Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus (NCT NCT05593445)
NCT ID: NCT05593445
Last Updated: 2024-09-24
Results Overview
ITCH4 response was defined as a ≥4-point improvement from Baseline in by-visit Itch Numeric Rating Scale (NRS) score. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants rated itch severity of their lichen sclerosus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.
COMPLETED
PHASE2
61 participants
Baseline; Week 12
2024-09-24
Participant Flow
A total of 61 participants were randomized into the study. All randomized participants (Intent-to-Treat Population) applied study drug at least once (Safety Population), and 56 participants applied ruxolitinib 1.5% cream at least once during the Open-label Extension (OLE) Period (OLE-Evaluable Population).
Participant milestones
| Measure |
Double-Blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib Cream 1.5% BID
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 12 weeks.
|
DBVC Period: Vehicle Cream BID
Participants applied matching vehicle cream BID for 12 weeks.
|
Open-Label Extension Period: Ruxolitinib Cream 1.5% BID
Participants who completed the Week 12 assessments with no safety concerns could continue into the 12-week Open-label Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-blind, Vehicle-controlled Period continued to apply ruxolitinib cream 1.5% BID for an additional 12 weeks in the Open-label Extension Period. Participants could have cycled between once daily (QD) or BID application of ruxolitinib 1.5% cream based on the investigator's clinical judgment of disease activity.
|
Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID
Participants who completed the Week 12 assessments with no safety concerns could continue into the 12-week Open-label Extension Period. Participants who applied vehicle cream BID during the Double-blind, Vehicle-controlled Period applied ruxolitinib cream 1.5% BID for 12 weeks in the Open-label Extension Period. Participants could have cycled between QD or BID application of ruxolitinib 1.5% cream based on the investigator's clinical judgment of disease activity.
|
|---|---|---|---|---|
|
12-Week DBVC Period
STARTED
|
31
|
30
|
0
|
0
|
|
12-Week DBVC Period
COMPLETED
|
29
|
27
|
0
|
0
|
|
12-Week DBVC Period
NOT COMPLETED
|
2
|
3
|
0
|
0
|
|
12-Week Open-Label Extension Period
STARTED
|
0
|
0
|
29
|
27
|
|
12-Week Open-Label Extension Period
COMPLETED
|
0
|
0
|
26
|
25
|
|
12-Week Open-Label Extension Period
NOT COMPLETED
|
0
|
0
|
3
|
2
|
Reasons for withdrawal
| Measure |
Double-Blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib Cream 1.5% BID
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 12 weeks.
|
DBVC Period: Vehicle Cream BID
Participants applied matching vehicle cream BID for 12 weeks.
|
Open-Label Extension Period: Ruxolitinib Cream 1.5% BID
Participants who completed the Week 12 assessments with no safety concerns could continue into the 12-week Open-label Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-blind, Vehicle-controlled Period continued to apply ruxolitinib cream 1.5% BID for an additional 12 weeks in the Open-label Extension Period. Participants could have cycled between once daily (QD) or BID application of ruxolitinib 1.5% cream based on the investigator's clinical judgment of disease activity.
|
Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID
Participants who completed the Week 12 assessments with no safety concerns could continue into the 12-week Open-label Extension Period. Participants who applied vehicle cream BID during the Double-blind, Vehicle-controlled Period applied ruxolitinib cream 1.5% BID for 12 weeks in the Open-label Extension Period. Participants could have cycled between QD or BID application of ruxolitinib 1.5% cream based on the investigator's clinical judgment of disease activity.
|
|---|---|---|---|---|
|
12-Week DBVC Period
Adverse Event
|
1
|
0
|
0
|
0
|
|
12-Week DBVC Period
Physician Decision
|
0
|
1
|
0
|
0
|
|
12-Week DBVC Period
Protocol Violation
|
0
|
1
|
0
|
0
|
|
12-Week DBVC Period
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
12-Week DBVC Period
Did Not Meet Eligibility Criteria
|
1
|
0
|
0
|
0
|
|
12-Week Open-Label Extension Period
Adverse Event
|
0
|
0
|
1
|
1
|
|
12-Week Open-Label Extension Period
Lost to Follow-up
|
0
|
0
|
1
|
1
|
|
12-Week Open-Label Extension Period
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus
Baseline characteristics by cohort
| Measure |
DBVC Period: Ruxolitinib Cream 1.5% BID
n=31 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 12 weeks.
