Trial · NCT05593445
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus
NCT05593445, Phase 2, Completed, Incyte Corporation; results first posted 2024-09-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus. Trials, record NCT05593445. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05593445
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus
- NCT number
- NCT05593445
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 61 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Lichen Sclerosus
- Interventions
- Ruxolitinib cream, Vehicle cream
- First posted
- 2022-10-25
- Last updated
- 2024-09-24
- Results first posted
- 2024-09-24
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With ITCH4 at Week 12 | 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. |
| Secondary | Change From Baseline in the Clinical Lichen Sclerosus Score (CLISSCO) at Week 12 | 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 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. |
| Secondary | Change From Baseline in the Skin Pain NRS Score at Week 12 | 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. |
| Secondary | Time to Achieve ITCH4 | 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. |
| Secondary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period | 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. |
| Secondary | Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period | 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 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. |
| Secondary | Number of Participants With Any TEAE During the Open-label Extension Period | 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. |
| Secondary | Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period | 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 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. |
| Secondary | Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Double-blind, Vehicle-controlled Period | from Baseline to Week 12 plus 30 days | The investigator determined if a clinical laboratory test value was clinically meaningful. |
| Secondary | Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Double-blind, Vehicle-controlled Period | from Baseline to Week 12 plus 30 days | The investigator determined if a clinical laboratory test value was clinically meaningful. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With ITCH4 at Week 12 | Baseline; Week 12 | 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. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the Clinical Lichen Sclerosus Score (CLISSCO) at Week 12 | Baseline; Week 12 | ITT Population. Only participants with available data were analyzed. Mixed Model Repeated Measures (MMRM) model: response variable = treatment + visit + treatment by visit. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Skin Pain NRS Score at Week 12 | Baseline; Week 12 | 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. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Achieve ITCH4 | up to 99.0 days | ITT Population. Only those participants achieving a ≥4-point improvement in daily Itch NRS score from Baseline were analyzed. | days | MEDIAN |
| SECONDARY | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period | from Baseline to Week 12 plus 30 days | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period | from Baseline to Week 12 plus 30 days | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any TEAE During the Open-label Extension Period | from Week 12 to Week 24 plus 30 days | Open-label Extension Evaluable Population: all participants who applied ruxolitinib 1.5% cream at least once during the Open-label Extension Period | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period | from Week 12 to Week 24 plus 30 days | Open-label Extension Evaluable Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Double-blind, Vehicle-controlled Period | from Baseline to Week 12 plus 30 days | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Double-blind, Vehicle-controlled Period | from Baseline to Week 12 plus 30 days | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With ITCH4 at Week 12 | DBVC Period: Ruxolitinib Cream 1.5% BID | 35.7 | 95% Confidence Interval 18.6 to 55.9 | percentage of participants | |
| Percentage of Participants With ITCH4 at Week 12 | DBVC Period: Vehicle Cream BID | 40.0 | 95% Confidence Interval 22.7 to 59.4 | percentage of participants | |
| Change From Baseline in the Clinical Lichen Sclerosus Score (CLISSCO) at Week 12 | DBVC Period: Ruxolitinib Cream 1.5% BID | -5.79 | Standard Error 0.80 | scores on a scale | |
| Change From Baseline in the Clinical Lichen Sclerosus Score (CLISSCO) at Week 12 | DBVC Period: Vehicle Cream BID | -3.03 | Standard Error 0.82 | scores on a scale | |
