Topical GHK-Cu Gel for Acute Skin Wound Healing (CuHeal)

Hudson Biotech

Status and phase

Enrolling

Phase 2

Conditions

Acute Standardized Cutaneous Wounds (Punch-biopsy Wounds)

Treatments

Drug: GHK-Cu Gel (Copper(II)-peptide complex)

Drug: vehicle Gel (placebo comparator)

Study type

Interventional

Funder types

Industry

Identifiers

NCT07437586

GCU-WH-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.