NCT07437586

Topical GHK-Cu Gel for Acute Skin Wound Healing

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hudson Biotech · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Acute Standardized Cutaneous Wounds (Punch-biopsy Wounds)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-02-02
• Primary completion: 2027-02-14
• Completion: 2028-03-17
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: China