Topical GHK-Cu gel to speed healing of small skin wounds
Official title: 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
Run by Hudson Biotech · NCT07437586 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Hudson Biotech Industry-sponsored |
| Locations | 1 site (Shenzhen, Guangdong) |
| Status | Recruiting |
| Started | February 2, 2026 |
| Main results expected | February 14, 2027 |
| Study ends | March 17, 2028 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT07437586 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Peking University Shenzhen Hospital
Shenzhen, Guangdong, China Recruiting
Study contacts
- Study coordinator: Seni S Lu, Phd
- Email: Seni-Lu@beijing-biotech.com
- Phone: +86 13076790030
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.