Trial · NCT05386030
Saypha® VOLUME Lidocaine for Midface Augmentation
NCT05386030, Phase 3, Completed, Croma-Pharma GmbH; results first posted 2025-01-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Saypha® VOLUME Lidocaine for Midface Augmentation. Trials, record NCT05386030. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05386030
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Saypha® VOLUME Lidocaine for Midface Augmentation
- NCT number
- NCT05386030
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 562 participants, actual
- Lead sponsor
- Croma-Pharma GmbH
- Conditions
- Moderate to Severe Midface Volume Deficit
- Interventions
- saypha® VOLUME Lidocaine, Juvéderm® Voluma™ XC
- First posted
- 2022-05-23
- Last updated
- 2026-04-09
- Results first posted
- 2025-01-16
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Per Protocol Dataset | Week 24 | The percentage of responders on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit) based on the blinded evaluator´s live assessment at Week 24 after last injection of initial treatment phase compared to the pre-treatment score at Baseline visit. Subjects are defined as responders if they are showing an \>=1 point improvement in MVDSS at Week 24 relative to baseline. |
| Primary | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Full Analysis Dataset | Week 24 | The percentage of responders on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit) based on the blinded evaluator´s live assessment at Week 24 after last injection of initial treatment phase compared to the pre-treatment score at Baseline visit. Subjects are defined as responders if they are showing an \>=1 point improvement in MVDSS at Week 24 relative to baseline. Subjects with missing baseline MVDSS score and / or missing MVDSS score at Week 24 after last injection of the initial treatment phase were imputed as non-responders. |
| Secondary | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 36, and 48 as Rated by the Blinded Evaluator | Weeks 4, 8, 16, 36, and 48 | The percentage of responders on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit), based on the blinded evaluator´s live assessment at Weeks 4, 8, 16, 36, and 48 after last injection of initial treatment compared to the score at Baseline. Subjects are defined as responders if they are showing an \>=1 point improvement in MVDSS at the respective visit relative to baseline. |
| Secondary | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 24, 36, and 48 as Rated by the Independent Blinded Photographic Reviewer | Weeks 4, 8, 16, 24, 36, and 48 | The percentage of responders on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit), based on the independent blinded photographic reviewer´s assessment by using photographs at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment compared to the score at Baseline. The median of all assessments for the same photograph were taken into account. |
| Secondary | Mean Change in Midface Volume Deficit | Weeks 4, 8, 16, 24, 36, and 48 | Mean change in midface volume deficit measured on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit), and based on the blinded evaluator´s live assessment at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment compared to the score at Baseline. |
| Secondary | Mean Change in Midface Volume Deficit as Measured by Volumetric Change Measurement | Weeks 4, 8, 16, 24, 36, and 48 | Mean change in midface volume deficit as measured by volumetric change measurement by using 3D digital photographic images at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment compared to Baseline. |
| Secondary | Change in Nasolabial Folds Measurements | Weeks 4, 8, 16, 24, 36, and 48 | Shift from baseline in nasolabial folds measured by the 5-point validated NLF-SRS (Nasolabial Folds Severity Rating Scale, where 0 means no NLF and 4 means Extreme Nasolabial fold) based on the blinded evaluator´s live assessment at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment. |
| Secondary | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator | Weeks 4, 8, 16, 24, 36, and 48 | The percentage of subjects with a global aesthetic improvement over baseline (subjects who have been rated as "much improved" or "improved"), based on the blinded evaluator's assessment at Weeks 4, 8, 16, 24, 36, and 48, after last injection of initial treatment phase using the 5-point modified Global Aesthetic Improvement Scale (GAIS). The blinded evaluators assess aesthetic improvement via photographs comparing baseline photos against the respective study visit week photo with the following possible 5 outcomes: "Much worse", "Worse", "No change", "Improved", "Much improved". |
