Trial · NCT05247489

A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream With Phototherapy in Participants With Vitiligo

NCT05247489, Phase 2, Completed, Incyte Corporation; results first posted 2025-02-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream With Phototherapy in Participants With Vitiligo. Trials, record NCT05247489. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05247489

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Trial

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

Title: A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream With Phototherapy in Participants With Vitiligo
NCT number: NCT05247489
Status: Completed
Phases: Phase 2
Enrollment: 55 participants, actual
Lead sponsor: Incyte Corporation
Conditions: Vitiligo
Interventions: Ruxolitinib 1.5% cream, NB-UVB phototherapy
First posted: 2022-02-21
Last updated: 2025-02-20
Results first posted: 2025-02-20

Source ClinicalTrials.gov

Registered outcomes17

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 48	Baseline; Week 48	T-VASI was calculated with contributions from 6 body sites. The percentage of vitiligo involvement was estimated in hand units (percentage of body surface area \[BSA\] estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each body site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values (range: 0-100; lower scores indicate increased improvement).
Secondary	Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	up to approximately 52 weeks	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 cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.
Secondary	Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Each Post-Baseline Visit	Baseline; up to Week 48	An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).
Secondary	Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Each Post-Baseline Visit	Baseline; up to Week 48	An F-VASI75 responder achieved at least 75% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).
Secondary	Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Each Post-Baseline Visit	Baseline; up to Week 48	An F-VASI90 responder achieved at least 90% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).
Secondary	Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Each Post-Baseline Visit	Baseline; up to Week 48	A T-VASI50 responder achieved ≥50% improvement from Baseline in T-VASI, calculated with contributions from 6 body sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to the nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each body site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values (range: 0-100; lower scores indicate increased improvement).
Secondary	Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) Score at Each Post-Baseline Visit	Baseline; up to Week 48	A T-VASI75 responder achieved ≥75% improvement from Baseline in T-VASI, calculated with contributions from 6 body sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to the nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each body site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values (range: 0-100; lower scores indicate increased improvement).
Secondary	Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI90) Score at Each Post-Baseline Visit	Baseline; up to Week 48	A T-VASI90 responder achieved ≥90% improvement from Baseline in T-VASI, calculated with contributions from 6 body sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to the nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each body site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values (range: 0-100; lower scores indicate increased improvement).
Secondary	Change From Baseline in F-VASI at Each Post-Baseline Visit	Baseline; up to Week 48	F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Secondary	Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit	Baseline; up to Week 48	F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Percentage change = (\[post-Baseline (BL) value minus BL value\]/BL value) X 100.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 48	Baseline; Week 48	Full Analysis Set: all participants enrolled in the study who applied study cream at least once. Only participants with available data were analyzed. Change from Baseline was calculated as the Week 48 value minus the Baseline value.	scores on a scale	MEAN
SECONDARY	Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	up to approximately 52 weeks	Full Analysis Set	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Each Post-Baseline Visit	Baseline; up to Week 48	Full Analysis Set. Only participants with available data were analyzed.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Each Post-Baseline Visit	Baseline; up to Week 48	Full Analysis Set. Only participants with available data were analyzed.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Each Post-Baseline Visit	Baseline; up to Week 48	Full Analysis Set. Only participants with available data were analyzed.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Each Post-Baseline Visit	Baseline; up to Week 48	Full Analysis Set. Only participants with available data were analyzed.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) Score at Each Post-Baseline Visit	Baseline; up to Week 48	Full Analysis Set. Only participants with available data were analyzed.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI90) Score at Each Post-Baseline Visit	Baseline; up to Week 48	Full Analysis Set. Only participants with available data were analyzed.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in F-VASI at Each Post-Baseline Visit	Baseline; up to Week 48	Full Analysis Set. Only participants with available data were analyzed.	scores on a scale	MEAN
SECONDARY	Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit	Baseline; up to Week 48	Full Analysis Set. Only participants with available data were analyzed.	percent change	MEAN

