Acute Standardized Cutaneous Wounds (Punch-biopsy Wounds)
Conditions
Keywords
GHK-Cu, copper peptide, Copper(II)-peptide complex, copper tripeptide-1, wound healing, re-epithelialization, skin repair, scar quality
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.
Detailed 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.
Interventions
DRUGGHK-Cu Gel (Copper(II)-peptide complex)
topical gel, 0.1% w/w; apply a thin film (approx. 0.5 g) once daily for 14 days.
DRUGvehicle Gel (placebo comparator)
ehicle Gel (placebo comparator
Sponsors
Hudson Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Percent wound area reduction | 1 Day | Assessed by digital planimetry from standardized photographs. |
| Proportion of wounds healed | 21 Days | Binary outcomes derived from re-epithelialization assessment. |
| Incidence of suspected or confirmed wound infection | 21 Days | Assessed clinically; swab/culture if clinically indicated |
| Participant-reported wound pain | 14 Days | 0-10 numeric rating scale recorded daily |
| Local tolerability score | 12 weeks | Erythema, burning/stinging, pruritus scored at each visit. |
| Scar quality (POSAS) | 12 Weeks | Patient and Observer Scar Assessment Scale |
| Safety | 14 days | Treatment-emergent adverse events (local/systemic), serious adverse events, and withdrawals due to adverse events. |
Countries
China
Contacts
CONTACTSeni S Lu, Phd
Outcome results
None listed