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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent wound area reduction | Assessed by digital planimetry from standardized photographs. | 1 Day |
| Proportion of wounds healed | Binary outcomes derived from re-epithelialization assessment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seni S Lu, Phd | Contact | +86 13076790030 | Seni-Lu@beijing-biotech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Shenzhen Hospital | Recruiting | Shenzhen | Guangdong | 518036 | China |
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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.
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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.
| vehicle Gel (placebo comparator) | Drug | ehicle Gel (placebo comparator |
|
| 21 Days |
| Incidence of suspected or confirmed wound infection | Assessed clinically; swab/culture if clinically indicated | 21 Days |
| Participant-reported wound pain | 0-10 numeric rating scale recorded daily | 14 Days |
| Local tolerability score | Erythema, burning/stinging, pruritus scored at each visit. | 12 weeks |
| Scar quality (POSAS) | Patient and Observer Scar Assessment Scale | 12 Weeks |
| Safety | Treatment-emergent adverse events (local/systemic), serious adverse events, and withdrawals due to adverse events. | 14 days |