| Secondary | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject | Weeks 4, 8, 16, 24, 36, and 48 | The percentage of subjects with a global aesthetic improvement over baseline (subjects who have been rated as "much improved" or "improved"), based on the subject's assessment at Weeks 4, 8, 16, 24, 36, and 48, after last injection of initial treatment phase using the 5-point modified Global Aesthetic Improvement Scale (GAIS). The subjects assess aesthetic improvement via photographs comparing baseline photos against the respective study visit week photo with the following possible 5 outcomes: "Much worse", "Worse", "No change", "Improved", "Much improved". |
| Secondary | Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects | Weeks 4, 8, 16, 24, 36, and 48 | The extent of subject's satisfaction with overall treatment outcome at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment phase as assessed by the subject using the Face-Q(TM) Questionnaire "Satisfaction with Outcome". This validated patient reported outcome is based on subject's answers to pre-specified questions with answers ranging as 1="Definitely disagree", 2="Somewhat disagree", 3="Somewhat agree", 4="Definitely agree". The answers are mathematically transferred to one single numerical result between 100 and 0, where 100 reflects the highest possible satisfaction and 0 means the lowest possible satisfaction. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Per Protocol Dataset | Week 24 | The population used consists of all randomized subjects, who received at least one administration of the test device or the comparator device and who did not have any major protocol deviation affecting the primary effectiveness endpoint. Subjects with missing baseline Mid-Face Volume Deficit Severity Scale (MVDSS) score and / or missing MVDSS score at Week 24 after last injection of the initial treatment phase were not included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Full Analysis Dataset | Week 24 | The population used consists of all randomized subjects, who received at least one administration of the test device or the comparator device. Participants were analyzed as randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 36, and 48 as Rated by the Blinded Evaluator | Weeks 4, 8, 16, 36, and 48 | The population used consists of all randomized subjects, who received at least one administration of the test device or the comparator device and have data available for the respective visit. Participants were analyzed as randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 24, 36, and 48 as Rated by the Independent Blinded Photographic Reviewer | Weeks 4, 8, 16, 24, 36, and 48 | The population used consists of all randomized subjects, who received at least one administration of the test device or the comparator device and who have data available for the respective visit. Participants were analyzed as randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change in Midface Volume Deficit | Weeks 4, 8, 16, 24, 36, and 48 | The population used consists of all randomized subjects, who received at least one administration of the test device or the comparator device and who have data available for the respective visit. Participants were analyzed as randomized. | score on a scale | MEAN |
| SECONDARY | Mean Change in Midface Volume Deficit as Measured by Volumetric Change Measurement | Weeks 4, 8, 16, 24, 36, and 48 | The population used consists of all randomized subjects, who received at least one administration of the test device or the comparator device and who have data available at the respective visit. Participants were analyzed as randomized. | cm^3 | MEAN |
| SECONDARY | Change in Nasolabial Folds Measurements | Weeks 4, 8, 16, 24, 36, and 48 | The population used consists of all randomized subjects, who received at least one administration of the test device or the comparator device and who have data available at the respective visit. Participants were analyzed as randomized. | units on a scale | MEAN |
