Trial · NCT06373458
Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy
NCT06373458, Phase 2, Recruiting, Icahn School of Medicine at Mount Sinai
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy. Trials, record NCT06373458. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06373458
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy
- NCT number
- NCT06373458
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 30 participants, estimated
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Keloid
- Interventions
- Ritlecitinib
- First posted
- 2024-04-18
- Last updated
- 2026-09-01
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recurrence Rate | at 9 months (Visit 9) | Recurrence Rate at 9 months (Visit 9) in subjects that received keloidectomy |
| Primary | Change in Detroid Keloid Scale Score | Baseline and 9 months (Visit 9) | Change from Baseline in the Detroit Keloid Scale at 9 months (visit 9) (excluding those without measurable keloids after keloidectomy). Detroit Keloid Scale is a questionnaire consisting of 3 questions that assess the clinical observation (observer keloid assessment) and 4 questions that evaluate the 3 clinical signs of keloids and the impact of keloids on the patient's well-being (patient keloid questionnaire). Keloid Severity (Calculated from Total) 0-4 = mild; 5-9 = moderate; 10-14 = severe Total scores from 0-14, with higher scores indicate greater symptom severity. |
| Secondary | Change in Peak keloid tension | Visits 2 (Week 0) and up to visit 11 (Week 60) | Efficacy of ritlecitinib measured by peak keloid tension. Peak keloid tension measures the "hardness" of the skin using an instrument called a tonometer. Full scale ranges 0-100, with higher scores indicating greater "hardness". |
| Secondary | Change in Detroid Keloid Scale Score (DKS) | Visits 2 (Week 0) and up to visit 11 (Week 60) | Efficacy of Ritlecitnib measured using Detroid Keloid Scale. The DKS is a questionnaire consisting of 3 questions that assess the clinical observation (observer keloid assessment) and 4 questions that evaluate the 3 clinical signs of keloids and the impact of keloids on the patient's well-being (patient keloid questionnaire). Keloid Severity (Calculated from Total) 0-4 = mild 5-9 = moderate 10-14 = severe Total scale from 0-14. Higher scores indicate greater symptom severity. |
| Secondary | Change in Pain Numerical Rating Scale (Pain-NRS) | Visits 2 (Week 0) and up to visit 11 (Week 60) | Efficacy of ritlecitinib measured by Pain-NRS. The NRS will range from 0 (no symptoms) to 10 (severe symptoms). Patients indicate the intensity of pain by choosing a number from 0 (no pain) to 10 (worst imaginable pain) that corresponds to the severity of that symptom, with higher scores indicating higher levels of pain. |
| Secondary | Change in Itch-NRS | Visits 2 (Week 0) and up to visit 11 (Week 60) | Efficacy of ritlecitinib measured by Itch-NRS. The NRS will range from 0 (no symptoms) to 10 (severe symptoms). Patients indicate the intensity of itch by choosing a number from 0 to 10 that corresponds to the severity of that symptom. Scale 0-10 0 = No Itch 10 = Worst Itch Imaginable Higher scores indicate greater itch severity. |
| Secondary | Change in PGIC (Patient Global Impression of Change) | Visits 2 (Week 0) and up to visit 11 (Week 60) | Efficacy of ritlecitinib measured by Patient Global Impression of Change (PGIC). The PGIC will be used to assess self-reported relieving effect. It will evaluate pain from no change (score 0-1), minimally improved (score 2-3), much improved (score 4-5), and very much improved (score 6-7). Total Scale from 0-87. Higher scores indicate more favorable health outcomes. Patients will be asked to choose ONE: * No change (or condition has gotten worse) (1) * Almost the same, hardly any change at all (2) * A little better, but no noticeable change (3) * Somewhat better, but the change has not made any real difference (4) * Moderately better, and a slight but noticeable change (5) * Better and a definite improvement that has made a real and worthwhile difference (6) * A great deal better and a considerable improvement that has made all the difference (7) |
| Secondary | Change in DLQI (Dermatology Life Quality Index) | Visits 2 (Week 0) and up to visit 11 (Week 60) | Efficacy of ritlecitinib measured by Dermatology Life Quality Index (DLQI). DLQI is a 10-item questionnaire, each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), thus, higher scores indicate greater impairment. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06373458
GET https://conductscience.org/api/trials/v1/NCT06373458/registered