Topical GHK-Cu Gel for Acute Skin Wound Healing

NCT07437586 | Recruiting Phase 2 DMC

• 1 other identifier: GCU-WH-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Standardized Cutaneous Wounds (Punch-biopsy Wounds)

Keywords

GHK-Cu; copper peptide; Copper(II)-peptide complex; copper tripeptide-1; wound healing; re-epithelialization; skin repair; scar quality

Outcome Measures

Primary Outcomes (1)

• Time to complete re-epithelialization (days) of each wound, defined as 100% epithelial coverage without drainage, confirmed by blinded clinical assessment and standardized photography.

  21 Days

Secondary Outcomes (7)

• Percent wound area reduction

  1 Day

• Proportion of wounds healed

  21 Days

• Incidence of suspected or confirmed wound infection

  21 Days

• Participant-reported wound pain

  14 Days

• Local tolerability score

  12 weeks

Study Arms (2)

Arm A: GHK-Cu Gel (0.1% w/w) applied once daily to the assigned wound for 14 days + standard non-adh

EXPERIMENTAL

Drug: GHK-Cu Gel (Copper(II)-peptide complex); Drug: vehicle Gel (placebo comparator)

Arm B: Vehicle Gel applied once daily to the assigned wound for 14 days + standard non-adherent dres

EXPERIMENTAL

Drug: GHK-Cu Gel (Copper(II)-peptide complex); Drug: vehicle Gel (placebo comparator)

Interventions

GHK-Cu Gel (Copper(II)-peptide complex) DRUG

topical gel, 0.1% w/w; apply a thin film (approx. 0.5 g) once daily for 14 days.

Arm A: GHK-Cu Gel (0.1% w/w) applied once daily to the assigned wound for 14 days + standard non-adh; Arm B: Vehicle Gel applied once daily to the assigned wound for 14 days + standard non-adherent dres

vehicle Gel (placebo comparator) DRUG

ehicle Gel (placebo comparator

Arm A: GHK-Cu Gel (0.1% w/w) applied once daily to the assigned wound for 14 days + standard non-adh; Arm B: Vehicle Gel applied once daily to the assigned wound for 14 days + standard non-adherent dres

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hudson Biotech: lead

Study Sites (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

RECRUITING

Central Study Contacts

Seni S Lu, Phd

CONTACT

+86 13076790030; Seni-Lu@beijing-biotech.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: GHK-Cu and vehicle gels are identical in appearance, packaging, and labeling. Randomization codes are held by an independent pharmacist/biostatistician. Blinded assessors evaluate standardized photographs.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each participant receives two standardized wounds; one wound is randomized to GHK-Cu gel and the other to vehicle gel. This paired design controls for participant-level factors (e.g., age, genetics) that influence healing.

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: February 27, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): March 17, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CN (1)