Ruxolitinib Cream in the Treatment of Cutaneous Necrobiosis Lipoidica

NCT ID: NCT04492618

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-29
• Study Completion Date: 2022-03-16

Brief Summary

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

Conditions

Necrobiosis Lipoidica

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Necrobiosis Lipoidica

Adults with cutaneous Necrobiosis Lipoidica (NL) up to 10% of the body surface area (BSA) treated with Ruxolitinib cream

Group Type: EXPERIMENTAL

Ruxolitinib

Intervention Type: DRUG

Ruxolitinib cream 1.5%, topical application will be used twice daily on lesions of Necrobiosis Lipoidica

Interventions

Ruxolitinib

Ruxolitinib cream 1.5%, topical application will be used twice daily on lesions of Necrobiosis Lipoidica

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aaron R. Mangold

OTHER

Sponsor Role: lead

Responsible Party

Aaron R. Mangold

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Aaron R Mangold

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

19-004087

Identifier Type: -

Identifier Source: org_study_id