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Nexagonâ„¢ is a novel compound that promotes wound healing by temporarily disrupting cellular communication at the wound site, thereby promoting accelerated healing, reducing inflammation and pain. This randomized double-blind study will assess the safety, tolerability and clinical effect of Nexagonâ„¢ when applied to skin wounds created by punch biopsy in healthy volunteers. 43 healthy, fair-skinned males and females between ages 18-40 will be enrolled. Subjects will be reviewed again at 3 months and 9 months for follow-up safety assessments and wound appearance evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nexagonâ„¢ or Nexagonâ„¢ vehicle | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessed by the incidence of adverse events from the time of application of the investigational product | Until the end of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to complete closure of the wounds | 35 days post-application | |
| Rate of healing | 35 days post application | |
| Clinical assessment by rating scales |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rod Ellis-Pegler | Auckland Clinical Studies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auckland Clinical Studies | Auckland | New Zealand |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| 35 days post application |
| Pain | 35 days post application |