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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
University of Alberta Hospital
Edmonton, Alberta, Canada
Occurrence of Adverse Events and Tolerability Assessments
Adverse events, Tolerability assessments
Time frame: 4 months
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
Time frame: 4 months
Scar Quality
Repeat measurement of erythema and pigmentation of scars by mexameter following wound closure to the end of study
Time frame: 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
Time frame: 4 months
Area under the plasma concentration-time curve (AUC)
Serial serum samples to determine AUC (0-6h, 0-8h)
Time frame: 4 weeks
Time to reach maximum observed plasma concentration (Tmax)
Serial serum samples to determine Tmax
Time frame: 4 weeks
Maximum observed plasma concentration (Cmax)
Serial serum samples to determine Cmax
Time frame: 4 weeks
Gene expression analysis
RT-qPCR on scar biopsy samples
Time frame: Done on the day of the last dose of treatment (20 days following wounding)
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Histological analysis
Immunohistochemistry on scar biopsy samples
Time frame: Done on the day of the last dose of treatment (20 days following wounding)
Collagen orientation analysis
Collagen orientation index on scar biopsy samples
Time frame: 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
Time frame: 4 months