Topical GHK-Cu gel to speed healing of small skin wounds

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 test will see if applying a daily GHK‑Cu gel helps small punch‑biopsy skin wounds heal faster in healthy adults.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Hudson Biotech (Industry-sponsored)
• Locations: 1 site (Shenzhen, Guangdong)
• Trial ID: NCT07437586 on ClinicalTrials.gov

What this trial studies

This randomized, paired wound proof‑of‑concept study creates two 5‑mm punch‑biopsy wounds on the non‑dominant upper arm of healthy adults and randomizes each wound to receive either topical GHK‑Cu gel or a matching vehicle gel. Study product is applied once daily under standardized non‑adherent dressings for 14 days, with in‑clinic assessments and standardized photography on Days 3, 7, 10, 14, and 21 (or until healed). The primary outcome is time to complete re‑epithelialization, with secondary outcomes including wound area reduction over time, local symptoms (pain/itch), infection rate, scar quality at 12 weeks (POSAS), and safety/tolerability. This paired design reduces inter‑subject variability to provide a controlled comparison between active and vehicle treatments.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18–55 with BMI 18.0–30.0 kg/m² who can attend study visits and agree to have two 5‑mm punch biopsies on the upper arm and apply the gel daily for 14 days.

Not a fit: People with diabetes, peripheral vascular disease, immunodeficiency, significant dermatologic disease near the wound, a history of hypertrophic scarring or keloids, or known allergy to copper/peptide excipients are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the gel could shorten healing time for small skin wounds and improve early wound closure with minimal systemic exposure.

How similar studies have performed: Preclinical and mechanistic studies suggest GHK‑Cu can influence extracellular matrix remodeling, angiogenesis, and inflammation, but randomized controlled human wound trials are limited, so this is an early proof‑of‑concept in people.

Eligibility criteria

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.

Where this trial is running

Shenzhen, Guangdong

• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Seni S Lu, Phd

Conditions Acute Standardized Cutaneous Wounds; GHK-Cu; copper peptide; Copper-peptide complex; copper tripeptide-1; wound healing; re-epithelialization; skin repair