|
DBVC Period: Vehicle Cream BID
n=30 Participants
Participants applied matching vehicle cream BID for 12 weeks.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 11.28 • n=5 Participants
|
61.9 years
STANDARD_DEVIATION 12.25 • n=7 Participants
|
60.9 years
STANDARD_DEVIATION 11.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 12Population: Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups were defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might have taken. Only those participants with a Baseline ITCH NRS Score ≥4 were analyzed. Missing post-baseline values were imputed as Non-Responders at Week 12.
ITCH4 response was defined as a ≥4-point improvement from Baseline in by-visit Itch Numeric Rating Scale (NRS) score. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants rated itch severity of their lichen sclerosus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.
Outcome measures
| Measure |
DBVC Period: Ruxolitinib Cream 1.5% BID
n=28 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 12 weeks.
|
DBVC Period: Vehicle Cream BID
n=30 Participants
Participants applied matching vehicle cream BID for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With ITCH4 at Week 12
|
35.7 percentage of participants
Interval 18.6 to 55.9
|
40.0 percentage of participants
Interval 22.7 to 59.4
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: ITT Population. Only participants with available data were analyzed. Mixed Model Repeated Measures (MMRM) model: response variable = treatment + visit + treatment by visit.
The CLISSCO is a validated tool to assess disease severity in vulvar lichen sclerosus. The Clinical Lichen Sclerosus Score consists of 12 items divided into 3 sections: symptoms (3 items; likely reversible \[i.e., itch, pain, dysuria\]); signs (3 items; possibly reversible \[i.e., whitening, petechiae/ecchymosis, fissures\]); and architectural changes (6 items; irreversible \[i.e., skin fusion, perianal involvement, etc.\]). All symptoms, signs, and architectural changes were rated on a 4-point Likert scale: 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). The investigator documented the score of each of the 12 items; the CLISSCO was calculated by summing the score of each question, with a maximum score of 36 and a minimum score of 0. The higher the score, the more severe the disease. Additionally, the total score for each of the 3 sections (symptoms, signs, and architectural changes) was summarized by summing the scores of the questions in each section.
Outcome measures
| Measure |
DBVC Period: Ruxolitinib Cream 1.5% BID
n=29 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 12 weeks.
|
DBVC Period: Vehicle Cream BID
n=27 Participants
Participants applied matching vehicle cream BID for 12 weeks.
|
|---|---|---|
|
Change From Baseline in the Clinical Lichen Sclerosus Score (CLISSCO) at Week 12
|
-5.79 scores on a scale
Standard Error 0.80
|
-3.03 scores on a scale
Standard Error 0.82
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: ITT Population. Only participants with available data were analyzed. No imputation was performed for missing values. MMRM model: response variable = treatment + visit + treatment by visit.
Participants were instructed to complete and record the Skin Pain NRS in a diary each evening beginning on the day of screening through Week 12 or treatment discontinuation. Participants rated their pain, which included all types of pain (e.g., burning, tearing, pulling, stabbing, etc.) severity of lichen sclerosus by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described the worst level of pain they experienced in the past 24 hours.
Outcome measures
| Measure |
DBVC Period: Ruxolitinib Cream 1.5% BID
n=29 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 12 weeks.
|
DBVC Period: Vehicle Cream BID
n=26 Participants
Participants applied matching vehicle cream BID for 12 weeks.
|
|---|---|---|
|
Change From Baseline in the Skin Pain NRS Score at Week 12
|
-3.22 scores on a scale
Standard Error 0.50
|
-2.70 scores on a scale
Standard Error 0.52
|
SECONDARY outcome
Timeframe: up to 99.0 daysPopulation: ITT Population. Only those participants achieving a ≥4-point improvement in daily Itch NRS score from Baseline were analyzed.
