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Trial · Interventional

RecruitingPhase 2Registry data

Topical GHK-Cu Gel for Acute Skin Wound Healing

Short name CuHeal

NCTNCT07437586 (opens ClinicalTrials.gov in a new tab)Other idGCU-WH-001
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 2
Enrollment
60 participants (estimated)
Sponsor
Hudson Biotech · Industry
Design
Randomized · Quadruple masking
Countries
1 country

China

Start
2 Feb 2026
Primary completion
14 Feb 2027 (estimated)
Completion
17 Mar 2028 (estimated)
First posted
27 Feb 2026
Last update posted
27 Feb 2026
Conditions
Acute Standardized Cutaneous Wounds (Punch-biopsy Wounds)

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2026202720282029
  1. Ph 2

    CuHeal

    NCT07437586

    2 Feb 2026 to est. 17 Mar 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

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

Arms2

  • Experimental

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

  • Experimental

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  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.

    Time frame · 21 Days

Secondary outcomes(7)

  1. Percent wound area reduction

    Time frame · 1 Day

    Registry description

    Assessed by digital planimetry from standardized photographs.

  2. Proportion of wounds healed

    Time frame · 21 Days

    Registry description

    Binary outcomes derived from re-epithelialization assessment.

  3. Incidence of suspected or confirmed wound infection

    Time frame · 21 Days

    Registry description

    Assessed clinically; swab/culture if clinically indicated

  4. Participant-reported wound pain

    Time frame · 14 Days

    Registry description

    0-10 numeric rating scale recorded daily

  5. Local tolerability score

    Time frame · 12 weeks

    Registry description

    Erythema, burning/stinging, pruritus scored at each visit.

  6. Scar quality (POSAS)

    Time frame · 12 Weeks

    Registry description

    Patient and Observer Scar Assessment Scale

  7. Safety

    Time frame · 14 days

    Registry description

    Treatment-emergent adverse events (local/systemic), serious adverse events, and withdrawals due to adverse events.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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