1)
19
Week 78
Group
Value
95% CI
Volume Lidocaine HQ
1
Volume Lidocaine C1
0
Overall Population (Saypha Volume Lidocaine HQ + C1)
1
Volume Lidocaine HQ
5
Volume Lidocaine C1
5
Overall Population (Saypha Volume Lidocaine HQ + C1)
10
Week 104
Group
Value
95% CI
Volume Lidocaine HQ
0
Volume Lidocaine C1
0
Overall Population (Saypha Volume Lidocaine HQ + C1)
0
Volume Lidocaine HQ
1
Volume Lidocaine C1
0
Overall Population (Saypha Volume Lidocaine HQ + C1)
1
The Proportion of Subjects With the NLF-SRS Grade Reduced by ≥1 Point Versus Baseline by Injection Technique and DeviceSecondary· Week 4, Week 24, Week 36, Week 52 and, optional at Week 65, Week 78 and Week 104
The proportion of subjects with the NLF-SRS grade reduced by ≥1 point versus Baseline at Weeks 4, 24, 36, 52, 65, 78, and 104 by injection technique (retrograde, bolus) and device (needle, cannula).
A reduction in the score of the Nasolabial Folds Severity Rating Scale is considered an improvement as this reflects a decrease of the folds severity which is rated from 0 (none/minimal) to 4 (extreme).
Nasolabial Folds Severity Rating Scale (NLF-SRS) is a validated 5 grade scale where the lower number corresponds to:
0 = None/minimal: No visible/minimal nasolabial folds;
1. = Mild: Shallow but
Week 4 after initial treatment
Group
Value
95% CI
Subgroup 'Retrograde Technique'
50
Subgroup "Bolus Technique"
42
Subgroup "Needle"
50
Subgroup "Cannula"
42
Week 24 after initial treatment
Group
Value
95% CI
Subgroup 'Retrograde Technique'
40
Subgroup "Bolus Technique"
33
Subgroup "Needle"
40
Subgroup "Cannula"
33
Week 36 after initial treatment
Group
Value
95% CI
Subgroup 'Retrograde Technique'
36
Subgroup "Bolus Technique"
23
Subgroup "Needle"
29
Subgroup "Cannula"
30
Week 52 after initial treatment
Group
Value
95% CI
Subgroup 'Retrograde Technique'
13
Subgroup "Bolus Technique"
10
Subgroup "Needle"
15
Subgroup "Cannula"
8
Week 65 after initial treatment
Group
Value
95% CI
Subgroup 'Retrograde Technique'
2
Subgroup "Bolus Technique"
4
Subgroup "Needle"
5
Subgroup "Cannula"
1
Week 78 after initial treatment
Group
Value
95% CI
Subgroup 'Retrograde Technique'
1
Subgroup "Bolus Technique"
0
Subgroup "Needle"
1
Subgroup "Cannula"
0
Week 104 after initial treatment
Group
Value
95% CI
Subgroup 'Retrograde Technique'
0
Subgroup "Bolus Technique"
0
Subgroup "Needle"
0
Subgroup "Cannula"
0
Average Change Versus Baseline in the NLF-SRS Grade at Week 4, 24, 36, 52, 65, 78, and 104 as Evaluated by the Investigator by Injection Technique ('Retrograde', 'Bolus') and Device ('Needle', 'Cannula')Secondary· Week 4, 24, 36, 52, 65, 78, and 104
The average change versus Baseline in the NLF-SRS grade at Weeks 4, 24, 36, 52, 65, 78, and 104 as evaluated by the investigator by injection technique ('retrograde', 'bolus') and device ('needle', 'cannula')
On the Nasolabial Fold-Severity Rating Scale (NLF-SRS) higher scores indicate a greater severity of the folds: 0 = None/minimal: No visible/minimal nasolabial folds, 1 = Mild: Shallow but visible nasolabial fold with a slight indentation, 2 = Moderate: Moderately deep nasolabial fold, 3 = Severe: Very deep nasolabial fold with prominent facial feature, 4 = Extreme: Extremely deep and lon
Week 4
Group
Value
95% CI
Subgroup 'Retrograde Technique'
1.5
± 0.5
Subgroup "Bolus Technique"
1.3
± 0.7
Subgroup "Needle"
1.4
± 0.6
Subgroup "Cannula"
1.5
± 0.5
Week 24
Group
Value
95% CI
Subgroup 'Retrograde Technique'
1.1
± 0.9
Subgroup "Bolus Technique"
1.0
± 0.9
Subgroup "Needle"
1.0
± 0.8
Subgroup "Cannula"
1.2
± 0.9
Week 36
Group
Value
95% CI
Subgroup 'Retrograde Technique'
0.8
± 0.7
Subgroup "Bolus Technique"
0.6
± 0.8
Subgroup "Needle"
0.6
± 0.8
Subgroup "Cannula"
0.9
± 0.7
Week 52
Group
Value
95% CI
Subgroup 'Retrograde Technique'
0.3
± 0.5
Subgroup "Bolus Technique"
0.2
± 0.5
Subgroup "Needle"
0.2
± 0.5
Subgroup "Cannula"
0.3
± 0.4
Week 65
Group
Value
95% CI
Subgroup 'Retrograde Technique'
0.1
± 0.6
Subgroup "Bolus Technique"
0.3
± 0.8
Subgroup "Needle"
0.2
± 0.7
Subgroup "Cannula"
0.0
± 0.6
Week 78
Group
Value
95% CI
Subgroup 'Retrograde Technique'
0.2
± 0.8
Subgroup "Bolus Technique"
0.2
± 0.4
Subgroup "Needle"
0.3
± 0.7
Subgroup "Cannula"
0.0
± 0.0
Week 104
Group
Value
95% CI
Subgroup 'Retrograde Technique'
0.0
Subgroup "Needle"
0.0
Adverse events — posted to ClinicalTrials.gov
Time frame: 65 weeks. From day 0 ( IMP administration) until visit 9 ( week 65)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Volume Lidocaine HQ
Serious: 1/54 (2%)
Deaths: 0/54
Volume Lidocaine C1
Serious: 2/55 (4%)
Deaths: 0/55
Overall Population (Saypha Volume Lidocaine HQ + C1)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Croma-Pharma GmbH
Last refreshed: 3 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04883632.