Acute Standardized Cutaneous Wounds (Punch-biopsy Wounds)Phase 2CuHealNCT07437586
Topical GHK-Cu Gel for Acute Skin Wound Healing
A Phase 2 study testing GHK-Cu Gel (Copper(II)-peptide complex) in people with Acute Standardized Cutaneous Wounds (Punch-biopsy Wounds), run by Hudson Biotech at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Standardized Cutaneous Wounds (Punch-biopsy Wounds)
- What is being tested?
- GHK-Cu Gel (Copper(II)-peptide complex)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2026to 17 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Zhen J Peng, Phd, +86 13076790039, Zhen-Peng@beijing-biotech.com
About this study
Official title: A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Split-Wound Study of Topical GHK-Cu (Copper(II)-Peptide Complex) Gel to Accelerate Re-Epithelialization of Standardized Acute Skin Wounds in Healthy Adults
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.
Read the 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.
- Being tested
- GHK-Cu Gel (Copper(II)-peptide complex), vehicle Gel (placebo comparator)
- Keywords
- GHK-Cu, copper peptide, Copper(II)-peptide complex, copper tripeptide-1, wound healing, re-epithelialization, skin repair, scar quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Arm A: GHK-Cu Gel (0.1% w/w) applied once daily to the assigned wound for 14 days + standard non-adh | Experimental | Not described Receives: Drug: GHK-Cu Gel (Copper(II)-peptide complex); Drug: vehicle Gel (placebo comparator) |
| Arm B: Vehicle Gel applied once daily to the assigned wound for 14 days + standard non-adherent dres | Experimental | Not described Receives: Drug: GHK-Cu Gel (Copper(II)-peptide complex); Drug: vehicle Gel (placebo comparator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete re-epithelialization (days) of each wound, defined as 100% epithelial coverage without drainage, confirmed by blinded clinical assessment and standardized photography.
Measured: 21 Days
Secondary outcomes (7)
Percent wound area reduction
Assessed by digital planimetry from standardized photographs.
Measured: 1 Day
Proportion of wounds healed
Binary outcomes derived from re-epithelialization assessment.
Measured: 21 Days
Incidence of suspected or confirmed wound infection
Assessed clinically; swab/culture if clinically indicated
Measured: 21 Days
Participant-reported wound pain
0-10 numeric rating scale recorded daily
Measured: 14 Days
Local tolerability score
Erythema, burning/stinging, pruritus scored at each visit.
Measured: 12 weeks
Scar quality (POSAS)
Patient and Observer Scar Assessment Scale
Measured: 12 Weeks
Safety
Treatment-emergent adverse events (local/systemic), serious adverse events, and withdrawals due to adverse events.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start2 Feb 2026
- Primary completion14 Feb 2027 (estimated)
- Study completion17 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Standardized Cutaneous Wounds (Punch-biopsy Wounds)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hudson Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437586
- Sponsor's protocol ID
- GCU-WH-001
- Acronym
- CuHeal
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Split-Wound Study of Topical GHK-Cu (Copper(II)-Peptide Complex) Gel to Accelerate Re-Epithelialization of Standardized Acute Skin Wounds in Healthy Adults
- ClinicalTrials.gov ID
- NCT07437586
- Acronym / sponsor ID
- CuHeal / GCU-WH-001
- Keywords
- GHK-Cu, copper peptide, Copper(II)-peptide complex, copper tripeptide-1, wound healing, re-epithelialization, skin repair, scar quality
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hudson BiotechIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 14 Feb 2027 (estimated)
- Study completion
- 17 Mar 2028 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm A: GHK-Cu Gel (0.1% w/w) applied once daily to the assigned wound for 14 days + standard non-adh | Experimental | Drug: GHK-Cu Gel (Copper(II)-peptide complex), Drug: vehicle Gel (placebo comparator) |
| Arm B: Vehicle Gel applied once daily to the assigned wound for 14 days + standard non-adherent dres | Experimental | Drug: GHK-Cu Gel (Copper(II)-peptide complex), Drug: vehicle Gel (placebo comparator) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GHK-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. | Drug | Arm A: GHK-Cu Gel (0.1% w/w) applied once daily to the assigned wound for 14 days + standard non-adh, Arm B: Vehicle Gel applied once daily to the assigned wound for 14 days + standard non-adherent dres |
| vehicle Gel (placebo comparator)ehicle Gel (placebo comparator | Drug | Arm A: GHK-Cu Gel (0.1% w/w) applied once daily to the assigned wound for 14 days + standard non-adh, Arm B: Vehicle Gel applied once daily to the assigned wound for 14 days + standard non-adherent dres |
Primary outcome
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
7 secondary outcomes
Percent wound area reduction
Time frame: 1 Day
Proportion of wounds healed
Time frame: 21 Days
Incidence of suspected or confirmed wound infection
Time frame: 21 Days
Participant-reported wound pain
Time frame: 14 Days
Local tolerability score
Time frame: 12 weeks
Scar quality (POSAS)
Time frame: 12 Weeks
Safety
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GHK-Cu Gel (Copper(II)-peptide complex) in people with Acute Standardized Cutaneous Wounds (Punch-biopsy Wounds), run by Hudson Biotech at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seni S Lu, Phd (+86 13076790030, Seni-Lu@beijing-biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.