RECRUITING

Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic

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Conditions

PruritisItching, itch

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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 goal of this study is to test the efficacy of Dupixent in improving post-burn itching symptoms versus the current standard of care.

Official Title

A Phase 2 Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy of Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic

Quick Facts

Study Start:2024-11-21
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06226610

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 to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Currently taking Dupixent for any other diagnosis
  2. * known allergy to Dupixent
  3. * pregnant and or lactating mothers
  4. * anyone treated for pruritus using laser therapy
  5. * currently receiving adequate relief for pruritis under standard of care medical management by antihistamine or neuroleptic medications
  6. * Currently taking steroids
  7. * persons with developmental delays or otherwise unable to complete measures
  8. * prisoners or anyone otherwise unable to give their own consent or who is not their own guardian
  9. * one or more of the following existing disorders: conjunctivitis; any co-existing dermatological condition except burns; any type of cancer; requiring dialysis; chronic Stage 3 or higher kidney disease; biliary disorder; gall bladder disorder; or another renal or hepatic disorder which, in the opinion of study physician, deems this study inappropriate for an eligible individual.
  10. * Persons unable to provide their own consent, including prisoners when their incarcerated status is not itself the focus of study, are routinely excluded from clinical trials at this site
  11. * We further exclude persons with other dermatological conditions (other than burn) , which may have pruritis or pain associated with them and who may be treated with medications other than Dupixent, and whose perceived benefit could confound our results.
  12. * We similarly exclude anyone treated for pruritis by laser therapy as their perceived benefit could confound our results.

Contacts and Locations

Study Contact

ANJAY KHANDELWAL, MD
CONTACT
330-543-4649
akhandelwal@akronchildrens.org
Jo Ann Katz, BSN
CONTACT
330-805-6137
jkatz@akronchildrens.org

Study Locations (Sites)

Akron Children's Hospital
Akron, Ohio, 44308
United States

Collaborators and Investigators

Sponsor: Akron Children's Hospital

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 Date2024-11-21
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-11-21
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Itching, itch

Additional Relevant MeSH Terms

  • Pruritis