| Change From Baseline in the Skin Pain NRS Score at Week 12 | DBVC Period: Ruxolitinib Cream 1.5% BID | -3.22 | Standard Error 0.50 | scores on a scale | |
| Change From Baseline in the Skin Pain NRS Score at Week 12 | DBVC Period: Vehicle Cream BID | -2.70 | Standard Error 0.52 | scores on a scale | |
| Time to Achieve ITCH4 | DBVC Period: Ruxolitinib Cream 1.5% BID | 35.0 | 95% Confidence Interval 7.0 to 57.0 | days | |
| Time to Achieve ITCH4 | DBVC Period: Vehicle Cream BID | 28.0 | 95% Confidence Interval 6.0 to NA | days | |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period | DBVC Period: Ruxolitinib Cream 1.5% BID | 14 | Participants | ||
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period | DBVC Period: Vehicle Cream BID | 12 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 12-Week DBVC Period | STARTED | Double-Blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib Cream 1.5% BID | 31 | |
| 12-Week DBVC Period | STARTED | DBVC Period: Vehicle Cream BID | 30 | |
| 12-Week DBVC Period | STARTED | Open-Label Extension Period: Ruxolitinib Cream 1.5% BID | 0 | |
| 12-Week DBVC Period | STARTED | Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID | 0 | |
| 12-Week DBVC Period | COMPLETED | Double-Blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib Cream 1.5% BID | 29 | |
| 12-Week DBVC Period | COMPLETED | DBVC Period: Vehicle Cream BID | 27 | |
| 12-Week DBVC Period | COMPLETED | Open-Label Extension Period: Ruxolitinib Cream 1.5% BID | 0 | |
| 12-Week DBVC Period | COMPLETED | Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID | 0 | |
| 12-Week DBVC Period | NOT COMPLETED | Double-Blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib Cream 1.5% BID | 2 | |
| 12-Week DBVC Period | NOT COMPLETED | DBVC Period: Vehicle Cream BID | 3 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Ruxolitinib Cream 1.5% BID | 2 | 58 | 2 |
| other | COVID-19 | Infections and infestations | Vehicle Cream BID | 2 | 30 | 2 |
| other | Nasopharyngitis | Infections and infestations | Ruxolitinib Cream 1.5% BID | 3 | 58 | 3 |
| other | Nasopharyngitis | Infections and infestations | Vehicle Cream BID | 3 | 30 | 3 |
| other | Upper respiratory tract infection | Infections and infestations | Ruxolitinib Cream 1.5% BID | 1 | 58 | 1 |
| other | Upper respiratory tract infection | Infections and infestations | Vehicle Cream BID | 2 | 30 | 2 |
| other | Urinary tract infection | Infections and infestations | Ruxolitinib Cream 1.5% BID | 4 | 58 | 5 |
| other | Urinary tract infection | Infections and infestations | Vehicle Cream BID | 0 | 30 | 0 |
| other | Vulvovaginal mycotic infection | Infections and infestations | Ruxolitinib Cream 1.5% BID | 3 | 58 | 3 |
| other | Vulvovaginal mycotic infection | Infections and infestations | Vehicle Cream BID | 0 | 30 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ruxolitinib Cream 1.5% BID | 0 | 58 |
| Total, all-cause mortality | Vehicle Cream BID | 0 | 30 |
| Total, other adverse events | Ruxolitinib Cream 1.5% BID | 10 | 58 |
| Total, other adverse events | Vehicle Cream BID | 6 | 30 |
| Total, serious adverse events | Ruxolitinib Cream 1.5% BID | 0 | 58 |
| Total, serious adverse events | Vehicle Cream BID | 1 | 30 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| DBVC Period: Ruxolitinib Cream 1.5% BID vs DBVC Period: Vehicle Cream BID: Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period | Trial comparisons |
DBVC Period: Ruxolitinib Cream 1.5% BID vs DBVC Period: Vehicle Cream BID: Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Double-blind, Vehicle-controlled Period | Trial comparisons |
DBVC Period: Ruxolitinib Cream 1.5% BID vs DBVC Period: Vehicle Cream BID: Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Double-blind, Vehicle-controlled Period | Trial comparisons |
DBVC Period: Ruxolitinib Cream 1.5% BID vs DBVC Period: Vehicle Cream BID: Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Open-label Extension Period | Trial comparisons |
| DBVC Period: Ruxolitinib Cream 1.5% BID vs DBVC Period: Vehicle Cream BID: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period | Trial comparisons |
DBVC Period: Ruxolitinib Cream 1.5% BID vs DBVC Period: Vehicle Cream BID: Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Open-label Extension Period | Trial comparisons |
| Ruxolitinib Cream 1.5% BID vs Vehicle Cream BID: deaths from any cause | Trial comparisons |
| DBVC Period: Ruxolitinib Cream 1.5% BID vs DBVC Period: Vehicle Cream BID: Number of Participants With Any TEAE During the Open-label Extension Period | Trial comparisons |
| DBVC Period: Ruxolitinib Cream 1.5% BID vs DBVC Period: Vehicle Cream BID: Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period | Trial comparisons |
| Ruxolitinib Cream 1.5% BID vs Vehicle Cream BID: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05593445
GET https://conductscience.org/api/trials/v1/NCT05593445/results?page=2