A Study of Ruxolitinib Phosphate Cream When Applied to Pa... | NCT00820950

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort A: INCB018424 Ruxolitinib 0.5%	Experimental	INCB018424 Ruxolitinib 0.5% vs vehicle applied once daily for 28 days	Drug: Ruxolitinib phosphate cream Drug: Placebo cream
Cohort B: INCB018424 Ruxolitinib 1.0%	Experimental	INCB018424 Ruxolitinib 1.0% vs vehicle applied once daily for 28 days	Drug: Placebo cream Drug: Ruxolitinib phosphate cream
Cohort C: INCB018424 Ruxolitinib 1.5%	Experimental	INCB018424 Ruxolitinib 1.5% vs vehicle applied twice for 28 days	Drug: Placebo cream Drug: Ruxolitinib phosphate cream
Cohort D: 18424 Ruxolitinib vs Dovonex® calcipotriene	Experimental	INCB018424 up to 1.5% versus Dovonex® calcipotriene 0.005% cream applied BID for 28 days	Drug: Dovonex® calcipotriene 0.005%
Cohort E: 18424 Ruxolitinib vs Diprolene® AF betamethasone diproprionate	Experimental	INCB018424 up to 1.5% versus Diprolene ® AF betamethasone dipropionate 0.05% cream applied twice a day for 28 days

Name	Type	Description	Arm Group Labels	Other Names
Ruxolitinib phosphate cream	Drug	Ruxolitinib phosphate cream 0.5%	Cohort A: INCB018424 Ruxolitinib 0.5%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline	The investigator assessed the severity of the clinical signs erythema, scaling, and thickness for each test site by using a 5-point scale from 0 (no evidence) to 4.0 (severe).	Baseline, Days 8, 15, 22, 28 and 56
Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline	The total target lesion score was calculated by summing the scores for erythema, scaling, and thickness for that particular target lesion. The investigator assessed the severity of the clinical signs erythema, scaling, and thickness for each test site by using a 5-point scale from 0 (no evidence) to 4.0 (severe).	Baseline, Days 8, 15, 22, 28 and 56
Number of Participants With Treatment Emergent Adverse Events	A TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug.	3 months
Pharmacokinetics Parameter : Skin Flux of INCB018424	The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each participant.	Days 8, 15, 22, and 28
Pharmacokinetics Parameter : Bioavailability of INCB018424	The INCB018424 bioavailability will be estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study. Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect.	Days 8, 15, 22, and 28

Secondary Outcomes

Measure	Description	Time Frame
Change in Target Lesion Area Compared to Baseline	Lesion area was estimated on Day 1 and Day 28 using a tracings of the lesion on transparency paper and measurement of the area.	Day 28

Eligibility Module

Name	Affiliation	Role
William Williams, MD	Incyte Corporation	Study Director

PubMed Identifier	Type	Citation	Retractions
22281165	Derived	Punwani N, Scherle P, Flores R, Shi J, Liang J, Yeleswaram S, Levy R, Williams W, Gottlieb A. Preliminary clinical activity of a topical JAK1/2 inhibitor in the treatment of psoriasis. J Am Acad Dermatol. 2012 Oct;67(4):658-64. doi: 10.1016/j.jaad.2011.12.018. Epub 2012 Jan 24.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Part 1 Cohort A: Vehicle Cream	Vehicle cream was applied once a day for 28 days
FG001	Part 1 Cohort A Ruxolitinib 0.5% Cream	Ruxolitinib 0.5% was applied once a day for 28 days

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream	Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days
BG001	Part 1 Cohort B: Ruxolitinib 1.0% Cream vs. Vehicle Cream	Ruxolitinib 1.0% cream vs. vehicle cream once a day for 28 days
BG002	Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream	Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days
BG003	Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®)	Ruxolitinib up to 1.5% versus Calcipotriene (Dovonex®) 0.005% cream applied twice a day for 28 days
BG004	Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF)	Part 2 INCB018424, up to 1.5% cream versus Betamethasone Dipropionate (Diprolene® AF) 0.05% cream applied twice a day for 28 days
BG005	Total	Total of all reporting groups

Units	Counts
Participants	BG0006 BG0016 BG0026 BG0036 BG0045 BG00529

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline

The investigator assessed the severity of the clinical signs erythema, scaling, and thickness for each test site by using a 5-point scale from 0 (no evidence) to 4.0 (severe).

