Moderate to Severe Midface Volume DeficitVolido PASNCT07918443
Post-Approval Study of Saypha® ChIQ™ for Midface Augmentation in Subjects With Fitzpatrick Skin Types V and VI
A study testing Crosslinked hyaluronic acid dermal filler with lidocaine in people with Moderate to Severe Midface Volume Deficit, run by Croma-Pharma GmbH.
Trial summary
The goal of this clinical trial is to further characterize the safety profile of saypha® ChIQ™ for midface augmentation in adults with Fitzpatrick Skin Types V and VI who have moderate to severe midface volume deficit. Read more about this study
- Who is it for?
- Ages 22 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate to Severe Midface Volume Deficit
- What is being tested?
- Crosslinked hyaluronic acid dermal filler with lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, 22 to 75 years of age.
- Fitzpatrick Skin Type V or VI, as assessed by the investigator and confirmed by a central reviewer.
- Bilateral, approximately symmetric moderate to severe midface volume deficit (score of 2 or 3 on the 5-point Midface Volume Deficit Severity Scale [MVDSS]).
- Females of childbearing potential must have a negative urine pregnancy test and agree to use effective contraception throughout the study. Male participants with female partners of childbearing potential must agree to use effective contraception throughout the study.
- Healthy skin in the treatment area without conditions that could interfere with study assessments.
- Willing to refrain from aesthetic or surgical procedures in the treatment area during the study, except botulinum toxin treatment of the glabella or forehead.
- Able to understand the study, provide written informed consent, and comply with study procedures and visits.
Who cannot join
- Pregnant, breastfeeding, or planning to become pregnant during the study.
- History of severe allergy, anaphylaxis, or multiple severe allergies.
- Known allergy or hypersensitivity to hyaluronic acid, gram-positive bacterial proteins, lidocaine, or amide-type local anesthetics.
- History of keloid formation, hypertrophic scarring, or pigment disorders.
- Known human immunodeficiency virus (HIV) infection.
- Infectious, inflammatory, malignant, or premalignant lesions in the treatment area.
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- Recurrent herpes simplex in the treatment area (three or more episodes during the previous year).
- Autoimmune or connective tissue disease, or current immunomodulatory therapy.
- Uncontrolled diabetes mellitus or other uncontrolled systemic disease considered unsuitable by the investigator.
- Previous facial plastic surgery or treatment with permanent or long-lasting fillers in the treatment area.
- Dermal filler treatment in the treatment area within 24 months before screening or planned during the study.
- Aesthetic procedures in the midface area (e.g., laser therapy, threads, dermabrasion, mesotherapy, microneedling, or botulinum toxin) within 12 months before screening or planned during the study.
- Chemical peel in the treatment area within 3 months before screening or planned during the study.
- Facial lipolysis, including submental fat treatment, within 12 months before screening or planned during the study.
- Bariatric surgery within 12 months before screening or planned during the study.
- Bleeding disorder or use of anticoagulants, antiplatelet agents, thrombolytics, corticosteroids, nonsteroidal anti-inflammatory drugs, or other substances known to increase bleeding risk during the protocol-defined restricted period around treatment.
- Planned dental or oral surgery within 4 weeks before or after study treatment.
- Facial hair that may interfere with study assessments.
- Abnormal baseline visual examination (visual acuity worse than 20/40 with correction, abnormal visual field, or abnormal ocular motility).
- Clinically significant active infection within 14 days before screening.
- Any medical condition that, in the investigator's opinion, makes participation unsuitable.
- Previous participation in this clinical investigation or the pivotal VOLIDO study.
- Participation in another clinical trial or treatment with an investigational drug or medical device within 30 days before screening.
- Midface volume deficit caused by congenital abnormalities, trauma, or abnormal facial fat distribution.
- Weight loss of ≥10% during the previous 12 months or planned lifestyle changes expected to result in weight gain or weight loss of more than 10% during the study.
- Individuals whose decision to participate may be subject to undue influence or coercion.
- Employees of the sponsor or individuals with a close affiliation to the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective, Multicenter, Open-Label, Single-Arm Post-Approval Study to Further Characterize the Safety Profile of Saypha® ChIQ™ for Midface Augmentation in Subjects With Fitzpatrick Skin Types V and VI
The goal of this clinical trial is to further characterize the safety profile of saypha® ChIQ™ for midface augmentation in adults with Fitzpatrick Skin Types V and VI who have moderate to severe midface volume deficit.
The main questions it aims to answer are whether treatment with saypha® ChIQ™ has an acceptable safety profile, as assessed by the incidence and nature of treatment-emergent adverse events, including adverse device effects, injection site reactions, symptoms of interest, and ocular safety findings through 24 weeks after the last injection, and whether treatment improves midface volume deficit and subject-reported aesthetic outcomes in this study population.