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group244

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 48	Ruxolitinib 1.5% Cream BID	Baseline	6.58	Standard Deviation 2.163	scores on a scale
Change From Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 48	Ruxolitinib 1.5% Cream BID + NB-UVB	Baseline	6.87	Standard Deviation 2.103	scores on a scale
Change From Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 48	Ruxolitinib 1.5% Cream BID	Change from Baseline at Week 48	-3.43	Standard Deviation 1.219	scores on a scale
Change From Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 48	Ruxolitinib 1.5% Cream BID + NB-UVB	Change from Baseline at Week 48	-3.46	Standard Deviation 2.106	scores on a scale
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	Ruxolitinib 1.5% Cream BID		9		Participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	Ruxolitinib 1.5% Cream BID + NB-UVB		21		Participants
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Each Post-Baseline Visit	Ruxolitinib 1.5% Cream BID	Week 4	6.3	95% Confidence Interval 0.2 to 30.2	percentage of participants
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Each Post-Baseline Visit	Ruxolitinib 1.5% Cream BID + NB-UVB	Week 4	5.7	95% Confidence Interval 0.7 to 19.2	percentage of participants
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Each Post-Baseline Visit	Ruxolitinib 1.5% Cream BID	Week 8	21.4	95% Confidence Interval 4.7 to 50.8	percentage of participants
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Each Post-Baseline Visit	Ruxolitinib 1.5% Cream BID + NB-UVB	Week 8	17.1	95% Confidence Interval 6.6 to 33.6	percentage of participants

1 to 10 of 244Source ClinicalTrials.gov

See all 244 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ruxolitinib 1.5% Cream BID	20
Overall Study	STARTED	Ruxolitinib 1.5% Cream BID + NB-UVB	35
Overall Study	COMPLETED	Ruxolitinib 1.5% Cream BID	6
Overall Study	COMPLETED	Ruxolitinib 1.5% Cream BID + NB-UVB	26
Overall Study	NOT COMPLETED	Ruxolitinib 1.5% Cream BID	14
Overall Study	NOT COMPLETED	Ruxolitinib 1.5% Cream BID + NB-UVB	9

Source ClinicalTrials.gov

Adverse events90

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	Acne	Skin and subcutaneous tissue disorders	Ruxolitinib 1.5% Cream BID	1	20	1
other	Acne	Skin and subcutaneous tissue disorders	Ruxolitinib 1.5% Cream BID + NB-UVB	1	35	1
other	Acne	Skin and subcutaneous tissue disorders	Total	2	55	2
other	Animal bite	Injury, poisoning and procedural complications	Ruxolitinib 1.5% Cream BID	1	20	1
other	Animal bite	Injury, poisoning and procedural complications	Ruxolitinib 1.5% Cream BID + NB-UVB	0	35	0
other	Animal bite	Injury, poisoning and procedural complications	Total	1	55	1
other	Application site acne	General disorders	Ruxolitinib 1.5% Cream BID	2	20	2
other	Application site acne	General disorders	Ruxolitinib 1.5% Cream BID + NB-UVB	4	35	4
other	Application site acne	General disorders	Total	6	55	6
other	Bacterial vaginosis	Infections and infestations	Ruxolitinib 1.5% Cream BID	1	20	1

1 to 10 of 90Source ClinicalTrials.gov

See all 90 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ruxolitinib 1.5% Cream BID	0	20
Total, all-cause mortality	Ruxolitinib 1.5% Cream BID + NB-UVB	0	35
Total, all-cause mortality	Total	0	55
Total, other adverse events	Ruxolitinib 1.5% Cream BID	9	20
Total, other adverse events	Ruxolitinib 1.5% Cream BID + NB-UVB	15	35
Total, other adverse events	Total	24	55
Total, serious adverse events	Ruxolitinib 1.5% Cream BID	2	20
Total, serious adverse events	Ruxolitinib 1.5% Cream BID + NB-UVB	0	35
Total, serious adverse events	Total	2	55

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 comparisons1

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

Comparison
Ruxolitinib 1.5% Cream BID vs Ruxolitinib 1.5% Cream BID + NB-UVB: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

Source 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.

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.

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