Health TrialsbyHealthPanel

Topical GHK-Cu Gel for Acute Skin Wound Healing

ConditionAcute Standardized Cutaneous Wounds (Punch-biopsy Wounds)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorHudson Biotech

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • vehicle Gel (placebo comparator)

    Drug

    ehicle Gel (placebo comparator

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Arm A: GHK-Cu Gel (0.1% w/w) applied once daily to the assigned wound for 14 days + standard non-adhExperimental treatment 2 interventions
Group B: Arm B: Vehicle Gel applied once daily to the assigned wound for 14 days + standard non-adherent dresExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
21 Days

Secondary outcomes

1

Percent wound area reduction

Assessed by digital planimetry from standardized photographs.

Time frame
1 Day
2

Proportion of wounds healed

Binary outcomes derived from re-epithelialization assessment.

Time frame
21 Days
3

Incidence of suspected or confirmed wound infection

Assessed clinically; swab/culture if clinically indicated

Time frame
21 Days
4

Participant-reported wound pain

0-10 numeric rating scale recorded daily

Time frame
14 Days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hudson Biotech

Lead sponsor

Source ClinicalTrials.gov
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