Efficacy and Safety of HA35 Gel Nighttime Occlusive Application for TMD Pain (HA35-TMJ)
A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate Efficacy and Safety of Nighttime Occlusive 10% 35 kDa Hyaluronan (HA35) Gel for Temporomandibular Joint Disorder (TMD) Pain and Muscle Over-Tension
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 efficacy and safety of nighttime occlusive topical 10% high-concentration 35 kDa hyaluronan (HA35) gel for relieving pain and muscle over-tension associated with temporomandibular joint disorder (TMD).
Eligible subjects will apply ≥6.5 mL of HA35 gel to the TMJ region before sleep, covered with an occlusive film for 8-12 hours overnight. Pain intensity and muscle over-tension will be assessed using a 0-10 Numeric Rating Scale (NRS) at baseline, 60 seconds after application, and 12 hours after application.
Local skin reactions, adverse events, and overall tolerability will be monitored continuously.
This is a non-invasive, non-pharmacological 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
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age 18-60 years, male or female
- Clinically diagnosed with TMD with TMJ pain and/or muscle over-tension
- Baseline TMJ pain NRS score ≥3
- History of bruxism or jaw clenching
- Ability to complete NRS assessments independently
- Signed written informed consent
Exclusion Criteria:
- TMJ treatment (medication, physical therapy, injection) within 2 weeks
- Topical analgesic/anti-inflammatory use within 24 hours
- Skin damage, allergy, or infection in the TMJ application area
- Severe systemic disease (cardiovascular, diabetes, autoimmune)
- Known hypersensitivity to hyaluronan or gel components
- 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 |
|---|---|
|
実験的：HA35 Gel Nighttime Occlusive Application Group
Participants receive 10% high-concentration 35 kDa HA35 gel applied to the TMJ area nightly under occlusive conditions for 8-12 hours.
Efficacy on TMJ pain, muscle over-tension, and safety will be evaluated.
|
Topical gel containing 10% high-concentration 35 kDa hyaluronan fragment.
Applied to the TMJ area under nighttime occlusive conditions to rapidly relieve TMD-related pain and muscle over-tension.
他の名前：
|
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 TMJ Pain NRS Score (0-10)
時間枠：Baseline to 60 seconds and 12 hours after application
|
Change in TMD-related TMJ pain intensity measured by 0-10 NRS, 0 = no pain, 10 = worst imaginable pain.
|
Baseline to 60 seconds and 12 hours after application
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Jaw Muscle Over-Tension Intensity (0-10 NRS Score)
時間枠：Baseline to 60 seconds and 12 hours after application
|
Change in jaw muscle over-tension intensity, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no muscle tension and 10 = maximum, painful muscle over-tension.
|
Baseline to 60 seconds and 12 hours after application
|
|
Incidence and Severity of Local Skin Adverse Events
時間枠：From study enrollment (baseline) to the end of the 12-hour observation period
|
Number and severity of treatment-related local skin adverse events (e.g., redness, irritation, allergic reaction) reported during the study.
Severity is graded using the Common Terminology Criteria for Adverse Events (CTCAE).
|
From study enrollment (baseline) to the end of the 12-hour observation period
|
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
- HA35202605
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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