Punch Biopsy Collection and Analysis Sample Clauses

Punch Biopsy Collection and Analysis. ‌ At baseline/day 0 and day 84, subjects will participate in a 3-mm punch biopsy procedure (post- photography and pre-treatment). Each subject will have 1 biopsy at one side of the NLF (based on the pre-determined randomization) at baseline and 1 biopsy at the other side of the NLF at day 84; total of 2 biopsies per subject at both timepoints. Biopsies will be obtained using standard sterile technique after an intradermal local anesthesia and treated with topical antibiotic and sterile dressing in routine fashion (see Appendix I: Biopsy Procedure and Post-Care). The biopsy specimens will be immediately transferred into RNAlater solution and stored at room temperature for 4 hours and then moved to 4°C. Collected biopsy samples will be sent to the following address for gene expression analysis on icepack (4°C). The biopsy sample will contain the subject number/identification (baseline and day 84), product information, and any other relevant information needed to identify the samples post-analysis. Attn: Xxxxxxx Xxxx, PhD Genemarkers, LLC 000 X Xxxxx Xxxxxx Kalamazoo, Michigan 49007 Phone: (000) 000-0000 Gene expression analysis will be performed via qPCR processing using a panel of biomarkers related to scar tissue formation, collagen, elastin, extracellular matrix integrity, epidermal barrier, anti-aging, antioxidant, cell renewal/regeneration, inflammation, growth factor, and hydration among others.‌
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