RECRUITING

Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to answer: how do inflammation and anti-inflammatory skin therapies work in the skin? Inflammation is a protective response from the body's immune system to injury, disease, or irritation. It is a process by which your body's white blood cells and the things they make protect you from infection from outside invaders such as bacteria and viruses.

Official Title

Biologics and Blistering - Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation Through Suction Blistering

Quick Facts

Study Start:2022-11-15
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05535738

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy adult subjects over the age of 18 years with no skin diseases
  2. * Patients with dermatologic conditions such as atopic dermatitis, history of localized non-melanoma, keratinocytic skin cancer
  3. * Patients with previous clinical patch testing
  4. * UMass Medical School students and employees are eligible to participate.
  5. * Non-English-speaking individuals are also eligible with the assistance of an interpreter and an approved short form consent in the appropriate language.
  1. * Adults unable to give consent
  2. * History of the following specific dermatologic conditions (which would be confounders due to their particular immunologic etiologies, specifically the TNFa and IL-17 pathways which oppose the Th2 pathway): pityriasis rubra pilaris and psoriasis
  3. * Patients actively receiving whole body phototherapy
  4. * Patients actively receiving systemic broad-spectrum immunosuppression (prednisone, mycophenolate mofetil, azathioprine, methotrexate)
  5. * Any history of poor wound healing
  6. * History of uncontrolled diabetes
  7. * History of easily torn skin
  8. * Any known cardiac arrhythmia or history of heart failure
  9. * History of demyelinating disease
  10. * History of liver disease or alcohol abuse
  11. * History of melanoma
  12. * Pregnant women
  13. * Individuals who are high risk for tuberculosis including prisoners, immigrants from TB- endemic areas, or US-based travelers who have visited TB-endemic areas
  14. * Individuals with a self-reported personal history of infection with latent or active tuberculosis, HIV, Hepatitis B, or Hepatitis C will not be included, because the type of immunotherapies that will be used in this study may interfere with these conditions.
  15. * For similar reasons, we will not be including individuals with signs of current or active infection, self-reported personal history of recurrent infections, or conditions that compromise the immune system, such as patients with malignancy (except non- melanoma, keratinocytic skin cancers).

Contacts and Locations

Study Contact

Celia Hartigan, RN
CONTACT
774-455-4758
celia.hartigan@umassmed.edu

Principal Investigator

John Harris, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Massachusetts Chan Medical School

Study Locations (Sites)

University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01605
United States

Collaborators and Investigators

Sponsor: John Harris

  • John Harris, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Massachusetts Chan Medical School

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-15
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2022-11-15
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • skin inflammation
  • allergic contact dermatitis

Additional Relevant MeSH Terms

  • Skin Inflammation
  • Allergic Contact Dermatitis