Post-Approval Study of Saypha® ChIQ™ for Midface Augmentation in Subjects With Fitzpatrick Skin Types V and VI (Volido PAS)

October 31, 2026 updated by: Croma-Pharma GmbH

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: saypha® ChIQ™

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.
Device: Crosslinked hyaluronic acid dermal filler with lidocaine

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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™.
Baseline through Week 24 after the last injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Injection site reactions
Time Frame: 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.
Through 4 weeks after each treatment
Subject-reported pain
Time Frame: Immediately after treatment through 60 minutes after each treatment

Pain following each treatment assessed using the 11-point Numeric Pain Rating Scale (NPRS).
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

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).
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

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.
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

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.
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

Global aesthetic improvement based on the subject's and evaluating investigator's assessment. Participants rated as "Improved" or "Much Improved" will be considered responders.
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

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.
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)

Total injection volume of saypha® ChIQ™ administered to achieve optimal aesthetic correction during the initial treatment and, if applicable, the optional touch-up treatment
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

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.
Weeks 4, 8, 16, and 24 after the last injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Croma-Pharma GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CPH-10601

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings