Dermico
Broomall, Pennsylvania, 19008, United States
NCT Number: NCT04869696
This study is to determine the relative effects imparted by different medical tapes to skin when comparing normal skin to skin after ten repeated tape applications and removals.
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Notify Me18 year–65 year
All sexes
Observational
Broomall, Pennsylvania, 19008, United States
This study is to evaluate changes to skin after repeated tape stripping on volar forearm with various medical tapes. Assessments of effects to skin include corneocytes, total protein (BCA), Trans-Epidermal Water Loss (TEWL), and cytokine analysis.
The Study will involve the application of eight (8) test articles. In each case, the test articles will be applied to eight (8) sites on the healthy Subject's left and right volar forearms (four [4] sites on the left, and four [4] sites on the right) in a randomized fashion.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Immediately after 10 times of repeated tape application and removal
Measure change in Transepidermal Water Loss (TEWL) from baseline to Tape 10 after repeated tape applications and removals. Baseline TEWL will be measured on another non-taped site.
Time frame: After the removal of Tape 1 and after the removal of Tape 10
Analysis of total protein (BCA) in the skin cells removed by tape samples after repeated tape application and removal. The 1st tape and the 10th tape will be collected for analysis.
Time frame: After the removal of Tape 1 and after the removal of Tape 10
Analysis of percentage area coverage of corneocytes on the tape samples removed from skin. The 1st tape and the 10th tape will be collected for analysis.
Time frame: Immediately after TEWL measurement is completed on each test site
Analysis of cytokine in skin cells removed by tape samples after repeated tape application and removal. Cytokine tape collection will take place after the TEWL measurement is completed on each test site. Control cytokine tape will be collected from another non-taped site.
Solventum US LLC
Industry
Science of Skin: Medical Adhesive Repeat Application Study #2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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