Ruxolitinib Cream in the Treatment of Cutaneous Necrobiosis Lipoidica

Sponsor

Aaron R. Mangold (Other)

Overall Status

Completed

CT.gov ID

NCT04492618

Collaborator

(none)

Enrollment

Location

Arm

17.5

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Necrobiosis Lipoidica	Drug: Ruxolitinib	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Ruxolitinib Cream in the Treatment of Cutaneous Necrobiosis Lipoidica

Actual Study Start Date :

Sep 29, 2020

Actual Primary Completion Date :

Mar 16, 2022

Actual Study Completion Date :

Mar 16, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Necrobiosis Lipoidica (NL) Score [Baseline, week 12]
Measured using NL score (0-12) of the index treatment lesions

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259

Sponsors and Collaborators

Aaron R. Mangold

Investigators

Principal Investigator: Aaron R Mangold, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Aaron R. Mangold, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT04492618

Other Study ID Numbers:

19-004087

First Posted:

Jul 30, 2020

Last Update Posted:

Mar 21, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Necrobiosis Lipoidica

Necrobiotic Disorders

Study Results

No Results Posted as of Mar 21, 2022