Is NCT06373458 recruiting in New York, NY?

Yes, NCT06373458 is currently recruiting participants at its New York, NY location. This keloid clinical trial is actively enrolling qualified participants.

How do I join the keloid clinical trial in New York?

To join this clinical trial in New York, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this New York clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Keloid Clinical Trial in New York, NY

About This Keloid Study in New York

Keloids are common, benign cutaneous overgrowths that manifest clinically as raised, hypertrophic, often hyperpigmented lesions which are formed in response to dermal injury or idiopathic stimuli. Although keloids are a common disease, it's exact incidence and prevalence is not known. Despite the debilitating nature of keloids, current treatment modalities are limited in efficacy; there is no universally effective therapy available to patients. The research team hypothesize that ritlecitinib as a JAK3/TEC inhibitor will be able to reverse both the systemic and local keloid disease process by re-establishing immune homeostasis.

Sponsor: Icahn School of Medicine at Mount Sinai

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT06373458) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Keloid Treatment Options in New York, NY

If you're searching for keloid treatment options in New York, NY, this clinical trial (NCT06373458) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this clinical trial. You'll receive care from experienced keloid specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all keloid clinical trials near you to find additional studies recruiting in your area.

Keloid Clinical Trial in New York, NY

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