Study of Skin Cells That Stop Replicating (Senescent) During Wound Healing

NCT02755584 | Completed

• 2 other identifiers: 99991610116-AG-N101
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Cellular senescence is the aging of cells. It is a complex process that may be connected with aging and age-related diseases. It is unknown if these cells appear around wound sites in humans a few days after skin injury and if there are differences in young and old individuals. This study is being done to look at how cells in your body respond to small skin wounds. This information may help treat age-related diseases. Objective: To study how cells in the body respond to small skin wounds. Eligibility: Healthy adults ages 20-39 or 70+ Design: Participants will be screened with medical history, physical exam, and blood sample. They will fast before the screening visit. Women will have a urine pregnancy test. Participants will have 3 study visits over about 3 weeks. Visits 1 and 2: Participants will fast before and have blood taken. Women will have a urine test. All participants will have 2 skin biopsies. A spot on the upper arm will be numbed. Two small pieces of skin will be removed. They will keep the area covered until the next visit. Visit 3: Participants will have their vital signs taken. Their biopsy wounds will be measured and photographed. ...

Conditions

Healthy Volunteers

Keywords

Aging; Senescent Cells; Natural History

Outcome Measures

Primary Outcomes (1)

• To demonstrate that in humans, senescent cells will appear around wound sites after skin injury.

  Understanding the physiological role of senescent cells is critically important for understanding aging and age related diseases. Our preliminary results showed that there may be a difference in rate of granulation tissue formation with ethnicity.

  Basline visit 1and visit 2 six different days

Secondary Outcomes (1)

• The number of senescent cells induced by skin injury increases with age. The wound healing process, as determined by the size of the healed wounds, may be associated with aging.

  ongoing

Study Arms (1)

Healthy Volunteers

between the ages of 20-39 years and 70 years old and older

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population includes healthy volunteers between the ages of 20-39 years and 70 years old and older. Each age group will be men and women Caucasian and African American.

You may qualify if:

• Age 20 - 39 years or age 70 years and older.

You may not qualify if:

• Are able to understand the study risks and procedures, and consent to participate in the study.
• Are able to read and speak English.
• Caucasian or African American
• Previous enrolled participants.
• A medical condition that requires the use of chronic anticoagulant medication use such as warfarin, clopidogrel, heparin or antiplatelet agents other than low dose aspirin (81mg).
• History of increased bleeding due to either a known medical condition or an undiagnosed cause.
• A medical condition that causes impaired wound healing such as diabetes.
• Current androgenic/anabolic and/or corticosteroid use or use within 90 days of the procedure (ocular corticosteroid use okay).
• Current antibiotic or anti-viral use or use within 60 days of the procedure.
• Active infections or chronic skin conditions that would prevent access to the biopsy area.
• Taking non-steroidal anti-inflammatory agents (NSAIDs) such as Motrin (Ibuprofen), Advil (Ibuprofen) or Naprosyn (Naproxen) and the
• participant is unable to stop taking them 3 days before the biopsy and 1 day after the biopsy procedure.
• Taking more than 81 mg of aspirin a day and the participant is unable to stop taking it for 3 days before the biopsy and 1 day after the biopsy procedure.
• Allergic to Lidocaine (Xylocaine) or any other local anesthetic or the participant has had in the past a severe allergic reaction to similar drugs.
• Allergic to topical betadine solution.

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (1)

National Institute on Aging, Clinical Research Unit

Baltimore, Maryland, 21224, United States

Location

Study Officials

• Chee W Chia, M.D.

  National Institute on Aging (NIA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: April 29, 2016
• Study Start: June 30, 2016
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: April 1, 2026

Record last verified: 2026-02-24

Locations

US (1)