Trial · NCT02553330

A Study With Ruxolitinib Phosphate Cream Applied Topically to Subjects With Alopecia Areata (AA)

NCT02553330, Phase 2, Terminated, Incyte Corporation; results first posted 2020-12-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study With Ruxolitinib Phosphate Cream Applied Topically to Subjects With Alopecia Areata (AA). Trials, record NCT02553330. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02553330

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Trial

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

Title: A Study With Ruxolitinib Phosphate Cream Applied Topically to Subjects With Alopecia Areata (AA)
NCT number: NCT02553330
Status: Terminated
Phases: Phase 2
Enrollment: 90 participants, actual
Lead sponsor: Incyte Corporation
Conditions: Alopecia Areata
Interventions: Placebo Cream, Ruxolitinib Phosphate Cream
First posted: 2015-09-17
Last updated: 2020-12-16
Results first posted: 2020-12-16

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	Part A: Percentage of Participants Achieving a ≥ 50% Improvement in SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).	Up to Week 24	Percentage of subjects achieving a SALT 50 (defined as a ≥ 50% improvement from baseline in SALT). SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss.
Primary	Part B : Percentage of Participants Achieving a SALT50 Response in Terminal Hair (Pigmented and Nonpigmented)	Week 24	Percentage of subjects achieving a SALT 50 (defined as a ≥ 50% improvement from baseline in SALT). SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss.
Secondary	Part A : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair.	Up to Week 24	Number of participants achieving 50% or greater improvement in their SALT score (SALT50) compared to Baseline. SALT score 0-100 with lower score indicating better health outcomes.
Secondary	Part B : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).	Week 24	Number of participants achieving 50% or greater improvement in their SALT score (SALT50) compared to Baseline. SALT score 0-100 with lower score indicating better health outcomes.
Secondary	Part A and B : Percentage of Participants Achieving a SALT90 Response in Terminal Hair.	Weeks 4, 8, 12, 18, and 24.	Number of participants achieving 90% or greater improvement in their SALT score (SALT90) compared to Baseline. SALT score 0-100 with lower score indicating better health outcomes.
Secondary	Part B : Percentage of Subjects Whose AA Lesions Treated Since Baseline Achieved a Physician's Global Assessment of Regrowth (PGARG) Score of at Least 3	Baseline to Week 24	Number of subjects achieving a Physician's Global Assessment (PGA) score of 3 or above at week 24 (0, no regrowth; 1, \<25% of regrowth; 2, 25%-49% of regrowth; 3, 50%-74% of regrowth; 4, 75%-99% of re- growth; 5, 100% of regrowth).
Secondary	Part B : Percentage of Participants Achieving a SALT50 in Terminal Hair (Pigmented and Nonpigmented).	Weeks 4, 8, 12, and 18.	Number of participants achieving 50% or greater improvement in their SALT score (SALT50) compared to Baseline. SALT score 0-100 with lower score indicating better health outcomes
Secondary	Part B: Mean Change From Baseline in SALT Score	Weeks 4, 8, 12, 18, and 24.	Severity of Alopecia Tool Score (SALT) calculation is based on a scoring system. The scalp is divided into the following 4 areas: 1) Vertex: 40% (0.4) of scalp surface area, 2) Right profile of scalp: 18% (0.18) of scalp surface area, 3) Left profile of scalp: 18% (0.18) of scalp surface area, and 4) Posterior aspect of scalp: 24% (0.24) of scalp surface area. The percentage of hair loss in any of these areas is the percentage hair loss multiplied by percent surface area of the scalp in that area. The SALT score is the sum of percentage of hair loss in all the above-mentioned areas, so a lower number indicates a better outcome. The reported SALT score range is from a minimum of 0 (no hair loss) to a maximum of 100 (100% hair loss).
Secondary	Part A and B : Number of Treatment-emergent Adverse Events	Up to 100 weeks	Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Part A: Percentage of Participants Achieving a ≥ 50% Improvement in SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).	Up to Week 24	Part A evaluable population in treatment period includes all subjects exposed to at least 1 dose of study drug in that period.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Part B : Percentage of Participants Achieving a SALT50 Response in Terminal Hair (Pigmented and Nonpigmented)	Week 24	Intent to Treat population in the Part B treatment period i.e all participants who are randomized	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Part A : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair.	Up to Week 24	The subgroup analysis was performed on subjects exposed to at least 1 dose of study drug in that period with a baseline SALT score of 50-100%.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Part B : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).	Week 24	The subgroup analysis was performed on subjects exposed to at least 1 dose of study drug in that period with a baseline SALT score of 50-100%.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Part A and B : Percentage of Participants Achieving a SALT90 Response in Terminal Hair.	Weeks 4, 8, 12, 18, and 24.	Part A evaluable population in treatment period includes all subjects exposed to at least 1 dose of study drug in that period.~Intent to Treat population in the Part B treatment period i.e all participants who are randomized.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Part B : Percentage of Subjects Whose AA Lesions Treated Since Baseline Achieved a Physician's Global Assessment of Regrowth (PGARG) Score of at Least 3	Baseline to Week 24	Intent to Treat population in the Part B treatment period i.e all participants who are randomized. Participants dropped out of study by week 24 were excluded from analysis.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Part B : Percentage of Participants Achieving a SALT50 in Terminal Hair (Pigmented and Nonpigmented).	Weeks 4, 8, 12, and 18.	Intent to Treat population in the Part B treatment period i.e all participants who are randomized.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Part B: Mean Change From Baseline in SALT Score	Weeks 4, 8, 12, 18, and 24.	Intent to Treat population in the Part B treatment period i.e all participants who are randomized.	Units on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Part A and B : Number of Treatment-emergent Adverse Events	Up to 100 weeks	All enrolled subjects who received at least 1 dose of INCB018424 or Placebo.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group55

