Testing Dupixent for Itching After Burns
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
This study is testing if Dupixent can help adults with itching after burns feel better compared to regular treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Akron Children's Hospital Academic / other |
| Locations | 1 site (Akron, Ohio) |
| Trial ID | NCT06226610 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of Dupixent in alleviating itching symptoms in adults with post-burn pruritus compared to standard care. Participants will receive either Dupixent or a placebo through a series of injections over 13 weeks. They will also complete questionnaires to assess itch severity, quality of life, and treatment benefits. The study focuses on individuals who have not found relief from existing treatments for their itching.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with persistent itching due to post-burn hypertrophic scars who have not responded adequately to standard treatments.
Not a fit: Patients currently receiving adequate relief from itching through standard medical management or those with certain exclusions, such as known allergies to Dupixent, will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce itching and improve the quality of life for patients suffering from post-burn pruritus.
How similar studies have performed: While this approach is relatively novel for post-burn pruritus, similar studies using Dupixent for other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Akron, Ohio
- Akron Children's Hospital — Akron, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Anjay Khandelwal, Md
- Email: akhandelwal@akronchildrens.org
- Phone: 330-543-4649
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.