A Phase 2 interventional study of GHK-Cu Gel (Copper(II)-peptide complex) and vehicle Gel (placebo comparator) in Acute Standardized Cutaneous Wounds (Punch-biopsy Wounds), sponsored by Hudson Biotech. Recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Hudson Biotech · Phase 2, Interventional, and Treatment
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.
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.
Hudson Biotech is the lead sponsor of 8 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: GHK-Cu Gel (Copper(II)-peptide complex) · Drug: vehicle Gel (placebo comparator)
Drug: GHK-Cu Gel (Copper(II)-peptide complex) · Drug: vehicle Gel (placebo comparator)
topical gel, 0.1% w/w; apply a thin film (approx. 0.5 g) once daily for 14 days.
ehicle Gel (placebo comparator
Time to complete re-epithelialization (days) of each wound, defined as 100% epithelial coverage without drainage, confirmed by blinded clinical assessment and standardized photography.
Time frame: 21 Days
Percent wound area reduction
Assessed by digital planimetry from standardized photographs.
Time frame: 1 Day
Proportion of wounds healed
Binary outcomes derived from re-epithelialization assessment.
Time frame: 21 Days
Incidence of suspected or confirmed wound infection
Assessed clinically; swab/culture if clinically indicated
Time frame: 21 Days
Participant-reported wound pain
0-10 numeric rating scale recorded daily
Time frame: 14 Days
Local tolerability score
Erythema, burning/stinging, pruritus scored at each visit.
Time frame: 12 weeks
Scar quality (POSAS)
Patient and Observer Scar Assessment Scale
Time frame: 12 Weeks
Safety
Treatment-emergent adverse events (local/systemic), serious adverse events, and withdrawals due to adverse events.
Time frame: 14 days
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