Can an asthma drug tame stubborn keloid scars?
NCT ID NCT05128383
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Keloids are raised, itchy scars that grow beyond the original wound and often return after treatment. Researchers are testing dupilumab, an antibody that blocks two inflammation signals, in 20 adults with keloids. Participants receive the drug and doctors track scar appearance, itch, and hardness over 24 weeks using standard scar scales. The goal is to see whether dupilumab can make keloids smaller, softer, and less bothersome.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dupilumab, an antibody drug that blocks two inflammation signals
- What this could lead to
- If it works, dupilumab could become a non-surgical option for softening and flattening keloid scars, which often return after removal.
- What could go wrong
- This is a small, open-label Phase 2 study with 20 people and no placebo group, so any improvement could reflect chance or the natural course of scarring. Dupilumab can cause injection-site reactions, eye irritation, and cold sores.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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20 people
The number who actually took part.
- Started
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Jan 2023
- Finished
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Jun 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Plasma zaps scars: new device aims to smooth skin
- 7,000 volunteers needed to crack the genetic code of keloids.