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Completed NCT05128383

Study to Assess Efficacy and Safety of Dupilumab in the Treatment of Keloids

Conditions: Keloid

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 20
Sponsor: Beth Israel Deaconess Medical Center

Location: Beth Israel Deaconess Medical Center Boston Massachusetts

Summary

The study investigates the efficacy and safety of dupilumab in the treatment of keloids

Eligibility Criteria

Inclusion Criteria: * Men and women between the ages of 18 and 65 at the time of dupilumab initiation. * Subjects must have either one keloid with ≥ 2 cm length-wise or at least two keloids with ≥ 0.4 cm (width) x 0.4 cm (length) * Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Exclusion Criteria: * History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis (Tb) infection as defined by a positive QuantiFERON TB-Gold test at screening. * Known infection with HIV, hepatitis B or hepatitis C at screening. * Are currently pregnant, breastfeeding, or planning to get pregnant during the study. * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 8 weeks after stopping treatment. Methods of acceptable birth control are listed below under "Women of Childbearing Potential" * Previous hypersensitivity reaction to dupilumab. * Patients with acute asthma, acute bronchospasm or status asthmaticus. * Patients with known helminth infections. * Currently on any other immunosuppressant systemic medication or within 28 days of baseline visit. * Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy. * Are participating in another study using an investigational agent or procedure during participation in this study or within 28 days prior to baseline visit. * Any other treatment for keloids with 28 days prior to baseline visit, including silicone gel/sheets, laser therapy, intralesional steroid or 5-fluorouracil injections, topical steroid, cryotherapy, surgery, or radiation therapy. * Has had a live vaccine

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05128383). StuddyBuddy aggregates publicly available trial information.