Intent-to-Treat (ITT) population; 1 subject in Cohort A discontinued due to a protocol violation (Day 28 visit was late, because subject was on vacation) and 1 subject in Cohort D discontinued due to other reason (scheduling conflicts).

Posted

Mean

Standard Deviation

Scores on a scale

Baseline, Days 8, 15, 22, 28 and 56

ID	Title	Description
OG000	Part 1 Cohort A: Vehicle Cream	Vehicle cream was applied once a day for 28 days
OG001	Part 1 Cohort A: Ruxolitinib 0.5% Cream	Ruxolitinib 0.5% once a day for 28 days
OG002	Part 1 Cohort B: Vehicle Cream	Vehicle cream was applied once a day for 28 days
OG003	Part 1 Cohort B: Ruxolitinib 1.0% Cream	Ruxolitinib 1.0% cream once a day for 28 days
OG004	Part 1 Cohort C: Vehicle Cream	Vehicle cream was applied twice a day for 28 days
OG005	Part 1 Cohort C: Ruxolitinib 1.5% Cream	Ruxolitinib 1.5% twice a day for 28 days
OG006	Part 2 Cohort D: INCB18424	up to 1.5% Ruxolitinib cream was applied twice a day
OG007	Part 2 Cohort D: Calcipotriene (Dovonex®)	Calcipotriene (Dovonex®) 0.005% cream was applied twice a day
OG008	Part 2 Cohort E: INCB18424	up to 1.5% Ruxolitinib cream was applied twice a day
OG009	Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF)	Betamethasone Dipropionate (Diprolene® AF) 0.05% cream was applied twice a day for 28 days

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title	Denominators	Categories
Day 8 - Erythema	ParticipantsOG0006 ParticipantsOG0016 ParticipantsOG0026 ParticipantsOG003

Primary

Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline

The total target lesion score was calculated by summing the scores for erythema, scaling, and thickness for that particular target lesion. The investigator assessed the severity of the clinical signs erythema, scaling, and thickness for each test site by using a 5-point scale from 0 (no evidence) to 4.0 (severe).

ITT population; 1 subject in Cohort A discontinued due to a protocol violation (Day 28 visit was late, because subject was on vacation) and 1 subject in Cohort D discontinued due to other reason (scheduling conflicts)

Posted

Mean

Standard Deviation

Score on Scale

Baseline, Days 8, 15, 22, 28 and 56

ID	Title	Description
OG000	Part 1 Cohort A: Vehicle	placebo cream
OG001	Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream	Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days
OG002	Part 1 Cohort B: Vehicle	Placebo cream
OG003	Part 1 Cohort B: Ruxolitinib 1.0% Cream vs. Vehicle Cream

Primary

Number of Participants With Treatment Emergent Adverse Events

A TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug.

Posted

Count of Participants

Participants

3 months

ID	Title	Description
OG000	Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream	Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days
OG001	Cohort B: Ruxolitinib 1.0% Cream Versus Vehicle	Ruxolitinib 1.0% vs. placebo cream once a day for 28 days
OG002	Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream	Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days
OG003	Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®)	Ruxolitinib up to 1.5% versus Calcipotriene (Dovonex®) 0.005% cream applied twice a day for 28 days
OG004	Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF)

Primary

Pharmacokinetics Parameter : Skin Flux of INCB018424

The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each participant.

Posted

Mean

Standard Deviation

ng/cm^2/h

Days 8, 15, 22, and 28

ID	Title	Description
OG000	Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream	Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days
OG001	Part 1 Cohort B: Ruxolitinib 1.0% Cream Versus Vehicle	Ruxolitinib 1.0% vs. placebo cream once a day for 28 days
OG002	Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream	Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days
OG003	Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®)	Ruxolitinib up to 1.5% versus Calcipotriene (Dovonex®) 0.005% cream applied twice a day for 28 days
OG004	Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF)

Primary

Pharmacokinetics Parameter : Bioavailability of INCB018424

The INCB018424 bioavailability will be estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study. Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect.

