Trial · NCT05593432
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus
NCT05593432, Phase 2, Completed, Incyte Corporation; results first posted 2024-10-24
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus. Trials, record NCT05593432. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05593432
On this page
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 Cutaneous Lichen Planus
- NCT number
- NCT05593432
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 64 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Cutaneous Lichen Planus
- Interventions
- Ruxolitinib cream, Vehicle cream
- First posted
- 2022-10-25
- Last updated
- 2024-10-24
- Results first posted
- 2024-10-24
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 Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) at Week 16 | Baseline; Week 16 | The Investigator's Global Assessment (IGA) is a modified global assessment tool to assess the severity of lesions. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at Week 16. |
| Secondary | Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period | Baseline; Weeks 2, 4, 8, 12, and 16 | The IGA is a global assessment tool to assess the severity of lesions. The IGA includes items such as depigmentation/hypopigmentation, lichenification (fine wrinkling/cigarette paper skin), excoriations, petechiae/ecchymosis, telangiectasias, erosions, fissures, or ulcers. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at each scheduled post-Baseline visit. Participants with a score of 0 have a morphology of: no inflammatory signs (no erythema, no induration/papulation). Postinflammatory hyperpigmentation and/or hypopigmentation may be present. Participants with a score of 1 have a morphology of: barely perceptible erythema, barely perceptible induration/papulation/elevation, and/or minimal scale. Features include palpable, slightly erythematous papules. |
| Secondary | Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Open-label Extension Period | Baseline; Weeks 18, 20, 24, 28, and 32 | The IGA is a global assessment tool to assess the severity of lesions. The IGA includes items such as depigmentation/hypopigmentation, lichenification (fine wrinkling/cigarette paper skin), excoriations, petechiae/ecchymosis, telangiectasias, erosions, fissures, or ulcers. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at each scheduled post-Baseline visit. Participants with a score of 0 have a morphology of: no inflammatory signs (no erythema, no induration/papulation). Postinflammatory hyperpigmentation and/or hypopigmentation may be present. Participants with a score of 1 have a morphology of: barely perceptible erythema, barely perceptible induration/papulation/elevation, and/or minimal scale. Features include palpable, slightly erythematous papules. |
| Secondary | Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period | Baseline; Weeks 2, 4, 8, 12, and 16 | ITCH4 response was defined as a ≥4-point improvement in the Itch Numeric Rating Scale (NRS) score from Baseline at each scheduled post-Baseline visit, up to and including Week 32. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants were instructed to complete and record their Itch NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated itch severity of their lichen planus 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 | Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Open-label Extension Period | Baseline; Weeks 18, 20, 24, 28, and 32 | ITCH4 response was defined as a ≥4-point improvement in the Itch Numeric Rating Scale (NRS) score from Baseline at each scheduled post-Baseline visit, up to and including Week 32. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants were instructed to complete and record their Itch NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated itch severity of their lichen planus 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 | Time to Achieve ITCH4 in the Double-blind, Vehicle-controlled Period | up to Week 16 | ITCH4 response was defined as a ≥4-point improvement in the Itch Numeric Rating Scale (NRS) score from Baseline at each scheduled post-Baseline visit, up to and including Week 32. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants were instructed to complete and record their Itch NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated itch severity of their lichen planus 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 Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period | Baseline; Weeks 2, 4, 8, 12, and 16 | Participants were instructed to complete and record the Skin Pain NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated their pain, which included all types of pain (e.g., burning, tearing, pulling, stabbing, etc.) severity of lichen planus 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. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Open-label Extension Period | Baseline; Weeks 18, 20, 24, 28, and 32 | Participants were instructed to complete and record the Skin Pain NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated their pain, which included all types of pain (e.g., burning, tearing, pulling, stabbing, etc.) severity of lichen planus 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. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period | from Baseline to Week 16 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 16 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. |
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 Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) at Week 16 | Baseline; Week 16 | 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 during their participation in the Double-blind; vehicle-controlled (DBVC) period. Missing post-Baseline values were imputed as nonresponders. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period | Baseline; Weeks 2, 4, 8, 12, and 16 | ITT Population. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Open-label Extension Period | Baseline; Weeks 18, 20, 24, 28, and 32 | ITT Population. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period | Baseline; Weeks 2, 4, 8, 12, and 16 | ITT Population. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Open-label Extension Period | Baseline; Weeks 18, 20, 24, 28, and 32 | ITT Population. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Time to Achieve ITCH4 in the Double-blind, Vehicle-controlled Period | up to Week 16 | ITT Population. Only those participants achieving a ≥4-point improvement in daily Itch NRS score from Baseline were analyzed. | days | MEDIAN |