ITCH4 response was defined as a ≥4-point improvement from Baseline in by-visit Itch Numeric Rating Scale (NRS) score. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants rated itch severity of their lichen sclerosus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.
Outcome measures
| Measure |
DBVC Period: Ruxolitinib Cream 1.5% BID
n=18 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 12 weeks.
|
DBVC Period: Vehicle Cream BID
n=18 Participants
Participants applied matching vehicle cream BID for 12 weeks.
|
|---|---|---|
|
Time to Achieve ITCH4
|
35.0 days
Interval 7.0 to 57.0
|
28.0 days
Interval 6.0 to
The upper limit of the confidence interval was not evaluable because there were too few participants with events.
|
SECONDARY outcome
Timeframe: from Baseline to Week 12 plus 30 daysPopulation: Safety Population: all participants who applied ruxolitinib 1.5% cream or vehicle cream at least once. Treatment groups for this population were determined according to the actual treatment the participant applied on Day 1 regardless of assigned treatment group.
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug.
Outcome measures
| Measure |
DBVC Period: Ruxolitinib Cream 1.5% BID
n=31 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 12 weeks.
|
DBVC Period: Vehicle Cream BID
n=30 Participants
Participants applied matching vehicle cream BID for 12 weeks.
|
|---|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period
|
14 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: from Baseline to Week 12 plus 30 daysPopulation: Safety Population
A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0) Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Outcome measures
| Measure |
DBVC Period: Ruxolitinib Cream 1.5% BID
n=31 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 12 weeks.
|
DBVC Period: Vehicle Cream BID
n=30 Participants
Participants applied matching vehicle cream BID for 12 weeks.
|
|---|---|---|
|
Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from Week 12 to Week 24 plus 30 daysPopulation: Open-label Extension Evaluable Population: all participants who applied ruxolitinib 1.5% cream at least once during the Open-label Extension Period
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug.
Outcome measures
| Measure |
DBVC Period: Ruxolitinib Cream 1.5% BID
n=29 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 12 weeks.
|
DBVC Period: Vehicle Cream BID
n=27 Participants
Participants applied matching vehicle cream BID for 12 weeks.
|
|---|---|---|
|
Number of Participants With Any TEAE During the Open-label Extension Period
|
13 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: from Week 12 to Week 24 plus 30 daysPopulation: Open-label Extension Evaluable Population
A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using the CTCAE v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Outcome measures
| Measure |
DBVC Period: Ruxolitinib Cream 1.5% BID
n=29 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 12 weeks.
|
DBVC Period: Vehicle Cream BID
n=27 Participants
Participants applied matching vehicle cream BID for 12 weeks.
|
|---|---|---|
|
Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from Baseline to Week 12 plus 30 daysPopulation: Safety Population
The investigator determined if a clinical laboratory test value was clinically meaningful.
Outcome measures
| Measure |
DBVC Period: Ruxolitinib Cream 1.5% BID
n=31 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 12 weeks.
|
DBVC Period: Vehicle Cream BID
n=30 Participants
Participants applied matching vehicle cream BID for 12 weeks.
|
|---|---|---|
|
Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Double-blind, Vehicle-controlled Period
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from Baseline to Week 12 plus 30 daysPopulation: Safety Population
The investigator determined if a clinical laboratory test value was clinically meaningful.
Outcome measures
| Measure |
DBVC Period: Ruxolitinib Cream 1.5% BID
n=31 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 12 weeks.
|
DBVC Period: Vehicle Cream BID
n=30 Participants
Participants applied matching vehicle cream BID for 12 weeks.
|
|---|---|---|
|
Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Double-blind, Vehicle-controlled Period
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from Week 12 to Week 24 plus 30 daysPopulation: Open-label Extension Evaluable Population
The investigator determined if a clinical laboratory test value was clinically meaningful.
