Ruxolitinib Cream in the Treatment of Cutaneous Necrobiosis Lipoidica

This research study is evaluating the safety and efficacy of a topical drug treatment "Ruxolitinib" in treating Necrobiosis Lipoidica (NL).

Study Overview

• Status: Completed
• Conditions: Necrobiosis Lipoidica
• Intervention / Treatment: Drug: Ruxolitinib

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects must be able to understand and comply with the requirements of the study and communicate with the investigator. Subjects must give written, signed, and dated informed consent before any study related activity is performed. When appropriate, a legal representative will sign the informed consent according to local laws and regulation
• Both men and women must be at least 18 years of age at the time of screening
• Subjects must have clinical and histological features of NL
• Subjects must have at least one NL lesion measuring at least 1.7 cm
• NL must not affect greater than 10% BSA

Exclusion Criteria:

• On excluded therapies, not on a stable dose of a therapy, or incompletely washed out for a therapy (Table-1).
• Known hypersensitivity to Ruxolitinib formulation.
• Pregnant or nursing (lactating) women (pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test).

• Women of childbearing potential [Post-menopausal or not of child-bearing potential is defined by: 1 year of natural (spontaneous) amenorrhea or Surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks ago. Oophorectomy alone must be confirmed by follow up hormone level assessment to be considered not of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using medically acceptable methods of contraception which includes:

  • Total abstinence (periodic abstinence and withdrawal are not acceptable methods of contraception).
  • Female sterilization (bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment. Oophorectomy alone requires follow up hormone level assessment for fertility.
  • Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject.
  • Barrier methods of contraception: condom or occlusive cap.
  • Use of oral, injected or implanted hormonal methods of contraception or other forms or hormonal contraception that have complete efficacy (failure <1%). (The dose of the contraceptive should be stable for 3 months).
• Active ongoing inflammatory diseases of the skin other than NL that might confound the evaluation of the benefit of ruxolitinib cream.
• Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions) which, in the opinion of the investigator, significantly immunocompromised the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.
• Active systemic infections during the 2 weeks prior to randomization (common cold viruses not included) or any infection that reoccurs on a regular basis.
• Current severe progressive or uncontrolled disease which the investigator renders the subject unsuitable for the trial or puts the subject at increased risk.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Necrobiosis Lipoidica; Adults with cutaneous Necrobiosis Lipoidica (NL) up to 10% of the body surface area (BSA) treated with Ruxolitinib cream	Drug: Ruxolitinib; Ruxolitinib cream 1.5%, topical application will be used twice daily on lesions of Necrobiosis Lipoidica

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Necrobiosis Lipoidica (NL) Lesion Score	The NL skin scoring system examines the index treatment lesion on a scale from 0 (none) to 3 (severe) for each of the following areas: erythema, infiltration, ulceration, and pain. A total possible score of 0-12, with lower scores indicating none and higher scores indicating more severe.	Baseline, week 12

Collaborators and Investigators

• Sponsor: Aaron R. Mangold

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 29, 2020
• Primary Completion (ACTUAL): March 16, 2022
• Study Completion (ACTUAL): March 16, 2022

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (ACTUAL): July 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Skin Diseases; Connective Tissue Diseases; Collagen Diseases; Skin Diseases, Metabolic; Necrobiosis Lipoidica; Necrobiotic Disorders
• Other Study ID Numbers: 19-004087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No