Trial abstract · §2
GHKCU-TOPICAL-1 — design and population
Design, allocation, arms and the population enrolled.
§2Design and population
§2.1Design and allocation
- Design class
- Randomised, double-blind, placebo-controlled, parallel-group
- Masking
- Double-blind (participant, investigator and sponsor)
- Arms
- 4
- Allocation
- Randomised across dose arms and a common comparator
- Endpoint adjudication
- Not applicable to the primary endpoint of this design
- Data monitoring
- As specified in the protocol
§2.2Arms
Table 2. Randomised arms. Illustrative: arm-level allocations are reconstructed by the Institute from the design class and the randomised total where the published report does not state them.
| Arm | Allocated | Share | Description |
|---|---|---|---|
| GHK-Cu, dose level 1 | — | — | Randomised dose arm |
| GHK-Cu, dose level 2 | — | — | Randomised dose arm |
| GHK-Cu, dose level 3 | — | — | Randomised dose arm |
| Placebo | — | — | Matched placebo |
| The randomised total is not recorded by the Institute and arm-level figures are therefore not presented. | |||
§2.3Population
Indication. Cutaneous wound healing and tissue repair
Restoration of epithelial and dermal integrity following injury, assessed by closure rate, area reduction and scar quality.
Geographic footprint. Italy · Taiwan.
§2.4Eligibility as the Institute reads it
- Included. Restoration of epithelial and dermal integrity following injury, assessed by closure rate, area reduction and scar quality.
- Excluded. Participants for whom the intervention is contraindicated, including wilson disease or any disorder of copper handling would be an absolute contraindication…. Exclusion criteria narrow the population to which the estimate applies and are the principal source of indirectness where a trial estimate is applied to ordinary practice.
Compound Evidence Institute · CEI-TR-0117/2 · https://compoundevidence.com/trials/ghkcu-topical-1/design/ · retrieved 30 July 2026