Participants will receive treatment with saypha® ChIQ™ at baseline, with an optional touch-up treatment approximately 2 weeks later if clinically indicated, attend scheduled follow-up visits for safety and effectiveness assessments for up to 24 weeks after the last injection; and complete subject-reported outcome assessments and safety diaries as specified in the protocol.
Read the detailed description
saypha® ChIQ™ is an FDA-approved hyaluronic acid dermal filler indicated for cheek augmentation to correct midface volume deficit in adults. In the pivotal clinical study supporting approval, enrollment of subjects with Fitzpatrick Skin Types (FST) V and VI was below the targeted representation. Therefore, this post-approval study is being conducted in response to an FDA post-approval requirement to further characterize the safety profile of saypha® ChIQ™ in this population.
This is a prospective, multicenter, open-label, single-arm post-approval clinical trial conducted in the US. Approximately 45 adults with Fitzpatrick Skin Types V and VI and moderate to severe midface volume deficit will be enrolled and followed for 24 weeks after the last injection. The study will collect additional safety data in this underrepresented population while also evaluating treatment effectiveness using validated clinician- and subject-reported outcome measures.
- Being tested
- Crosslinked hyaluronic acid dermal filler with lidocaine
- Keywords
- Midface Augmentation, Hyaluronic Acid Dermal Filler, saypha® ChIQ™, Fitzpatrick Skin Type V and VI, Medical Device, Post-Approval Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crosslinked hyaluronic acid dermal filler with lidocaineDevice
saypha® ChIQ™ is an FDA-approved crosslinked hyaluronic acid dermal filler containing 23 mg/mL hyaluronic acid and 0.3% lidocaine hydrochloride. The device is administered by subcutaneous and/or supraperiosteal injection for correction of moderate to severe midface volume deficit. An optional touch-up treatment may be administered approximately 2 weeks after the initial treatment if clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| saypha® ChIQ™ | Experimental | Participants receive treatment with saypha® ChIQ™ for correction of moderate to severe midface volume deficit. An optional touch-up treatment may be administered approximately 2 weeks after the initial treatment if clinically indicated. Receives: Device: Crosslinked hyaluronic acid dermal filler with lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
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™.
Measured: Baseline through Week 24 after the last injection
Secondary outcomes (9)
Injection site reactions
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.
Measured: Through 4 weeks after each treatment
Subject-reported pain
Pain following each treatment assessed using the 11-point Numeric Pain Rating Scale (NPRS).
Measured: Immediately after treatment through 60 minutes after each treatment
Responder status on the 5-point Midface Volume Deficit Severity Scale (MVDSS) based on the evaluating investigator's live assessment
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).
Measured: Weeks 4, 8, 16 and 24 after the last injection
Responder status on the 5-point Midface Volume Deficit Severity Scale (MVDSS) based on independent photographic reviewers' assessment
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.
Measured: Weeks 4, 8, 16, and 24 after the last injection
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
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.
Measured: Weeks 4, 8, 16, and 24 after the last injection
Global aesthetic improvement based on the 5-point modified Global Aesthetic Improvement Scale (mGAIS)
Global aesthetic improvement based on the subject's and evaluating investigator's assessment. Participants rated as "Improved" or "Much Improved" will be considered responders.
Measured: Weeks 4, 8, 16, and 24 after the last injection
Subject satisfaction with treatment outcome and appearance based on the FACE-Q™ "Satisfaction with Outcome" and "Satisfaction with Cheeks" questionnaires
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.
Measured: Weeks 4, 8, 16, and 24 after the last injection
Injection volume required to achieve optimal aesthetic correction
Total injection volume of saypha® ChIQ™ administered to achieve optimal aesthetic correction during the initial treatment and, if applicable, the optional touch-up treatment
Measured: Day 1 (initial treatment) and Week 2 (optional touch-up treatment)
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
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.
Measured: Weeks 4, 8, 16, and 24 after the last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study startJan 2027 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Midface Volume DeficitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Croma-Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918443
- Sponsor's protocol ID
- CPH-10601
- Acronym
- Volido PAS
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Open-Label, Single-Arm Post-Approval Study to Further Characterize the Safety Profile of Saypha® ChIQ™ for Midface Augmentation in Subjects With Fitzpatrick Skin Types V and VI
- ClinicalTrials.gov ID
- NCT07918443
- Acronym / sponsor ID
- Volido PAS / CPH-10601
- Keywords
- Midface Augmentation, Hyaluronic Acid Dermal Filler, saypha® ChIQ™, Fitzpatrick Skin Type V and VI, Medical Device, Post-Approval Study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Croma-Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to further characterize the safety profile of saypha® ChIQ™ for midface augmentation in adults with Fitzpatrick Skin Types V and VI who have moderate to severe midface volume deficit.
