NCT06226610 Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
| NCT ID | NCT06226610 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Akron Children's Hospital |
| Condition | Pruritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2024-11-21 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 46 participants in total. It began in 2024-11-21 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to test the efficacy of Dupixent in improving post-burn itching symptoms versus the current standard of care.
Eligibility Criteria
Inclusion Criteria: • Persons 18-60 year old with post-burn hypertrophic scars of any size which required grafting or epidermal autografting for an acute burn injury, with continued complaint of pruritus due to inadequate relief from standard of care (medical management by antihistamine and neuroleptic medications) after at least four weeks and are a minimum of four weeks after their last grafting surgery, and who speak English sufficient to participate in the study. Exclusion Criteria: * Currently taking Dupixent for any other diagnosis * known allergy to Dupixent * pregnant and or lactating mothers * anyone treated for pruritus using laser therapy * currently receiving adequate relief for pruritis under standard of care medical management by antihistamine or neuroleptic medications * Currently taking steroids * persons with developmental delays or otherwise unable to complete measures * prisoners or anyone otherwise unable to give their own consent or who is not their own guardian * 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. * 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 * 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. * We similarly exclude anyone treated for pruritis by laser therapy as their perceived benefit could confound our results.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06226610 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Pruritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06226610 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06226610 currently recruiting?
Yes, NCT06226610 is actively recruiting participants. Contact the research team at akhandelwal@akronchildrens.org for enrollment information.
Where is the NCT06226610 trial being conducted?
This trial is being conducted at Akron, United States.
Who is sponsoring the NCT06226610 clinical trial?
NCT06226610 is sponsored by Akron Children's Hospital. The trial plans to enroll 46 participants.