The goal of this clinical trial is to investigate GHK and GHK-Cu blood levels pre- and post-intervention in healthy adults, and to investigate the efficacy of X39 patch on GHK and GHK-Cu blood levels in healthy adults compared to a placebo. The main questions it aims to answer are: * What is the change in GHK and GHK-Cu levels from baseline to Day 8? * What is the difference in the change in GHK and GHK-Cu levels from baseline to Day 8 between the X39 patch and placebo? Researchers will compare X39 patches to placebo patches to evaluate their effects on circulating blood levels of GHK and GHK-Cu in healthy adults. Participants will be asked to complete a questionnaire and use the X39 patch or placebo patch.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Beginning on Day 1, participants will apply the patch daily until Day 7 or the day prior to their last study visit (Visit 3). Participants will apply the patch to the back of the neck (acupuncture point GV14) or directly below the belly button (acupuncture point CV6) on clean, dry skin first thing each morning and remove after approximately 12 hours later or before bed.
Beginning on Day 1, participants will apply the patch daily until Day 7 or the day prior to their last study visit (Visit 3). Participants will apply the patch to the back of the neck (acupuncture point GV14) or directly below the belly button (acupuncture point CV6) on clean, dry skin first thing each morning and remove after approximately 12 hours later or before bed.
KGK Science Inc.
London, Ontario, Canada
Change in GHK levels from baseline to Day 8
Part 1. Change in GHK levels from baseline to Day 8
Time frame: Baseline (Day 0) to Day 8
Change in GHK levels from baseline to Day 8 between the X39 patch and placebo
Part 2. Change in GHK levels from baseline to Day 8 between the X39 patch and placebo
Time frame: Baseline (Day 0) to Day 8
Change in GHK-Cu levels from baseline to Day 8
Part 1. Change in GHK-Cu levels from baseline to Day 8
Time frame: Baseline (Day 0) to Day 8
Change in GHK-Cu levels from baseline to Day 8 between the X39 patch and placebo
Part 2. Change in GHK-Cu levels from baseline to Day 8 between the X39 patch and placebo
Time frame: Baseline (Day 0) to Day 8
Change in GHK levels from baseline to Day 2
Part 1. Change in GHK levels from baseline to Day 2
Time frame: Baseline (Day 0) to Day 2
Quality of Life, RAND SF-36
Part 1. Change in quality of life from baseline to Days 2 and 8, as assessed by the RAND 36-item Short-Form Health Survey (RAND SF-36)
Time frame: Baseline (Day 0) to Day 8
Change in GHK levels from baseline to Day 2 between the X39 patch and placebo
Part 2. Change in GHK levels from baseline to Day 2 between the X39 patch and placebo
Time frame: Baseline (day 0) to Day 2
Change in Quality of Life from Baseline to Days 2 and 8 (RAND 36-Item Short Form Health Survey - RAND SF-36) Between X39 Patch and Placebo
Part 2. Change in quality of life from baseline to Days 2 and 8, as assessed by the RAND 36-Item Short Form Health Survey (RAND SF-36), between the X39 patch and placebo. This questionnaire measures nine scales including physical functioning, role limitations due to physical health, role limitations due to emotional health, pain, general health, energy/fatigue, social functioning, emotional well-being, and health transition. The scores range from 0 to 100 where higher scores indicate a better state of health.
Time frame: Baseline (day 0) to Day 8
Change in GHK-Cu levels from baseline to Day 2
Part 1. Change in GHK-Cu levels from baseline to Day 2
Time frame: Baseline (Day 0) to Day 2
Change in GHK-Cu levels from baseline to Day 2 between the X39 patch and placebo
Part 2. Change in GHK-Cu levels from baseline to Day 2 between the X39 patch and placebo
Time frame: Baseline (day 0) to Day 2
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