The main questions it aims to answer are whether treatment with saypha® ChIQ™ has an acceptable safety profile, as assessed by the incidence and nature of treatment-emergent adverse events, including adverse device effects, injection site reactions, symptoms of interest, and ocular safety findings through 24 weeks after the last injection, and whether treatment improves midface volume deficit and subject-reported aesthetic outcomes in this study population.
Participants will receive treatment with saypha® ChIQ™ at baseline, with an optional touch-up treatment approximately 2 weeks later if clinically indicated, attend scheduled follow-up visits for safety and effectiveness assessments for up to 24 weeks after the last injection; and complete subject-reported outcome assessments and safety diaries as specified in the protocol.
Detailed description
saypha® ChIQ™ is an FDA-approved hyaluronic acid dermal filler indicated for cheek augmentation to correct midface volume deficit in adults. In the pivotal clinical study supporting approval, enrollment of subjects with Fitzpatrick Skin Types (FST) V and VI was below the targeted representation. Therefore, this post-approval study is being conducted in response to an FDA post-approval requirement to further characterize the safety profile of saypha® ChIQ™ in this population.
This is a prospective, multicenter, open-label, single-arm post-approval clinical trial conducted in the US. Approximately 45 adults with Fitzpatrick Skin Types V and VI and moderate to severe midface volume deficit will be enrolled and followed for 24 weeks after the last injection. The study will collect additional safety data in this underrepresented population while also evaluating treatment effectiveness using validated clinician- and subject-reported outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| saypha® ChIQ™ | Experimental | Device: Crosslinked hyaluronic acid dermal filler with lidocaineParticipants receive treatment with saypha® ChIQ™ for correction of moderate to severe midface volume deficit. An optional touch-up treatment may be administered approximately 2 weeks after the initial treatment if clinically indicated. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, 22 to 75 years of age.
- Fitzpatrick Skin Type V or VI, as assessed by the investigator and confirmed by a central reviewer.
- Bilateral, approximately symmetric moderate to severe midface volume deficit (score of 2 or 3 on the 5-point Midface Volume Deficit Severity Scale [MVDSS]).
- Females of childbearing potential must have a negative urine pregnancy test and agree to use effective contraception throughout the study. Male participants with female partners of childbearing potential must agree to use effective contraception throughout the study.
- Healthy skin in the treatment area without conditions that could interfere with study assessments.
Key exclusion criteria (27 listed)
- Pregnant, breastfeeding, or planning to become pregnant during the study.
- History of severe allergy, anaphylaxis, or multiple severe allergies.
- Known allergy or hypersensitivity to hyaluronic acid, gram-positive bacterial proteins, lidocaine, or amide-type local anesthetics.
- History of keloid formation, hypertrophic scarring, or pigment disorders.
- Known human immunodeficiency virus (HIV) infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crosslinked hyaluronic acid dermal filler with lidocainesaypha® ChIQ™ is an FDA-approved crosslinked hyaluronic acid dermal filler containing 23 mg/mL hyaluronic acid and 0.3% lidocaine hydrochloride. The device is administered by subcutaneous and/or supraperiosteal injection for correction of moderate to severe midface volume deficit. An optional touch-up treatment may be administered approximately 2 weeks after the initial treatment if clinically indicated. | Device | saypha® ChIQ™ |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: 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™.
9 secondary outcomes
Injection site reactions
Time frame: Through 4 weeks after each treatment
Subject-reported pain
Time frame: Immediately after treatment through 60 minutes after each treatment
Responder status on the 5-point Midface Volume Deficit Severity Scale (MVDSS) based on the evaluating investigator's live assessment
Time frame: Weeks 4, 8, 16 and 24 after the last injection
Responder status on the 5-point Midface Volume Deficit Severity Scale (MVDSS) based on independent photographic reviewers' assessment
Time frame: Weeks 4, 8, 16, and 24 after the last injection
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
Time frame: Weeks 4, 8, 16, and 24 after the last injection
Global aesthetic improvement based on the 5-point modified Global Aesthetic Improvement Scale (mGAIS)
Time frame: Weeks 4, 8, 16, and 24 after the last injection
Subject satisfaction with treatment outcome and appearance based on the FACE-Q™ "Satisfaction with Outcome" and "Satisfaction with Cheeks" questionnaires
Time frame: Weeks 4, 8, 16, and 24 after the last injection
Injection volume required to achieve optimal aesthetic correction
Time frame: Day 1 (initial treatment) and Week 2 (optional touch-up treatment)
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
Time frame: Weeks 4, 8, 16, and 24 after the last injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Crosslinked hyaluronic acid dermal filler with lidocaine in people with Moderate to Severe Midface Volume Deficit, run by Croma-Pharma GmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Head of Clinical Operation (+43 2262 684 68 0, clinical.studies@croma.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) (time frame: Baseline through Week 24 after the last injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.