Ruxolitinib Cream in the Treatment of Cutaneous Necrobiosis Lipoidica
Condition: Necrobiosis Lipoidica
MeSH terms: Necrobiosis Lipoidica; Necrobiotic Disorders
Intervention: Ruxolitinib
Intervention description: Ruxolitinib cream 1.5%, topical application will be used twice daily on lesions of Necrobiosis Lipoidica
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

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.