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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with tape samples | each subject had 8 types of tape samples applied on their arms |
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| Measure | Description | Time Frame |
|---|---|---|
| Chang in TEWL from skin after repeated tape stripping | 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. | Immediately after 10 times of repeated tape application and removal |
| Changes to skin after repeated tape stripping (total protein) | 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. | After the removal of Tape 1 and after the removal of Tape 10 |
| Changes to skin after repeated tape stripping (corneocytes) | 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. | After the removal of Tape 1 and after the removal of Tape 10 |
| Changes to skin after repeated tape stripping (Cytokine) | 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. | Immediately after TEWL measurement is completed on each test site |
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Inclusion Criteria:
Exclusion Criteria:
If female, is pregnant, nursing, or planning a pregnancy during the study as determined by interview.
If female, is currently experiencing hot flashes (this affects the measurements) or has increased localized or generalized sweating (hyperhidrosis).
Is a smoker.
Has a history of lightening or darkening of the skin due to tape application and removal.
Has diabetes Type 1 or Type 2.
Has a current skin condition on the volar forearms (e.g., psoriasis, eczema, atopic dermatitis, etc., or active cancer) that the Investigator or designee deems inappropriate for participation or could interfere with the outcome of the study.
Is currently taking, or in the past 2 weeks has taken any anti-inflammatory drug (e.g., aspirin, ibuprofen, Celebrex [COX-2 inhibitor], corticosteroids), immunosuppressive drugs, or antihistamine medications.
Is currently applying, or in the past 2 weeks has applied topical drugs to the volar forearm test sites.
Has any medical condition that, in the Investigator's judgment, makes the Subject ineligible or places the Subject at undue risk.
Is currently participating in any clinical testing, including other studies being conducted at Dermico LLC.
Has damaged skin in or around the test sites, which includes sunburn, extremely deep tans, uneven skin tones, tattoos, scars, excessive hair that they are not willing to have clipped, numerous freckles, blemishes, or other disfiguration of the test sites.
Has a confirmed allergy or sensitivity to adhesives.
Has a history of a confirmed or suspected COVID-19 infection within 30 days prior to the study visit.
Has had contact with a COVID-19-infected person or persons within 14 days prior to the study visit.
Individual or a member of the individual's household has traveled internationally within 14 days prior to the study visit.
Has experienced any of the following self-reported symptoms of COVID-19 within 2 weeks prior to the study visit:
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Subjects will consist of men and women aged 18 to 65 years old, Fitzpatrick Skin Type I-VI. Candidates will be recruited from a pool of healthy men and women who meet the inclusion/exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Gary Grove | Dermico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermico | Broomall | Pennsylvania | 19008 | United States |
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Tape removed from the skin of subjects