Efficacy and Safety of Overnight Occlusive HA35 Gel for Facial Aesthetic Improvement (HA35-FACIAL)
A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate Efficacy and Safety of Overnight Occlusive Topical 10% 35 kDa Hyaluronan (HA35) Gel for Facial Subcutaneous Fat Appearance, Erythema, Skin Radiance, and Pore Condition
調査の概要
状態
条件
詳細な説明
This prospective, single-center, single-arm, open-label pilot clinical study investigates the efficacy and safety of overnight occlusive topical 10% high-concentration 35 kDa hyaluronan (HA35) gel for improving multiple facial aesthetic outcomes, including subcutaneous fat appearance, inflammatory erythema, skin radiance, and nasal alar pore condition.
Eligible subjects will apply HA35 gel to the entire face before sleep, covered with an occlusive film to retain moisture, and left in place overnight. The intervention will be administered once every 2 days for 5 applications over 10 days.
Outcomes will be assessed at baseline, after 1 application, and after 5 applications using a standardized 0-10 Numeric Rating Scale (NRS) for subcutaneous fat thickness, erythema severity, skin radiance, and pore enlargement. Local skin tolerability and adverse events will be monitored throughout the study.
This is a non-invasive, non-pharmacological aesthetic intervention with minimal risk. All procedures are conducted in accordance with the Declaration of Helsinki, and written informed consent is obtained from all subjects prior to enrollment.
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age 18-60 years, male or female
- Seeking non-invasive improvement of facial appearance
- Presenting with at least one of: facial subcutaneous fat accumulation, facial erythema, skin dullness, nasal alar pore enlargement
- Baseline NRS score ≥2 for at least one target parameter
- Ability to complete self-assessments
- Signed written informed consent
Exclusion Criteria:
- Facial aesthetic treatments (injection, laser, fat reduction, peeling) within 2 weeks
- Active facial dermatitis, infection, or open wounds
- Known hypersensitivity to hyaluronan or gel components
- Pregnant or lactating women
- Severe systemic disease or uncontrolled medical condition
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：支持療法
- 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：HA35 Overnight Occlusive Topical Gel Group
Participants receive 10% high-concentration 35 kDa HA35 gel as overnight occlusive topical application to the entire face, once every 2 days for 5 applications over 10 days.
Efficacy on facial fat, erythema, radiance, pores, and safety will be evaluated.
|
A topical, non-pharmacological facial gel containing 10% high-concentration 35 kDa hyaluronan fragment.
Applied under occlusive conditions overnight to improve facial subcutaneous fat appearance, reduce erythema, enhance radiance, and improve pore condition.
他の名前：
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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 |
|---|---|---|
|
Change in Facial Subcutaneous Fat Thickness NRS Score (0-10)
時間枠：Baseline to after 1 application and after 5 applications
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Change in facial subcutaneous fat thickness assessed by 0-10 NRS, 0 = normal, 10 = maximum thickness.
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Baseline to after 1 application and after 5 applications
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Facial Inflammatory Erythema Severity (0-10 NRS Score)
時間枠：Baseline (Day 0) to Day 2 and Day 10
|
Change in facial inflammatory erythema severity, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no redness and 10 = maximum facial redness and inflammation.
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Baseline (Day 0) to Day 2 and Day 10
|
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Change in Facial Skin Radiance (0-10 NRS Score)
時間枠：Baseline (Day 0) to Day 2 and Day 10
|
Change in perceived facial skin radiance and brightness, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = dull/lifeless skin and 10 = bright, glowing skin.
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Baseline (Day 0) to Day 2 and Day 10
|
|
Change in Nasal Alar Pore Enlargement Severity (0-10 NRS Score)
時間枠：Baseline (Day 0) to Day 2 and Day 10
|
Change in the severity of nasal alar pore enlargement, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no visible pores and 10 = maximum pore size and visibility.
|
Baseline (Day 0) to Day 2 and Day 10
|
|
Incidence and Severity of Local Skin Adverse Events
時間枠：Baseline (Day 0) to Day 2 and Day 10
|
Number and severity of treatment-related local skin adverse events (e.g., irritation, redness, allergic reaction) reported during the study.
Severity is graded using the Common Terminology Criteria for Adverse Events (CTCAE).
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Baseline (Day 0) to Day 2 and Day 10
|
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Incidence and Severity of Local Skin Adverse Events
時間枠：From Day 0 to Day 10
|
Number and severity of treatment-related local skin adverse events (e.g., irritation, redness, allergic reaction) reported during the study.
Severity is graded using the Common Terminology Criteria for Adverse Events (CTCAE).
|
From Day 0 to Day 10
|
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
- HA35202603
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
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