Topical GHK-Cu Gel for Acute Skin Wound Healing

Официальное название

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

Обзор

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 and assessed over 3 weeks, with a follow-up visit to evaluate scar quality.

Подробное описание

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 variability and enable a controlled comparison. Study objectives Primary objective: Determine whether topical GHK-Cu gel reduces time to complete re-epithelialization versus vehicle. Secondary objectives: Evaluate wound area reduction over time, local symptoms (pain/itch), infection rate, scar quality at 12 weeks, and safety/tolerability. Study procedures (overview) Day 0: Two 5-mm punch-biopsy wounds will be created under local anesthetic on the non-dominant upper arm. Wounds will be randomized (1:1) to receive GHK-Cu gel or vehicle gel. Study products will be applied once daily for 14 days under standardized non-adherent dressings. Follow-up: In-clinic assessments with standardized digital photography and clinical evaluation on Days 3, 7, 10, 14, and 21 (or until healed). Remote check-ins may be used for interim safety and adherence.

Week 12: Scar assessment (POSAS) and final safety review.

Вмешательства

• Препарат 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.
• Препарат vehicle Gel (placebo comparator)
  ehicle Gel (placebo comparator

Первичные конечные точки

• Time to complete re-epithelialization (days) of each wound, defined as 100% epithelial coverage without drainage, confirmed by blinded clinical assessment and standardized photography. [Срок оценки: 21 Days]

Вторичные конечные точки (7)

• Percent wound area reduction [Срок оценки: 1 Day]
• Proportion of wounds healed [Срок оценки: 21 Days]
• Incidence of suspected or confirmed wound infection [Срок оценки: 21 Days]
• Participant-reported wound pain [Срок оценки: 14 Days]
• Local tolerability score [Срок оценки: 12 weeks]
• Scar quality (POSAS) [Срок оценки: 12 Weeks]
• Safety [Срок оценки: 14 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University Shenzhen Hospital — Шэньчжэнь

Идентификаторы

NCT: NCT07437586 · GCU-WH-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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