18 and older, female only, with Lichen Sclerosus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With ITCH4 at Week 12Primary· Baseline; 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.
Group
Value
95% CI
DBVC Period: Ruxolitinib Cream 1.5% BID
35.7
18.6 – 55.9
DBVC Period: Vehicle Cream BID
40.0
22.7 – 59.4
Change From Baseline in the Clinical Lichen Sclerosus Score (CLISSCO) at Week 12Secondary· Baseline; Week 12
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 sc
Group
Value
95% CI
DBVC Period: Ruxolitinib Cream 1.5% BID
-5.79
± 0.80
DBVC Period: Vehicle Cream BID
-3.03
± 0.82
Change From Baseline in the Skin Pain NRS Score at Week 12Secondary· Baseline; Week 12
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.
Group
Value
95% CI
DBVC Period: Ruxolitinib Cream 1.5% BID
-3.22
± 0.50
DBVC Period: Vehicle Cream BID
-2.70
± 0.52
Time to Achieve ITCH4Secondary· up to 99.0 days
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.
Group
Value
95% CI
DBVC Period: Ruxolitinib Cream 1.5% BID
35.0
7.0 – 57.0
DBVC Period: Vehicle Cream BID
28.0
6.0 – NA
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled PeriodSecondary· from Baseline to Week 12 plus 30 days
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.
Group
Value
95% CI
DBVC Period: Ruxolitinib Cream 1.5% BID
14
DBVC Period: Vehicle Cream BID
12
Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled PeriodSecondary· from Baseline to Week 12 plus 30 days
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 treatmen
Group
Value
95% CI
DBVC Period: Ruxolitinib Cream 1.5% BID
1
DBVC Period: Vehicle Cream BID
0
Number of Participants With Any TEAE During the Open-label Extension PeriodSecondary· from Week 12 to Week 24 plus 30 days
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.
Group
Value
95% CI
DBVC Period: Ruxolitinib Cream 1.5% BID
13
DBVC Period: Vehicle Cream BID
11
Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension PeriodSecondary· from Week 12 to Week 24 plus 30 days
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 livin
Group
Value
95% CI
DBVC Period: Ruxolitinib Cream 1.5% BID
1
DBVC Period: Vehicle Cream BID
0
Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Double-blind, Vehicle-controlled PeriodSecondary· from Baseline to Week 12 plus 30 days
The investigator determined if a clinical laboratory test value was clinically meaningful.
Group
Value
95% CI
DBVC Period: Ruxolitinib Cream 1.5% BID
0
DBVC Period: Vehicle Cream BID
0
Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Double-blind, Vehicle-controlled PeriodSecondary· from Baseline to Week 12 plus 30 days
The investigator determined if a clinical laboratory test value was clinically meaningful.
Group
Value
95% CI
DBVC Period: Ruxolitinib Cream 1.5% BID
0
DBVC Period: Vehicle Cream BID
0
Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Open-label Extension PeriodSecondary· from Week 12 to Week 24 plus 30 days
The investigator determined if a clinical laboratory test value was clinically meaningful.
Group
Value
95% CI
DBVC Period: Ruxolitinib Cream 1.5% BID
0
DBVC Period: Vehicle Cream BID
0
Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Open-label Extension PeriodSecondary· from Week 12 to Week 24 plus 30 days
The investigator determined if a clinical laboratory test value was clinically meaningful.
Group
Value
95% CI
DBVC Period: Ruxolitinib Cream 1.5% BID
0
DBVC Period: Vehicle Cream BID
0
Adverse events — posted to ClinicalTrials.gov
Time frame: up to approximately 32 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants With Lichen Sclerosus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 12 weeks followed by an open label period (OLE) period of 12 weeks.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05906628 — Topical Ruxolitinib Evaluation in Chronic Hand Eczema
· Phase 2
· completed
NCT05233410 — Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 2
· Phase 3
· withdrawn
NCT05219864 — Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1
· Phase 3
· withdrawn
NCT05635838 — Study to Evaluate of the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
· Phase 2
· completed
NCT05593432 — A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus
· Phase 2
· completed
Other recruiting trials for Lichen Sclerosus
Currently open trials in the same condition.
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· NA
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Incyte Corporation
Last refreshed: 24 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05593445.