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JAK3/TEC Inhibitor

Participants with no keloidectomy for Keloid

Phase 2

Recruiting

Led By Emma Guttman, MD, PhD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to take oral medication without crushing, dissolving or chewing tablets

Patients who receive keloidectomy at Day 1/ Baseline only: 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 9 months (visit 9)

Awards & highlights

Study Summary

"This trial aims to investigate a new treatment for keloids, which are raised, often dark-colored skin growths that occur after skin injuries. Current treatments for keloids are not very effective. The researchers

Who is the study for?

This trial is for individuals with keloids, which are raised, often discolored skin growths that develop at the site of an injury. Participants can either currently have keloids or be undergoing surgery to remove them (keloidectomy). The study aims to include those who need new treatment options.Check my eligibility

What is being tested?

The trial is testing Ritlecitinib, a medication thought to potentially treat keloids by targeting certain pathways in the immune system. Researchers believe it might help restore balance and reduce the overgrowth of scar tissue.See study design

What are the potential side effects?

Potential side effects of Ritlecitinib may include but are not limited to changes in blood counts, liver enzyme alterations, increased cholesterol levels, and possible risk of infections due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can swallow pills without needing to break them down.

Select...

I have a keloid larger than 2 cm on my earlobe or 3 cm elsewhere, not improved by treatments like creams or injections.

Select...

I have reported moderate to severe pain, itch, or impact on my life quality.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 9 months (visit 9)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 9 months (visit 9)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 9 months (visit 9) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Detroid Keloid Scale Score

Recurrence Rate

Secondary outcome measures

Change in DLQI (Dermatology Life Quality Index)

Change in Detroid Keloid Scale Score (DKS)

Change in Itch-NRS

+3 more

Side effects data

From 2022 Phase 1 trial • 12 Patients • NCT05097716

COVID-19

100%

80%

60%

40%

20%

Study treatment Arm

Period 1: Tolbutamide

Period 2: Ritlecitinib

Period 2: Ritlecitinib + Tolbutamide

Trial Design

2Treatment groups

Experimental Treatment

Group I: Participants with no keloidectomyExperimental Treatment1 Intervention

A total of 10 patients with no keloidectomy during the study and with at least one keloid measuring ≥3 cm or multiple keloids, measuring ≥1 cm in length each, as Group 2

Group II: Participants receiving keloidectomyExperimental Treatment1 Intervention

A total of 20 patients receiving keloidectomy (~50% earlobe keloidectomy cap) at Day 1 as Group 1

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ritlecitinib

2020

Completed Phase 1

~50

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

862 Previous Clinical Trials

525,603 Total Patients Enrolled

1 Trials studying Keloid

44 Patients Enrolled for Keloid

PfizerIndustry Sponsor

4,570 Previous Clinical Trials

10,916,727 Total Patients Enrolled

Emma Guttman, MD, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

7 Previous Clinical Trials

387 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for patients to participate in this research study?

"As detailed on clinicaltrials.gov, this investigation is actively seeking participants. Its initial posting was on April 15th, 2024, and the most recent update also occurred on that same date."

Answered by AI

What is the current number of participants eligible for enrollment in this clinical research study?

"Indeed, as per clinicaltrials.gov, this particular research study is actively seeking volunteers. The trial was initially listed on April 15th, 2024 and the most recent update was also on April 15th of the same year. They aim to enroll a total of 30 participants at one location."

Answered by AI

What is the level of safety for individuals without keloidectomy undergoing this procedure?

"Our team at Power has assessed the safety of participants without keloidectomy to be a 2 on our scale. This rating corresponds to a Phase 2 trial, indicating some existing safety data but lacking evidence in efficacy."

Answered by AI

What is the primary objective of this research endeavor?

"The primary objective of this study, to be evaluated at approximately 9 months (Visit 9), is the alteration in Detroid Keloid Scale Score. Secondary outcomes consist of shifts in Peak keloid tension, as defined by the effectiveness of ritlecitinib gauged through peak keloid tension assessments using a tonometer measuring skin "firmness" on a scale from 0-100 with higher scores indicating increased "rigidity". Additionally, adjustments in Detroid Keloid Scale Score characterized by Ritlecitnib efficacy assessed via the Detroid Keloid Scale will be examined. This scale comprises an observer assessment and patient questionnaire"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy

Emma Guttman 2024. "Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06373458.

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