Outcome measures
| Measure |
DBVC Period: Ruxolitinib Cream 1.5% BID
n=29 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 12 weeks.
|
DBVC Period: Vehicle Cream BID
n=27 Participants
Participants applied matching vehicle cream BID for 12 weeks.
|
|---|---|---|
|
Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Open-label Extension Period
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from Week 12 to Week 24 plus 30 daysPopulation: Open-label Extension Evaluable Population
The investigator determined if a clinical laboratory test value was clinically meaningful.
Outcome measures
| Measure |
DBVC Period: Ruxolitinib Cream 1.5% BID
n=29 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 12 weeks.
|
DBVC Period: Vehicle Cream BID
n=27 Participants
Participants applied matching vehicle cream BID for 12 weeks.
|
|---|---|---|
|
Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Open-label Extension Period
|
0 Participants
|
0 Participants
|
Adverse Events
Ruxolitinib Cream 1.5% BID
Vehicle Cream BID
Serious adverse events
| Measure |
Ruxolitinib Cream 1.5% BID
n=58 participants at risk
Participants who completed the Week 12 assessments with no safety concerns, continued into the 12-week Open-label Extension Period, and applied ruxolitinib cream 1.5% BID for 12 weeks in the Open-label Extension Period.
|
Vehicle Cream BID
n=30 participants at risk
Participants applied matching vehicle cream twice a day (BID) for 12 weeks in the Double-Blind Period.
|
|---|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/58 • up to approximately 32 weeks
For safety analysis, participants who transitioned from treatment with vehicle to treatment with 1.5% BID ruxolitinib cream in the the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
3.3%
1/30 • Number of events 1 • up to approximately 32 weeks
For safety analysis, participants who transitioned from treatment with vehicle to treatment with 1.5% BID ruxolitinib cream in the the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
Other adverse events
| Measure |
Ruxolitinib Cream 1.5% BID
n=58 participants at risk
Participants who completed the Week 12 assessments with no safety concerns, continued into the 12-week Open-label Extension Period, and applied ruxolitinib cream 1.5% BID for 12 weeks in the Open-label Extension Period.
|
Vehicle Cream BID
n=30 participants at risk
Participants applied matching vehicle cream twice a day (BID) for 12 weeks in the Double-Blind Period.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
3.4%
2/58 • Number of events 2 • up to approximately 32 weeks
For safety analysis, participants who transitioned from treatment with vehicle to treatment with 1.5% BID ruxolitinib cream in the the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
6.7%
2/30 • Number of events 2 • up to approximately 32 weeks
For safety analysis, participants who transitioned from treatment with vehicle to treatment with 1.5% BID ruxolitinib cream in the the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
|
Infections and infestations
Nasopharyngitis
|
5.2%
3/58 • Number of events 3 • up to approximately 32 weeks
For safety analysis, participants who transitioned from treatment with vehicle to treatment with 1.5% BID ruxolitinib cream in the the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
10.0%
3/30 • Number of events 3 • up to approximately 32 weeks
For safety analysis, participants who transitioned from treatment with vehicle to treatment with 1.5% BID ruxolitinib cream in the the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
1/58 • Number of events 1 • up to approximately 32 weeks
For safety analysis, participants who transitioned from treatment with vehicle to treatment with 1.5% BID ruxolitinib cream in the the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
6.7%
2/30 • Number of events 2 • up to approximately 32 weeks
For safety analysis, participants who transitioned from treatment with vehicle to treatment with 1.5% BID ruxolitinib cream in the the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
|
Infections and infestations
Urinary tract infection
|
6.9%
4/58 • Number of events 5 • up to approximately 32 weeks
For safety analysis, participants who transitioned from treatment with vehicle to treatment with 1.5% BID ruxolitinib cream in the the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
0.00%
0/30 • up to approximately 32 weeks
For safety analysis, participants who transitioned from treatment with vehicle to treatment with 1.5% BID ruxolitinib cream in the the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
5.2%
3/58 • Number of events 3 • up to approximately 32 weeks
For safety analysis, participants who transitioned from treatment with vehicle to treatment with 1.5% BID ruxolitinib cream in the the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
0.00%
0/30 • up to approximately 32 weeks
For safety analysis, participants who transitioned from treatment with vehicle to treatment with 1.5% BID ruxolitinib cream in the the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER