Medical Adhesive Repeat Application Study

NCT04869696 | Completed

• 1 other identifier: EM-05-014952
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Skin stripping; TEWL

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Subjects with tape samples

each subject had 8 types of tape samples applied on their arms

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Male and female ages 18-65 years.
• Has sufficient area to fit five (5)1 inch by 2.5-inch sites on each volar forearm.
• Agrees to have five (5) 1 inch by 2.5-inch test sites marked on each volar forearm with a non-toxic permanent marker (Sharpie).
• Agrees to stop the use of all topical products (lotions, creams, oils, sunscreen, bug spray, etc.) on their volar forearms 3 days prior to the start of the study.
• Agrees to not shower within 24 hours of their D1 visit.
• Agrees to not wash volar forearms when washing hands within 24 hours of their D1 visit.
• Agrees to refrain from exercising or drinking hot beverages or cold/iced coffee or tea (caffeinated or energy drinks) during the 2 hours prior to their D1 visit.
• Agrees that if the study personnel feel that they have excessive hair on their volar forearm test sites that the hair may be clipped at the D1 visit.
• Agrees to wear or be willing to change into a short-sleeved shirt or a shirt with sleeves that can be pulled or rolled above the elbows to each visit.
• Able to read, understand, and sign the Informed Consent Form (ICF).
• Willing and able to follow all study requirements and restrictions

You may not qualify if:

• 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.

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Study Sites (1)

Dermico

Broomall, Pennsylvania, 19008, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tape removed from the skin of subjects

Study Officials

• Gary Grove

  Dermico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: May 3, 2021
• Study Start: March 8, 2021
• Primary Completion: May 24, 2021
• Study Completion: May 24, 2021
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

US (1)