Efficacy and Safety of HA35 Gel for Ultra-Rapid Skin Pruritus Relief (HA35-ITCH)
A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate Efficacy and Safety of Topical 10% 35 kDa Hyaluronan (HA35) Gel for Ultra-Rapid Relief of Diverse Etiology Skin Pruritus
調査の概要
状態
詳細な説明
This prospective, single-center, single-arm, open-label pilot clinical study investigates the ultra-rapid antipruritic efficacy and safety of topical 10% high-concentration 35 kDa hyaluronan (HA35) gel for managing moderate-to-severe skin pruritus caused by various conditions including eczema, neurodermatitis, insect bites, urticaria, and postoperative wound pruritus.
Eligible subjects will receive a single topical application of HA35 gel evenly spread over the pruritic skin area. Pruritus intensity will be assessed using a 0-10 Numeric Rating Scale (NRS) at baseline, 10 seconds, 45 minutes, 8 hours, 12 hours, and 24 hours after application. Changes in associated erythema, swelling, and wheals will also be observed.
Local skin irritation, allergic reactions, and adverse events will be monitored continuously for safety assessment.
This is a non-invasive, non-pharmacological topical intervention with minimal risk to participants. All procedures will be conducted in accordance with the Declaration of Helsinki, and written informed consent will be 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
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age 18-65 years, male or female
- Moderate-to-severe skin pruritus (NRS ≥6) due to eczema, neurodermatitis, insect bites, urticaria, or postoperative wound itch
- Able to understand and complete NRS assessments independently
- Signed written informed consent
Exclusion Criteria:
- Topical corticosteroid/antihistamine use within 2 weeks
- Infected, broken, or exudative skin lesions at the application site
- Known hypersensitivity to hyaluronan or gel components
- Severe systemic disease or immune dysfunction
- Pregnant or lactating women
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 |
|---|---|
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実験的：HA35 Topical Gel Intervention Group
Participants receive a single topical application of 10% high-concentration 35 kDa HA35 gel to the pruritic skin area.
Efficacy on ultra-rapid pruritus relief, duration of effect, and safety will be evaluated.
|
Topical skin gel containing 10% high-concentration 35 kDa hyaluronan fragment.
Applied topically to pruritic areas to provide ultra-rapid relief of skin itching and improve associated inflammatory signs.
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 Skin Pruritus NRS Score (0-10)
時間枠：Baseline to 10 seconds, 45 minutes, 8 hours, 12 hours, and 24 hours after application
|
Change in pruritus intensity measured by 0-10 NRS, 0 = no itching, 10 = worst imaginable itching.
|
Baseline to 10 seconds, 45 minutes, 8 hours, 12 hours, and 24 hours after application
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Onset time of clinically significant pruritus relief
時間枠：Within 10 seconds after application
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Within 10 seconds after application
|
|
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Duration of pruritus relief
時間枠：Up to 24 hours
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Up to 24 hours
|
|
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Change in Skin Erythema Severity (0-10 NRS Score)
時間枠：Baseline to 45 minutes and 24 hours after application
|
Change in skin erythema severity at the application site, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no erythema and 10 = maximum redness.
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Baseline to 45 minutes and 24 hours after application
|
|
Change in Local Skin Swelling Severity (0-10 NRS Score)
時間枠：Baseline to 45 minutes and 24 hours after application
|
Change in local skin swelling severity at the application site, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no swelling and 10 = maximum swelling.
|
Baseline to 45 minutes and 24 hours after application
|
|
Change in Urticarial Wheal Severity (0-10 NRS Score)
時間枠：Baseline to 45 minutes and 24 hours after application
|
Change in urticarial wheal severity at the application site, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no wheals and 10 = maximum wheal size and spread.
|
Baseline to 45 minutes and 24 hours after application
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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
追加の関連 MeSH 用語
その他の研究ID番号
- HA35202608
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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