Trial Outcomes & Findings for Ruxolitinib Cream in the Treatment of Cutaneous Necrobiosis Lipoidica (NCT NCT04492618)
NCT ID: NCT04492618
Last Updated: 2023-02-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Baseline, week 12
Results posted on
2023-02-08
Participant Flow
Participant milestones
| Measure |
Necrobiosis Lipoidica
Adults with cutaneous Necrobiosis Lipoidica (NL) up to 10% of the body surface area (BSA) were treated with Ruxolitinib cream
Ruxolitinib: Ruxolitinib cream 1.5%, topical application was used twice daily on lesions of Necrobiosis Lipoidica
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Necrobiosis Lipoidica
Adults with cutaneous Necrobiosis Lipoidica (NL) up to 10% of the body surface area (BSA) were treated with Ruxolitinib cream
Ruxolitinib: Ruxolitinib cream 1.5%, topical application was used twice daily on lesions of Necrobiosis Lipoidica
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Ruxolitinib Cream in the Treatment of Cutaneous Necrobiosis Lipoidica
Baseline characteristics by cohort
| Measure |
Necrobiosis Lipoidica
n=12 Participants
Adults with cutaneous Necrobiosis Lipoidica (NL) up to 10% of the body surface area (BSA) were treated with Ruxolitinib cream
Ruxolitinib: Ruxolitinib cream 1.5%, topical application was used twice daily on lesions of Necrobiosis Lipoidica
|
|---|---|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 12Population: 1 Subject withdrew. Week 12 data was not collected nor analyzed
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.
Outcome measures
| Measure |
Necrobiosis Lipoidica
n=11 Participants
Adults with cutaneous Necrobiosis Lipoidica (NL) up to 10% of the body surface area (BSA) were treated with Ruxolitinib cream
Ruxolitinib: Ruxolitinib cream 1.5%, topical application was used twice daily on lesions of Necrobiosis Lipoidica
|
|---|---|
|
Change in Mean Necrobiosis Lipoidica (NL) Lesion Score
|
-2.7 score on a scale
Standard Deviation 1.6
|
Adverse Events
Necrobiosis Lipoidica
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Necrobiosis Lipoidica
n=12 participants at risk
Adults with cutaneous Necrobiosis Lipoidica (NL) up to 10% of the body surface area (BSA) were treated with Ruxolitinib cream
Ruxolitinib: Ruxolitinib cream 1.5%, topical application was used twice daily on lesions of Necrobiosis Lipoidica
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Adverse events were collected for all subjects from baseline to end of study, approximately 16 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcimona removal
|
8.3%
1/12 • Adverse events were collected for all subjects from baseline to end of study, approximately 16 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
8.3%
1/12 • Adverse events were collected for all subjects from baseline to end of study, approximately 16 weeks.
|
|
Skin and subcutaneous tissue disorders
Burning sensation
|
8.3%
1/12 • Adverse events were collected for all subjects from baseline to end of study, approximately 16 weeks.
|
|
Skin and subcutaneous tissue disorders
Burning sensation on NL spots
|
8.3%
1/12 • Adverse events were collected for all subjects from baseline to end of study, approximately 16 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cold Symptoms
|
8.3%
1/12 • Adverse events were collected for all subjects from baseline to end of study, approximately 16 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Adverse events were collected for all subjects from baseline to end of study, approximately 16 weeks.
|
|
Musculoskeletal and connective tissue disorders
Heaviness Bilateral legs
|
8.3%
1/12 • Adverse events were collected for all subjects from baseline to end of study, approximately 16 weeks.
|
|
Skin and subcutaneous tissue disorders
Heightened sensitivity on lesions
|
8.3%
1/12 • Adverse events were collected for all subjects from baseline to end of study, approximately 16 weeks.
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
8.3%
1/12 • Adverse events were collected for all subjects from baseline to end of study, approximately 16 weeks.
|
|
Musculoskeletal and connective tissue disorders
Lower extremity aches
|
8.3%
1/12 • Adverse events were collected for all subjects from baseline to end of study, approximately 16 weeks.
|
|
General disorders
Nausea
|
8.3%
1/12 • Adverse events were collected for all subjects from baseline to end of study, approximately 16 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • Adverse events were collected for all subjects from baseline to end of study, approximately 16 weeks.
|
|
Musculoskeletal and connective tissue disorders
Tingling feeling left shin
|
8.3%
1/12 • Adverse events were collected for all subjects from baseline to end of study, approximately 16 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place