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.
This study is a prospective, two-arm, open-label clinical trial to investigate efficacy and safety of ritlecitinib in patients with keloid. The study will take place at Icahn School of Medicine at Mount Sinai. The study will consist of 2 arms: a total of 20 patients receiving keloidectomy and 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. Patients will be treated with ritlecitinib 50 mg QD for 36 weeks starting at Day 1. Participants will attend clinic visits at Weeks 2, 4, 8, 12, 20, 28, and 36 for assessments, questionnaires and safety laboratory tests. The follow-up period will be 6 months, with clinic visits at Weeks 48 and 60.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Ritlecitinib 50mg QD for 36 weeks starting at Day 1
Icahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITINGRecurrence Rate
Recurrence Rate at 9 months (Visit 9) in subjects that received keloidectomy
Time frame: at 9 months (Visit 9)
Change in Detroid Keloid Scale Score
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.
Time frame: Baseline and 9 months (Visit 9)
Change in Peak keloid tension
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".
Time frame: Visits 2 (Week 0) and up to visit 11 (Week 60)
Change in Detroid Keloid Scale Score (DKS)
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.
Time frame: Visits 2 (Week 0) and up to visit 11 (Week 60)
Change in Pain Numerical Rating Scale (Pain-NRS)
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.
Time frame: Visits 2 (Week 0) and up to visit 11 (Week 60)
Change in Itch-NRS
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.
Time frame: Visits 2 (Week 0) and up to visit 11 (Week 60)
Change in PGIC (Patient Global Impression of Change)
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)
Time frame: Visits 2 (Week 0) and up to visit 11 (Week 60)
Change in DLQI (Dermatology Life Quality Index)
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.
Time frame: Visits 2 (Week 0) and up to visit 11 (Week 60)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.