Topical GHK-Cu Gel for Acute Skin Wound Healing (CuHeal)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Standardized Cutaneous Wounds (Punch-biopsy Wounds)
• Intervention / Treatment: Drug: GHK-Cu Gel (Copper(II)-peptide complex); Drug: vehicle Gel (placebo comparator)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Seni S Lu, Phd; Phone Number: +86 13076790030; Email: Seni-Lu@beijing-biotech.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518036
      • Recruiting
      • Peking University Shenzhen Hospital
      • Contact: Zhen J Peng, Phd; Phone Number: +86 13076790039; Email: Zhen-Peng@beijing-biotech.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: GHK-Cu Gel (0.1% w/w) applied once daily to the assigned wound for 14 days + standard non-adh	Drug: 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.; Drug: vehicle Gel (placebo comparator); ehicle Gel (placebo comparator
Experimental: Arm B: Vehicle Gel applied once daily to the assigned wound for 14 days + standard non-adherent dres	Drug: 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.; Drug: vehicle Gel (placebo comparator); ehicle Gel (placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hudson Biotech

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2026
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): March 17, 2028

Study Registration Dates

• First Submitted: February 22, 2026
• First Submitted That Met QC Criteria: February 22, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: wound healing; scar quality; re-epithelialization; GHK-Cu; copper peptide; Copper(II)-peptide complex; copper tripeptide-1; skin repair
• Other Study ID Numbers: GCU-WH-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No