Trial Outcomes & Findings for Ruxolitinib in Seborrheic Dermatitis (NCT NCT05787860)

NCT ID: NCT05787860

Last Updated: 2025-05-06

Results Overview

Number of Participants with Investigator Global Assessment of 0 or 1 at Week 4 IGA Scale from 0-4 Clear 0 No signs of SD Almost Clear 1 Just perceptible erythema and just perceptible scaling Mild 2 Mild erythema and mild scaling Moderate 3 Moderate erythema and moderate scaling Severe 4 Severe erythema and severe scaling

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

At end of Treatment, Week 4

Results posted on

2025-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	Ruxolitinib Cream Participants will receive topical ruxolitinib 1.5% cream Ruxolitinib 1.5% Cream: topical ruxolitinib 1.5% cream twice daily for 4 weeks	Healthy Control Subjects Age- and gender-matched healthy control subjects
Overall Study STARTED	25	20
Overall Study COMPLETED	25	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ruxolitinib in Seborrheic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ruxolitinib Cream n=25 Participants Ruxolitinib 1.5% Cream: topical ruxolitinib 1.5% cream twice daily for 4 weeks	Healthy Control Subjects n=20 Participants Age- and gender-matched healthy control subjects	Total n=45 Participants Total of all reporting groups
Age, Continuous	46 years n=5 Participants	42 years n=7 Participants	45 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	10 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: At end of Treatment, Week 4

Population: Data collected only for participants with SD

Number of Participants with Investigator Global Assessment of 0 or 1 at Week 4 IGA Scale from 0-4 Clear 0 No signs of SD Almost Clear 1 Just perceptible erythema and just perceptible scaling Mild 2 Mild erythema and mild scaling Moderate 3 Moderate erythema and moderate scaling Severe 4 Severe erythema and severe scaling

Outcome measures

Outcome measures
Measure	Ruxolitinib Cream n=25 Participants Ruxolitinib 1.5% Cream: topical ruxolitinib 1.5% cream twice daily for 4 weeks	Healthy Control Subjects Age- and gender-matched healthy control subjects
Number of Participants With Investigator Global Assessment of 0 or 1 at Week 4	20 Participants	—

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: Data collected only for participants with SD

IGA Scale from 0-4 Clear 0 No signs of SD Almost Clear 1 Just perceptible erythema and just perceptible scaling Mild 2 Mild erythema and mild scaling Moderate 3 Moderate erythema and moderate scaling Severe 4 Severe erythema and severe scaling

Outcome measures

Outcome measures
Measure	Ruxolitinib Cream n=25 Participants Ruxolitinib 1.5% Cream: topical ruxolitinib 1.5% cream twice daily for 4 weeks	Healthy Control Subjects Age- and gender-matched healthy control subjects
Change in Investigator Global Assessment From Baseline to Week 4	-2.16 score on a scale Standard Deviation 0.69	—

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 6

Population: Data collected only for participants with SD

Mean Change in seborrheic dermatitis severity score from baseline and week 4, baseline a d week 6 and week 4 and week 6 SD Severity Score (the sum of the three clinical features for a total score ranging from 0-12), where higher scores indicate more severe outcomes. Scale 0-4 Erythema 0-4 Pruritus 0-4 (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)

Outcome measures

Outcome measures
Measure	Ruxolitinib Cream n=25 Participants Ruxolitinib 1.5% Cream: topical ruxolitinib 1.5% cream twice daily for 4 weeks	Healthy Control Subjects Age- and gender-matched healthy control subjects
Mean Change in Seborrheic Dermatitis Severity Score baseline and week 4	-6 mean change in score on a scale Standard Deviation 1.61	—
Mean Change in Seborrheic Dermatitis Severity Score baseline and week 6	-2.8 mean change in score on a scale Standard Deviation 2.96	—
Mean Change in Seborrheic Dermatitis Severity Score week 4 and week 6	3.2 mean change in score on a scale Standard Deviation 2.52	—