| SECONDARY | Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period | Baseline; Weeks 2, 4, 8, 12, and 16 | ITT Population. No imputation was performed for missing values. Only participants with available data were analyzed. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Open-label Extension Period | Baseline; Weeks 18, 20, 24, 28, and 32 | ITT Population. Only participants with available data were analyzed. | scores on a scale | MEAN |
| SECONDARY | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period | from Baseline to Week 16 plus 30 days | Safety Population: all participants who applied ruxolitinib 1.5% cream BID or vehicle cream BID at least once. Treatment groups for this population were determined according to the actual treatment the participant applied on Day 1 regardless of assigned study drug treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period | from Baseline to Week 16 plus 30 days | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) at Week 16 | Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID | 50.0 | 95% Confidence Interval 31.9 to 68.1 | percentage of participants | |
| Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) at Week 16 | Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID | 21.9 | 95% Confidence Interval 9.3 to 40.0 | percentage of participants | |
| Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period | Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID | Week 2 | 9.7 | 95% Confidence Interval 2.0 to 25.8 | percentage of participants |
| Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period | Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID | Week 2 | 6.5 | 95% Confidence Interval 0.8 to 21.4 | percentage of participants |
| Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period | Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID | Week 4 | 25.8 | 95% Confidence Interval 11.9 to 44.6 | percentage of participants |
| Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period | Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID | Week 4 | 13.3 | 95% Confidence Interval 3.8 to 30.7 | percentage of participants |
| Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period | Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID | Week 8 | 51.6 | 95% Confidence Interval 33.1 to 69.8 | percentage of participants |
| Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period | Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID | Week 8 | 12.9 | 95% Confidence Interval 3.6 to 29.8 | percentage of participants |
| Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period | Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID | Week 12 | 53.3 | 95% Confidence Interval 34.3 to 71.7 | percentage of participants |
| Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period | Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID | Week 12 | 24.1 | 95% Confidence Interval 10.3 to 43.5 | percentage of participants |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 16-Week DBVC Period | STARTED | Double-Blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib Cream 1.5% BID | 32 | |
| 16-Week DBVC Period | STARTED | Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID | 32 | |
| 16-Week DBVC Period | STARTED | Open-Label Extension (OLE) Period: Ruxolitinib Cream 1.5% BID | 0 | |
| 16-Week DBVC Period | STARTED | Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID | 0 | |
| 16-Week DBVC Period | COMPLETED | Double-Blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib Cream 1.5% BID | 30 | |
| 16-Week DBVC Period | COMPLETED | Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID | 29 | |
| 16-Week DBVC Period | COMPLETED | Open-Label Extension (OLE) Period: Ruxolitinib Cream 1.5% BID | 0 | |
| 16-Week DBVC Period | COMPLETED | Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID | 0 | |
| 16-Week DBVC Period | NOT COMPLETED | Double-Blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib Cream 1.5% BID | 2 | |
| 16-Week DBVC Period | NOT COMPLETED | Double-Blind, Vehicle-Controlled 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 | Vehicle Cream BID | 1 | 32 | 1 |
| other | COVID-19 | Infections and infestations | Ruxolitinib Cream 1.5% BID | 3 | 60 | 3 |
| other | Hypothyroidism | Endocrine disorders | Vehicle Cream BID | 2 | 32 | 2 |
| other | Hypothyroidism | Endocrine disorders | Ruxolitinib Cream 1.5% BID | 0 | 60 | 0 |
| other | Nasopharyngitis | Infections and infestations | Vehicle Cream BID | 1 | 32 | 1 |
| other | Nasopharyngitis | Infections and infestations | Ruxolitinib Cream 1.5% BID | 5 | 60 | 5 |
| other | Sinusitis | Infections and infestations | Vehicle Cream BID | 1 | 32 | 1 |
| other | Sinusitis | Infections and infestations | Ruxolitinib Cream 1.5% BID | 3 | 60 | 3 |
| other | Upper respiratory tract infection | Infections and infestations | Vehicle Cream BID | 0 | 32 | 0 |
| other | Upper respiratory tract infection | Infections and infestations | Ruxolitinib Cream 1.5% BID | 3 | 60 | 3 |
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 | Vehicle Cream BID | 0 | 32 |
| Total, all-cause mortality | Ruxolitinib Cream 1.5% BID | 0 | 60 |
| Total, other adverse events | Vehicle Cream BID | 6 | 32 |
| Total, other adverse events | Ruxolitinib Cream 1.5% BID | 14 | 60 |
| Total, serious adverse events | Vehicle Cream BID | 0 | 32 |
| Total, serious adverse events | Ruxolitinib Cream 1.5% BID | 0 | 60 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42776548 | DERIVED |
Source PubMed
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID vs Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period | Trial comparisons |
Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID vs Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID: Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period | Trial comparisons |
Open-Label Extension Period: Ruxolitinib Cream 1.5% BID vs Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% 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: deaths from any cause | Trial comparisons |
Open-Label Extension Period: Ruxolitinib Cream 1.5% BID vs Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID: Number of Participants With Any 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/NCT05593432
GET https://conductscience.org/api/trials/v1/NCT05593432/results?page=2