Overview
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.
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.
Eligibility
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.
