Post-Approval Study of Saypha® ChIQ™ for Midface Augmentation in Subjects With Fitzpatrick Skin Types V and VI
NCT07918443, Not applicable, Not yet recruiting, Croma-Pharma GmbH
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Post-Approval Study of Saypha® ChIQ™ for Midface Augmentation in Subjects With Fitzpatrick Skin Types V and VI | ClinicalTrials.gov |
| NCT number | NCT07918443 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 45 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Croma-Pharma GmbH | ClinicalTrials.gov |
| Conditions | Moderate to Severe Midface Volume Deficit | ClinicalTrials.gov |
| Interventions | Crosslinked hyaluronic acid dermal filler with lidocaine | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of treatment-emergent adverse events (TEAEs) | Baseline through Week 24 after the last injection | Incidence and nature of treatment-emergent adverse events, including adverse device effects, serious adverse events, injection site reactions, symptoms of interest, ocular safety findings, and device deficiencies following treatment with saypha® ChIQ™. | ClinicalTrials.gov |
| Secondary | Injection site reactions | Through 4 weeks after each treatment | Injection site reactions recorded in subject diaries during the first 4 weeks (28 days) after each treatment, assessed overall and separately for the left and right side of the midface. | ClinicalTrials.gov |
| Secondary | Subject-reported pain | Immediately after treatment through 60 minutes after each treatment | Pain following each treatment assessed using the 11-point Numeric Pain Rating Scale (NPRS). | ClinicalTrials.gov |
| Secondary | Responder status on the 5-point Midface Volume Deficit Severity Scale (MVDSS) based on the evaluating investigator's live assessment | Weeks 4, 8, 16 and 24 after the last injection | Participants are defined as responders if they demonstrate an improvement of ≥1 point from baseline on the 5-point Midface Volume Deficit Severity Scale (MVDSS). | ClinicalTrials.gov |
| Secondary | Responder status on the 5-point Midface Volume Deficit Severity Scale (MVDSS) based on independent photographic reviewers' assessment | Weeks 4, 8, 16, and 24 after the last injection | Participants are defined as responders if they demonstrate an improvement of ≥1 point from baseline on the 5-point Midface Volume Deficit Severity Scale (MVDSS), based on the assessment of standardized photographs by independent photographic reviewers. | ClinicalTrials.gov |
| Secondary | Change from baseline in midface volume deficit measured by the 5-point Midface Volume Deficit Severity Scale (MVDSS), based on the evaluating investigator's live assessment | Weeks 4, 8, 16, and 24 after the last injection | Change from baseline in the 5-point Midface Volume Deficit Severity Scale (MVDSS) score, as assessed by the evaluating investigator during live evaluation. Lower MVDSS scores indicate less severe midface volume deficit. | ClinicalTrials.gov |
| Secondary | Global aesthetic improvement based on the 5-point modified Global Aesthetic Improvement Scale (mGAIS) | Weeks 4, 8, 16, and 24 after the last injection | Global aesthetic improvement based on the subject's and evaluating investigator's assessment. Participants rated as "Improved" or "Much Improved" will be considered responders. | ClinicalTrials.gov |
| Secondary | Subject satisfaction with treatment outcome and appearance based on the FACE-Q™ "Satisfaction with Outcome" and "Satisfaction with Cheeks" questionnaires | Weeks 4, 8, 16, and 24 after the last injection | Subject-reported satisfaction with the overall treatment outcome and satisfaction with the appearance of the cheeks, assessed using the validated FACE-Q™ "Satisfaction with Outcome" and "Satisfaction with Cheeks" questionnaires. | ClinicalTrials.gov |
| Secondary | Injection volume required to achieve optimal aesthetic correction | Day 1 (initial treatment) and Week 2 (optional touch-up treatment) | Total injection volume of saypha® ChIQ™ administered to achieve optimal aesthetic correction during the initial treatment and, if applicable, the optional touch-up treatment | ClinicalTrials.gov |
| Secondary | Change from baseline in nasolabial fold severity measured by the Nasolabial Fold Severity Rating Scale (NLF-SRS) based on the evaluating investigator's live assessment | Weeks 4, 8, 16, and 24 after the last injection | Change from baseline in nasolabial fold severity, as assessed by the evaluating investigator using the 5-point Nasolabial Fold Severity Rating Scale (NLF-SRS). Lower NLF-SRS scores indicate less severe nasolabial folds. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)