| SECONDARY | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator | Weeks 4, 8, 16, 24, 36, and 48 | The population used consists of all randomized subjects who received at least one injection with study medication and for whom data are available at the respective timepoint. Participants were analyzed as randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject | Weeks 4, 8, 16, 24, 36, and 48 | The population used consists of all randomized subjects who received at least one injection with study medication and for whom data are available at the respective timepoint. Participants were analyzed as randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects | Weeks 4, 8, 16, 24, 36, and 48 | The population used consists of all randomized subjects who received at least one injection with study medication and for whom data are available at the respective timepoint. Participants were analyzed as randomized. | score on a scale | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group164
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Per Protocol Dataset | Saypha® VOLUME Lidocaine | 268 | Participants | ||
| The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Per Protocol Dataset | Juvéderm® Voluma™ XC | 124 | Participants | ||
| The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Full Analysis Dataset | Saypha® VOLUME Lidocaine | 283 | Participants | ||
| The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Full Analysis Dataset | Juvéderm® Voluma™ XC | 135 | Participants | ||
| The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 36, and 48 as Rated by the Blinded Evaluator | Saypha® VOLUME Lidocaine | Week 4 | 291 | Participants | |
| The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 36, and 48 as Rated by the Blinded Evaluator | Juvéderm® Voluma™ XC | Week 4 | 149 | Participants | |
| The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 36, and 48 as Rated by the Blinded Evaluator | Saypha® VOLUME Lidocaine | Week 8 | 294 | Participants | |
| The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 36, and 48 as Rated by the Blinded Evaluator | Juvéderm® Voluma™ XC | Week 8 | 147 | Participants | |
| The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 36, and 48 as Rated by the Blinded Evaluator | Saypha® VOLUME Lidocaine | Week 16 | 286 | Participants | |
| The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 36, and 48 as Rated by the Blinded Evaluator | Juvéderm® Voluma™ XC | Week 16 | 147 | Participants |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Saypha® VOLUME Lidocaine | 324 | |
| Overall Study | STARTED | Juvéderm® Voluma™ XC | 162 | |
| Overall Study | Received Treatment | Saypha® VOLUME Lidocaine | 322 | |
| Overall Study | Received Treatment | Juvéderm® Voluma™ XC | 161 | |
| Overall Study | COMPLETED | Saypha® VOLUME Lidocaine | 280 | |
| Overall Study | COMPLETED | Juvéderm® Voluma™ XC | 143 | |
| Overall Study | NOT COMPLETED | Saypha® VOLUME Lidocaine | 44 | |
| Overall Study | NOT COMPLETED | Juvéderm® Voluma™ XC | 19 |
Source ClinicalTrials.gov
Adverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vision blurred | Eye disorders | Saypha® VOLUME Lidocaine | 8 | 322 | 8 |
| other | Vision blurred | Eye disorders | Juvéderm® Voluma™ XC | 1 | 161 | 1 |
| other | Injection site bruising | General disorders | Saypha® VOLUME Lidocaine | 6 | 322 | 6 |
| other | Injection site bruising | General disorders | Juvéderm® Voluma™ XC | 5 | 161 | 6 |
| other | Injection site pain | General disorders | Saypha® VOLUME Lidocaine | 8 | 322 | 10 |
| other | Injection site pain | General disorders | Juvéderm® Voluma™ XC | 1 | 161 | 1 |
| other | COVID-19 | Infections and infestations | Saypha® VOLUME Lidocaine | 16 | 322 | 16 |
| other | COVID-19 | Infections and infestations | Juvéderm® Voluma™ XC | 5 | 161 | 5 |
| other | Nasopharyngitis | Infections and infestations | Saypha® VOLUME Lidocaine | 7 | 322 | 7 |
| other | Nasopharyngitis | Infections and infestations | Juvéderm® Voluma™ XC | 6 | 161 | 7 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Saypha® VOLUME Lidocaine | 1 | 322 |
| Total, all-cause mortality | Juvéderm® Voluma™ XC | 0 | 161 |
| Total, other adverse events | Saypha® VOLUME Lidocaine | 84 | 322 |
| Total, other adverse events | Juvéderm® Voluma™ XC | 41 | 161 |
| Total, serious adverse events | Saypha® VOLUME Lidocaine | 4 | 322 |
| Total, serious adverse events | Juvéderm® Voluma™ XC | 2 | 161 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Saypha® VOLUME Lidocaine vs Juvéderm® Voluma™ XC: The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Per Protocol Dataset | Trial comparisons |
| Saypha® VOLUME Lidocaine vs Juvéderm® Voluma™ XC: The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Full Analysis Dataset | Trial comparisons |
| Saypha® VOLUME Lidocaine vs Juvéderm® Voluma™ XC: deaths from any cause | Trial comparisons |
| Saypha® VOLUME Lidocaine vs Juvéderm® Voluma™ XC: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05386030
GET https://conductscience.org/api/trials/v1/NCT05386030/results?page=2