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

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.