治験レーダーAI | ||
|---|---|---|
治験 NCT07437586 (CuHeal)（対象：Acute Standardized Cutaneous Wounds (Punch-biopsy Wounds)）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Topical GHK-Cu Gel for Acute Skin Wound Healing (CuHeal) 第II相・フェーズ2 60
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07437586 (CuHeal) は Acute Standardized Cutaneous Wounds (Punch-biopsy Wounds) に関する 治療 の研究で、第II相・フェーズ2 介入研究 臨床試験 です。現在は 募集中 で、2026年2月2日 から開始しています。60 名の参加者 の募集が計画されています。この試験は Hudson Biotech によって主導され、2028年3月17日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年2月27日 です。
概要
This study will evaluate whether a topical gel containing GHK-Cu (a copper(II)-peptide complex) can safely speed up healing of small, standardized skin wounds in healthy adults compared with a matching vehicle gel.
Participants will receive two small punch-biopsy wounds on the upper arm; each wound will be randomly assigned to receive GHK-Cu gel or vehicle gel under identical dressings. Wounds will be photographed a...
もっと見る詳細説明
GHK (glycyl-L-histidyl-L-lysine) is a naturally occurring human peptide that can form a stable complex with copper(II) (GHK-Cu). Preclinical and mechanistic literature suggests GHK-Cu may influence processes relevant to tissue repair such as extracellular matrix remodeling, angiogenesis, and inflammation. This proof-of-concept study uses a standardized acute wound model (paired punch-biopsy wounds) to reduce variabil...もっと見る
公式タイトル
A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Split-Wound Study of Topical GHK-Cu (Copper(II)-Peptide Complex) Gel to Accelerate Re-Epithelialization of Standardized Acute Skin Wounds in Healthy Adults
疾患名
Acute Standardized Cutaneous Wounds (Punch-biopsy Wounds)その他の研究識別子
- CuHeal
- GCU-WH-001
NCT番号
開始日
2026-02-02
最終更新日
2026-02-27
終了予定日
2028-03-17
目標参加者数
60
試験の種類
介入研究
治験の相・段階
第II相・フェーズ2
状況
募集中
キーワード
GHK-Cu
copper peptide
Copper(II)-peptide complex
copper tripeptide-1
wound healing
re-epithelialization
skin repair
scar quality
copper peptide
Copper(II)-peptide complex
copper tripeptide-1
wound healing
re-epithelialization
skin repair
scar quality
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
四重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Arm A: GHK-Cu Gel (0.1% w/w) applied once daily to the assigned wound for 14 days + standard non-adh | GHK-Cu Gel (Copper(II)-peptide complex) topical gel, 0.1% w/w; apply a thin film (approx. 0.5 g) once daily for 14 days. vehicle Gel (placebo comparator) ehicle Gel (placebo comparator |
実験的Arm B: Vehicle Gel applied once daily to the assigned wound for 14 days + standard non-adherent dres | GHK-Cu Gel (Copper(II)-peptide complex) topical gel, 0.1% w/w; apply a thin film (approx. 0.5 g) once daily for 14 days. vehicle Gel (placebo comparator) ehicle Gel (placebo comparator |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Time to complete re-epithelialization (days) of each wound, defined as 100% epithelial coverage without drainage, confirmed by blinded clinical assessment and standardized photography. | 21 Days |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Percent wound area reduction | Assessed by digital planimetry from standardized photographs. | 1 Day |
Proportion of wounds healed | Binary outcomes derived from re-epithelialization assessment. | 21 Days |
Incidence of suspected or confirmed wound infection | Assessed clinically; swab/culture if clinically indicated | 21 Days |
Participant-reported wound pain | 0-10 numeric rating scale recorded daily | 14 Days |
Local tolerability score | Erythema, burning/stinging, pruritus scored at each visit. | 12 weeks |
Scar quality (POSAS) | Patient and Observer Scar Assessment Scale | 12 Weeks |
Safety | Treatment-emergent adverse events (local/systemic), serious adverse events, and withdrawals due to adverse events. | 14 days |
参加アシスタント
適格基準
対象年齢
成人
試験の最低年齢
18 Years
対象性別
全て
健康なボランティアを受け入れる
はい
- Age 18 to 55 years at screening.
- Healthy adult as determined by medical history and limited physical examination.
- Body mass index (BMI) 18.0 to 30.0 kg/m².
- Willing and able to comply with study visits and daily product application for 14 days.
- Willing to avoid applying non-study topical products (including medicated creams, retinoids, acids) to the wound area during the study period.
- For participants of childbearing potential: negative pregnancy test at screening and agreement to use effective contraception through Day 21.
- Known allergy or sensitivity to copper, peptides, gel excipients, adhesives, or dressings used in the study.
- History of abnormal wound healing, hypertrophic scarring, or keloid formation.
- Clinically significant dermatologic disease near the intended wound site (e.g., eczema, psoriasis, active infection).
- Diabetes mellitus, peripheral vascular disease, immunodeficiency, or other condition that may impair wound healing (investigator judgment).
- Use of systemic corticosteroids, immunosuppressants, or cytotoxic medications within 30 days prior to Day 0.
- Current smoker or nicotine use (including vaping) within the past 3 months.
- Pregnant or breastfeeding.
- Participation in another interventional clinical study within 30 days prior to screening.
- Any condition that, in the investigator's opinion, would make participation unsafe or could interfere with study assessments.
Hudson Biotech試験中央連絡先
連絡先: Seni S Lu, Phd, +86 13076790030, [email protected]
1 1カ国の場所
Guangdong
Peking University Shenzhen Hospital, Shenzhen, Guangdong, 518036, China
Zhen J Peng, Phd, 連絡先, +86 13076790039, [email protected]
募集中