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RecruitingPhase 2NCT07437586

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

Sponsor

Hudson Biotech

Enrollment

60 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

Conditions

Acute Standardized Cutaneous Wounds (Punch-biopsy Wounds)

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.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria6

  • 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 Criteria9

  • 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.
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Interventions

DRUGGHK-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.

DRUGvehicle Gel (placebo comparator)

ehicle Gel (placebo comparator

Locations(1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

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NCT07437586