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The purpose of this study is to assess the safety and local tolerability of two different concentrations of of SCX-001 cream, as compared to placebo, when topically applied twice a day for 21 days to artificially induced dermal wounds in healthy volunteers. In addition, the absorption and elimination of profiles of this topically applied product will be determined through pharmacokinetic sampling. Assessments for effect of SCX-001 vs. placebo will be done but are considered exploratory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.0 % SCX-001 cream | Experimental | Subjects randomized to this arm will have one lateral hip wound treated with 1.0% SCX-001 cream and one wound treated with placebo. Intra-subject hip wound treatment is randomly allocated |
|
| 3.0% SCX-001 cream | Experimental | Subjects randomized to this arm will have one lateral hip wound treated with 3.0% SCX-001 cream and one wound treated with placebo. Intra-subject hip wound treatment is randomly allocated |
|
| Placebo cream | Placebo Comparator | Subjects randomized to this arm will have both lateral hip wounds treated with Placebo cream. Intra-subject hip wound treatment is randomly allocated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCX-001 | Drug | Nefopam cream formulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Adverse Events and Tolerability Assessments | Adverse events, Tolerability assessments | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Scar Size | Repeat measurement of scar size by ultrasound following wound closure to the end of study and digital camera following wounding to the end of the study | 4 months |
| Scar Quality | Repeat measurement of erythema and pigmentation of scars by mexameter following wound closure to the end of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo |
| Other |
Cream formulation without Nefopam |
|
| 4 months |
| Time to Wound Closure | Repeat examination of wounds for closure defined as 100% epithelialization of the wound with no exudate observed assessed form time of wounding to wound closure on both hips | 4 months |
| Area under the plasma concentration-time curve (AUC) | Serial serum samples to determine AUC (0-6h, 0-8h) | 4 weeks |
| Time to reach maximum observed plasma concentration (Tmax) | Serial serum samples to determine Tmax | 4 weeks |
| Maximum observed plasma concentration (Cmax) | Serial serum samples to determine Cmax | 4 weeks |
| Gene expression analysis | RT-qPCR on scar biopsy samples | Done on the day of the last dose of treatment (20 days following wounding) |
| Histological analysis | Immunohistochemistry on scar biopsy samples | Done on the day of the last dose of treatment (20 days following wounding) |
| Collagen orientation analysis | Collagen orientation index on scar biopsy samples | Done on the day of the last dose of treatment (20 days following wounding) |
| Overall Satisfaction | Repeat measurement of both subject and investigator satisfaction with scar appearance by Subject and Observer Scar Assessment Scale (POSAS) following wound closure to the end of study | 4 months |