Posted

Mean

Standard Deviation

Percentage of dosage

Days 8, 15, 22, and 28

ID	Title	Description
OG000	Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream	Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days
OG001	Cohort B: Ruxolitinib 1.0% Cream Versus Vehicle	Ruxolitinib 1.0% vs. placebo cream once a day for 28 days
OG002	Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream	Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days
OG003	Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®)	Ruxolitinib up to 1.5% versus Calcipotriene (Dovonex®) 0.005% cream applied twice a day for 28 days

Secondary

Change in Target Lesion Area Compared to Baseline

Lesion area was estimated on Day 1 and Day 28 using a tracings of the lesion on transparency paper and measurement of the area.

Posted

Mean

Standard Deviation

cm^2

Day 28

ID	Title	Description
OG000	Cohort A: Vehicle	Placebo cream
OG001	Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream	Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days
OG002	Cohort B: Vehicle	Placebo cream
OG003	Cohort B: Ruxolitinib 1.0% Cream Versus Vehicle	Ruxolitinib 1.0% vs. placebo cream once a day for 28 days
OG004	Cohort C: Vehicle	Placebo cream
OG005

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream	Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days	6	6	6	6
EG001	Part 1 Cohort B: Ruxolitinib 1.0% Cream vs. Vehicle Cream	Ruxolitinib 1.0% cream once a day for 28 days	6	6	1	6
EG002	Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream	Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days	6	6	5	6
EG003	Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®)	Ruxolitinib up to 1.5% versus Calcipotriene (Dovonex®) 0.005% cream applied twice a day for 28 days	6	6	4	6
EG004	Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF)	Part 2 INCB018424, up to 1.5% cream versus Betamethasone Dipropionate (Diprolene® AF) 0.05% cream applied twice a day for 28 days	5	5	2	5
EG005	Total	Total	29	29	18	29

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
APPLICATION SITE REACTION	General disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG0030 events0 affected6 at risk EG0040 events0 affected5 at risk EG0051 events1 affected29 at risk
ATRIOVENTRICULAR BLOCK	Cardiac disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
BLOOD CREATINE PHOSPHOKINASE INCREASED	Investigations	MedDRA 9	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
BLOOD GLUCOSE INCREASED	Investigations	MedDRA 9	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
CONTUSION	Injury, poisoning and procedural complications	MedDRA 9	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0021 events1 affected6 at risk EG003
ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED	Investigations	MedDRA 9	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ELECTROCARDIOGRAM QT INTERVAL ABNORMAL	Investigations	MedDRA 9	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ELECTROCARDIOGRAM QT PROLONGED	Investigations	MedDRA 9	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ELECTROCARDIOGRAM T WAVE ABNORMAL	Investigations	MedDRA 9	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
FEELING COLD	General disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED	Investigations	MedDRA 9	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HAEMATOCRIT DECREASED	Investigations	MedDRA 9	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HAEMOGLOBIN DECREASED	Investigations	MedDRA 9	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
HEADACHE	Nervous system disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA 9	Systematic Assessment	EG0002 events2 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PAIN	General disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PROCEDURAL PAIN	Injury, poisoning and procedural complications	MedDRA 9	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected6 at risk EG0011 events1 affected6 at risk EG0021 events1 affected6 at risk EG003
RASH PRURITIC	Skin and subcutaneous tissue disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
RETICULOCYTE COUNT INCREASED	Investigations	MedDRA 9	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
SINUS BRADYCARDIA	Cardiac disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
SKIN EXFOLIATION	Skin and subcutaneous tissue disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
SKIN IRRITATION	Skin and subcutaneous tissue disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
SUNBURN	Injury, poisoning and procedural complications	MedDRA 9	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 9	Systematic Assessment	EG0002 events2 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
URINE KETONE BODY PRESENT	Investigations	MedDRA 9	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Vallejo	California		United States

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases