Study to Assess Efficacy and Safety of Dupilumab in the Treatment of Keloids (NCT05128383) | Clinical Trial Compass
CompletedPhase 2
Study to Assess Efficacy and Safety of Dupilumab in the Treatment of Keloids
United States20 participantsStarted 2023-01-13
Plain-language summary
The study investigates the efficacy and safety of dupilumab in the treatment of keloids
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,…
What they're measuring
1
Patient and Observer Scar Assessment Scale (POSAS)