SECONDARY outcome

Timeframe: Baseline, Week 4, and Week 6

Population: Data collected only for participants with SD

Mean Change in seborrheic dermatitis severity score for Scale from baseline and week 4, baseline and week 6, week 4 and week 6 Scale 0-4, where higher scores indicate more severe outcomes. (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)

Outcome measures

Outcome measures
Measure	Ruxolitinib Cream n=25 Participants Ruxolitinib 1.5% Cream: topical ruxolitinib 1.5% cream twice daily for 4 weeks	Healthy Control Subjects Age- and gender-matched healthy control subjects
Mean Change in Seborrheic Dermatitis Severity Score for Scale baseline and week 4	-1.56 mean change in score on a scale Standard Deviation 0.87	—
Mean Change in Seborrheic Dermatitis Severity Score for Scale baseline and week 6	-0.56 mean change in score on a scale Standard Deviation 1.29	—
Mean Change in Seborrheic Dermatitis Severity Score for Scale week 4 and week 6	3.2 mean change in score on a scale Standard Deviation 2.52	—

SECONDARY outcome

Timeframe: Baseline, Week 4, and Week 6

Population: Data collected only for participants with SD

Change in seborrheic dermatitis severity score for Erythema from baseline and week 4, baseline and week 6, week 4 and week 6 Erythema 0-4, where higher scores indicate more severe outcomes. (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)

Outcome measures

Outcome measures
Measure	Ruxolitinib Cream n=25 Participants Ruxolitinib 1.5% Cream: topical ruxolitinib 1.5% cream twice daily for 4 weeks	Healthy Control Subjects Age- and gender-matched healthy control subjects
Change in Seborrheic Dermatitis Severity Score for Erythema baseline and week 4	-2 mean change in score on a scale Standard Deviation 0.76	—
Change in Seborrheic Dermatitis Severity Score for Erythema baseline and week 6	-1.04 mean change in score on a scale Standard Deviation 1.06	—
Change in Seborrheic Dermatitis Severity Score for Erythema week 4 and week 6	0.96 mean change in score on a scale Standard Deviation 0.98	—

SECONDARY outcome

Timeframe: Baseline Week 4, and Week 6

Population: Data collected only for participants with SD

Change in seborrheic dermatitis severity score for Pruritus from baseline and week 4, baseline and week 6, week 4 and week 6 Pruritus 0-4, where higher scores indicate more severe outcomes. (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)

Outcome measures

Outcome measures
Measure	Ruxolitinib Cream n=25 Participants Ruxolitinib 1.5% Cream: topical ruxolitinib 1.5% cream twice daily for 4 weeks	Healthy Control Subjects Age- and gender-matched healthy control subjects
Change in Seborrheic Dermatitis Severity Score for Pruritus baseline and week 4	-2.44 mean change in score on a scale Standard Deviation 0.71	—
Change in Seborrheic Dermatitis Severity Score for Pruritus baseline and week 6	-1.2 mean change in score on a scale Standard Deviation 1.12	—
Change in Seborrheic Dermatitis Severity Score for Pruritus week 4 and week 6	1.24 mean change in score on a scale Standard Deviation 0.97	—

SECONDARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	Ruxolitinib Cream n=25 Participants Ruxolitinib 1.5% Cream: topical ruxolitinib 1.5% cream twice daily for 4 weeks	Healthy Control Subjects n=20 Participants Age- and gender-matched healthy control subjects
Frequency of Adverse Events	0 events	0 events

SECONDARY outcome

Timeframe: 6 weeks

Population: As there were no adverse events, duration could not be calculated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: As there were no adverse events, severity of adverse events could not be calculated.

Severity will be measured as a category (mild, moderate, or severe).

Outcome measures

Outcome data not reported

Adverse Events

Ruxolitinib Cream

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Control Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Giselle Singer

Icahn School of Medicine at Mount Sinai

Phone: 212-241-3288

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place