| Eligibility |
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.
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