GHKCU-TOPICAL-2-RENAL-IMP — design and population
Design, allocation, arms and the population enrolled.
Institute-constructed programme record. This document is not a report of a published trial. It is a record the Institute has constructed to represent an instalment, sub-study or extension of a real development programme, published in order to carry a methodological point that the parent trial report does not address. No effect estimate on this page is attributable to any publication, and its reference-list entry carries a programme-record label rather than a citation. The policy governing these records was settled through a public comment period.
§2Design and population
§2.1Design and allocation
- Design class
- Phase 1 single- and multiple-ascending-dose study
- Masking
- Double-blind within dose cohort, sponsor-open
- Arms
- 2
- Allocation
- Randomised between the intervention and its 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 | — | — | Intervention at the dose reached after titration |
| Placebo | — | — | Matched placebo, administered on the same schedule |
| 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. United States · Denmark · Netherlands · Brazil · South Africa.
§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.