Trial · NCT03697460

Topical Ruxolitinib Lichen Planus

NCT03697460, Phase 2, Completed, Aaron R. Mangold; results first posted 2021-08-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Topical Ruxolitinib Lichen Planus. Trials, record NCT03697460. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03697460

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Topical Ruxolitinib Lichen Planus
NCT number: NCT03697460
Status: Completed
Phases: Phase 2
Enrollment: 12 participants, actual
Lead sponsor: Aaron R. Mangold
Conditions: Lichen Planus
Interventions: INCB018424
First posted: 2018-10-05
Last updated: 2021-08-04
Results first posted: 2021-08-04
Limitations and caveats: All subjects reached the 4 week endpoint. Due to surrounding the Covid-19 pandemic, 2 subjects did not complete weeks 8 or 12 and 1 subject did not complete week 12.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Modified Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (mCAILS)	week 0, week 4	mCAILS summation score as measured by Erythema (0-8), Scaling (0-8) Plaque elevation (0-8) Hyper/hypopigmentation (0-8) Size (0-18), Total score ranging from 0-50 with higher score indicating higher severity
Primary	Change in Total Body Lesion Count	week 0, week 4	The number of total body lesions.
Secondary	Change in Pruritus Numerical Rating Scale	week 0, week 4	Pruritus Numerical Rating Scale as measured by they question "How severe has your itching been over the last 24 hours?" Ranging from 0 = none, to 10 = severe. The higher the score the more severe.
Secondary	Change in Overall Quality of Life Skindex-16 Score	week 0, week 4	Skindex-16 score as measured by 16 questions, 3 subscales: Symptoms, Emotional, Functional. Score ranges for each question (0-6). Total score ranging from 0-96 with higher score indicating worse quality of life
Secondary	Number of Subjects With Greater Than or Equal to 50% Improvement in Physician Global Assessment Score	week 0, week 4	PGA score as measured by Grade 0 (clear: no evidence of disease (100% improvement)) to Grade 6 (Worse, disease is worse than at baseline evaluation by (≥25%) or more). Higher score equals worse disease
Secondary	Body Surface Area (BSA) Affected by Cutaneous Lichen Planus	week 0, week 4	BSA as measured as the percentage of the body affected by Cutaneous Lichen Planus. Ranging from 0-100% of the body.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change in Modified Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (mCAILS)	week 0, week 4	score on a scale	MEAN
PRIMARY	Change in Total Body Lesion Count	week 0, week 4	lesions	MEDIAN
SECONDARY	Change in Pruritus Numerical Rating Scale	week 0, week 4	score on a scale	MEAN
SECONDARY	Change in Overall Quality of Life Skindex-16 Score	week 0, week 4	score on a scale	MEAN
SECONDARY	Number of Subjects With Greater Than or Equal to 50% Improvement in Physician Global Assessment Score	week 0, week 4	participants	NUMBER
SECONDARY	Body Surface Area (BSA) Affected by Cutaneous Lichen Planus	week 0, week 4	mean percentage of body surface area	MEAN

Source ClinicalTrials.gov

Results by group7

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Modified Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (mCAILS)	INCB018424		11.0	Standard Deviation 6.2	score on a scale
Change in Total Body Lesion Count	INCB018424		50	Inter-Quartile Range 25 to 723	lesions
Change in Pruritus Numerical Rating Scale	INCB018424		4.4	Standard Deviation 3.0	score on a scale
Change in Overall Quality of Life Skindex-16 Score	INCB018424		36.3	Standard Deviation 17.5	score on a scale
Number of Subjects With Greater Than or Equal to 50% Improvement in Physician Global Assessment Score	INCB018424		12		participants
Body Surface Area (BSA) Affected by Cutaneous Lichen Planus	INCB018424	Week 0	6.1	Standard Deviation 7.9	mean percentage of body surface area
Body Surface Area (BSA) Affected by Cutaneous Lichen Planus	INCB018424	Week 4	0.9	Standard Deviation 1.9	mean percentage of body surface area

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	INCB018424	12
Overall Study	COMPLETED	INCB018424	9
Overall Study	NOT COMPLETED	INCB018424	3

Source ClinicalTrials.gov

Adverse events13

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	Abnormal Taste	Nervous system disorders	INCB018424	1	12	1
other	Blood Clot	Blood and lymphatic system disorders	INCB018424	1	12	1
other	Cold	General disorders	INCB018424	1	12	1
other	Dizziness	Nervous system disorders	INCB018424	2	12	2
other	Fever	General disorders	INCB018424	1	12	1
other	Incontinence	Renal and urinary disorders	INCB018424	1	12	1
other	Light headedness	Nervous system disorders	INCB018424	1	12	1
other	Sleep Disturbance	Psychiatric disorders	INCB018424	1	12	1
other	Pressure on right arm	Musculoskeletal and connective tissue disorders	INCB018424	1	12	1
other	Sinus Infection	Infections and infestations	INCB018424	1	12	1

1 to 10 of 13Source ClinicalTrials.gov

See all 13 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	INCB018424	0	12
Total, other adverse events	INCB018424	7	12
Total, serious adverse events	INCB018424	0	12

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35131254	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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03697460

GET https://conductscience.org/api/trials/v1/NCT03697460/registered

API reference For AI assistants