Can a daily pill stop keloids from coming back?
NCT ID NCT06373458
First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times
Summary
This study tests whether the drug ritlecitinib can prevent keloids from returning after surgical removal. Keloids are raised, often itchy scars that grow beyond the original wound. The trial will enroll 30 adults who will take a daily pill for 36 weeks. Researchers will measure keloid recurrence and severity using a special scale and a skin hardness device.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ritlecitinib (a JAK inhibitor drug taken as a daily pill)
- What this could lead to
- If successful, this could point toward a new treatment option that reduces keloid recurrence and severity after surgery.
- What could go wrong
- This is a small, early-phase (2a) trial with only 30 participants, so results may not apply to everyone. The drug may not work better than existing treatments, and side effects are still being studied.
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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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- 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 years and older
- 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female patients ≥ 18 years of age at the time of signing the informed consent document (not more than 10% of the patients can be \> 50 years of age). * Patient is able to understand and voluntarily sign an informed consent document prior to participation in any study assessments or procedures. * Patient is able to adhere to the study visit schedule and other protocol requirements. * Patients who receive keloidectomy at Day 1/ Baseline only (Group 1): Patient has minimum of one keloid measuring ≥2 cm in length on earlobe or ≥3.0 cm in length on areas) other than earlobe, which has failed prior minimally invasive treatments for keloids including topicals and intralesional corticosteroid injections and that can be surgically resected at Day 1/ Baseline. * Patients who do not receive keloidectomy at Day 1/ Baseline only (Group 2): * Patient has a minimum of either one keloid measuring ≥3 cm in length, or multiple keloids, each measuring ≥1 cm in length , which failed prior minimally invasive treatments for keloids including topicals and intralesional corticosteroid injections. However, at least one keloid should not have been treated with surgery, cryotherapy, radiation, or any other procedure that leads to a deformity that interferes with proper clinical assessments. * Patient reports either Pain-NRS ≥4 , Itch-NRS ≥4, or DLQI ≥8both at Visit 1 (Screening) and Visit 2 (Baseline) * Patient is judged to be in otherwise good overall health as judged by the investigator, based on medical history, physical examination, and laboratory testing. (NOTE: The definition of good health means a patient does not have uncontrolled significant co-morbid conditions). * Ability to take oral medication without crushing, dissolving or chewing tablets. * Females of childbearing potential (FOCBP) must have a negative pregnancy test at Screening and Day 1/ Baseline. While on ritlecitinib and for at least 28 days after taking the last dose of ritlecitinib, FOCBP who engage in activity in which conception is possible must use the approved contraceptive methods. Exclusion Criteria: * Patient has a persistent or recurring bacterial infection requiring systemic antibiotics, or clinically significant viral or fungal or helminth parasitic infections, within 2 weeks of the Screening Visit. Any treatment of such infections must have been completed at least 2 weeks prior to the Screening Visit and no new/recurrent infections should have occurred prior to the Baseline Visit. * Patient with current or history of positive human immunodeficiency virus (HIV), or congenital or acquired immunodeficiency (i.e., Common Variable Immunodeficiency \[CVID\]), or active or untreated latent tuberculosis. * Infected with hepatitis B or C virus. * Patients who have history of single episode of disseminated herpes zoster (HZ) or disseminated herpes simplex or recurrent (\> 1 episode of) localized dermatomal HZ * Patient has clinically significant (as determined by the investigator) renal, hepatic, hematologic, intestinal, endocrine, pulmonary, cardiovascular, neurological, psychiatric, immunologic, or other major uncontrolled diseases that will affect the health of the patient during the study or interfere with the interpretation of study results. * Patient has a suspected or active lymphoproliferative disorder or malignancy; OR a history of malignancy within 5 years before the Baseline assessment, except for completely treated in situ non-melanoma skin and cervical cancers without evidence of metastasis. * Any gastrointestinal or metabolic condition that could interfere with the absorption of the oral medication. * Active alcohol and/or drug abuse. * History of thrombosis/ thromboembolic event, known coagulopathy. * Additional skin disease that might interfere with keloid clinical assessments. * Have hearing loss with progression over the previous 5 years, or sudden hearing loss, or middle or inner ear disease including otitis media, cholesteatoma, Meniere's disease, labyrinthitis, or other auditory condition that is considered acute, fluctuating, or progressive. * Patient has received a live attenuated vaccine ≤ 30 days prior to study initiation. * History of adverse systemic or allergic reactions to any component of the study drug. * Recent surgery excluding keloidectomy within 4 weeks and keloidectomy within 6 months prior to trial initiation. * Recent cryotherapy within 3 months, laser therapy within 3 months, or radiation or any other procedure within 6 months. * Use of systemic immunosuppressive medications, including, but not limited to, cyclosporine, systemic or intralesional corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, tacrolimus, or ultraviolet (UV) phototherapy with or without Psoralen Ultraviolet A (PUVA) therapy within 4 weeks prior to trial initiation. Compression garments and silicone sheets may be allowed. * Treatment with medication that might interfere with blood levels or have a major impact on the clinical readout of the study drug. This includes the following: * Patient on concomitant medications that are substrates of CYP3A4 or CYP1A2 with narrow therapeutic index where small concentration changes may lead to serious adverse reactions * Patient on concomitant medications that are strong inducers of CYP3A4 as this might cause loss of efficacy of ritlecitinib * Use of an oral JAK inhibitor (tofacitinib, ruxolitinib, ritlecitinib) within 3 months prior to the Baseline visit. * Patient has used topical corticosteroids, and/or tacrolimus, and/or pimecrolimus, and/or topical chemotherapy on any keloid lesions within 2 weeks prior to the Baseline visit. These will be allowed during the study on areas other than keloid lesions (if applicable) but not on any keloid lesions. * Female patient who is pregnant or breast feeding * FOCBP with unwillingness or inability to use a contraception method during the time of participation in the trial (Appendix 1) * Abnormality in hematology, chemistry profiles, and ECG during screening: * Platelet count: \<75000/ mm3 * Lymphocytes: \<600/ mm3 * Absolute neutrophil count: \<1200/ mm3 * Hemoglobin: \<9.0 g/dL * ALT or AST: \>3.0xULN * eGFR: \<30 mL/min * ECG that demonstrates clinically relevant abnormalities that may affect patient safety
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Icahn School of Medicine at Mount Sinai
RECRUITINGNew York, New York, 10029, United States
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