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

Outcome	Group	Category	Value	Units
Part A: Percentage of Participants Achieving a ≥ 50% Improvement in SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).	Part A: Ruxolitinib Cream	Week 4	0	Participants
Part A: Percentage of Participants Achieving a ≥ 50% Improvement in SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).	Part A: Ruxolitinib Cream	Week 8	0	Participants
Part A: Percentage of Participants Achieving a ≥ 50% Improvement in SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).	Part A: Ruxolitinib Cream	Week 12	3	Participants
Part A: Percentage of Participants Achieving a ≥ 50% Improvement in SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).	Part A: Ruxolitinib Cream	Week 18	4	Participants
Part A: Percentage of Participants Achieving a ≥ 50% Improvement in SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).	Part A: Ruxolitinib Cream	Week 24	6	Participants
Part B : Percentage of Participants Achieving a SALT50 Response in Terminal Hair (Pigmented and Nonpigmented)	Part B : Placebo Cream		5	Participants
Part B : Percentage of Participants Achieving a SALT50 Response in Terminal Hair (Pigmented and Nonpigmented)	Part B: Ruxolitinib Cream		5	Participants
Part A : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair.	Part A: Ruxolitinib Cream	Week 4	0	Participants
Part A : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair.	Part A: Ruxolitinib Cream	Week 8	0	Participants
Part A : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair.	Part A: Ruxolitinib Cream	Week 12	2	Participants

1 to 10 of 55Source ClinicalTrials.gov

See all 55 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Part A: Ruxolitinib Cream	12
Overall Study	STARTED	Part B : Placebo Cream	39
Overall Study	STARTED	Part B : Ruxolitinib Cream	39
Overall Study	COMPLETED	Part A: Ruxolitinib Cream	7
Overall Study	COMPLETED	Part B : Placebo Cream	0
Overall Study	COMPLETED	Part B : Ruxolitinib Cream	2
Overall Study	NOT COMPLETED	Part A: Ruxolitinib Cream	5
Overall Study	NOT COMPLETED	Part B : Placebo Cream	39
Overall Study	NOT COMPLETED	Part B : Ruxolitinib Cream	37

Source ClinicalTrials.gov

Adverse events24

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	Bronchitis	Infections and infestations	Placebo Cream	2	38	2
other	Bronchitis	Infections and infestations	Ruxolitinib Cream	2	83	2
other	Nasopharyngitis	Infections and infestations	Placebo Cream	6	38	6
other	Nasopharyngitis	Infections and infestations	Ruxolitinib Cream	13	83	16
other	Pruritus	Skin and subcutaneous tissue disorders	Placebo Cream	3	38	3
other	Pruritus	Skin and subcutaneous tissue disorders	Ruxolitinib Cream	10	83	11
other	Sinusitis	Infections and infestations	Placebo Cream	1	38	1
other	Sinusitis	Infections and infestations	Ruxolitinib Cream	7	83	7
other	Skin exfoliation	Skin and subcutaneous tissue disorders	Placebo Cream	3	38	3
other	Skin exfoliation	Skin and subcutaneous tissue disorders	Ruxolitinib Cream	3	83	3

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo Cream	0	38
Total, all-cause mortality	Ruxolitinib Cream	0	83
Total, other adverse events	Placebo Cream	14	38
Total, other adverse events	Ruxolitinib Cream	31	83
Total, serious adverse events	Placebo Cream	0	38
Total, serious adverse events	Ruxolitinib Cream	4	83

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28619556	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 comparisons5

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

Comparison	Source
Part B: Ruxolitinib Cream vs Part B : Placebo Cream: Part B : Percentage of Participants Achieving a SALT50 Response in Terminal Hair (Pigmented and Nonpigmented)	Trial comparisons
Part B : Ruxolitinib Cream vs Part B : Placebo Cream: Part B : Percentage of Subjects Whose AA Lesions Treated Since Baseline Achieved a Physician's Global Assessment of Regrowth (PGARG) Score of at Least 3	Trial comparisons
Ruxolitinib Cream vs Placebo Cream: deaths from any cause	Trial comparisons
Part B : Ruxolitinib Cream vs Part B : Placebo Cream: Part B : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).	Trial comparisons
Ruxolitinib Cream vs Placebo Cream: 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.

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/NCT02553330

GET https://conductscience.org/api/trials/v1/NCT02553330/results?page=2

API reference For AI assistants