Post-Approval Study of Saypha® ChIQ™ for Midface Augmentation in Subjects With Fitzpatrick Skin Types V and VI (Volido PAS)
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Head of Clinical Operation
- 電話番号：+43 2262 684 68 0
- メール：clinical.studies@croma.at
研究連絡先のバックアップ
- 名前：Clinical Project Manager
- 電話番号：+43 2262 684 68 0
- メール：clinical.studies@croma.at
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of treatment-emergent adverse events (TEAEs)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Injection site reactions
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- CPH-10601
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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