Desoximetasone Spray 0.05%, 0.25%; Dose Ranging Study | NCT01018134

ID	Type	Description	Link
70915004	Other Identifier	Novum PRS

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Desoximetasone 0.05% once daily	Experimental	Desoximetasone topical spray 0.05% administered once daily to affected area	Drug: Desoximetasone 0.05% once daily
Desoximetasone 0.05% twice daily	Experimental	Desoximetasone topical spray 0.05% administered twice daily to affected area	Drug: Desoximetasone 0.05% twice daily
Desoximetasone 0.25% once daily	Experimental	Desoximetasone topical spray 0.25% administered once daily to affected area	Drug: Desoximetasone 0.25% once daily
Desoximetasone 0.25% twice daily	Experimental	Desoximetasone topical spray 0.25% administered twice daily to affected area	Drug: Desoximetasone 0.25% once daily
Vehicle once daily	Placebo Comparator	Vehicle administered to affected areas once daily	Drug: Vehicle once daily
Vehicle twice daily

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Desoximetasone 0.05% once daily	Drug	Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days	Desoximetasone 0.05% once daily

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28	The primary endpoint was the proportion of patients in each treatment group who were considered a Clinical Success (PGA score of 0 or 1) at Day 28 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation) The primary measure of efficacy was evaluated using those patients eligible for inclusion in the ITT population. On a seven point grade PGA scale a patient will be considered a Clinical Success if: the patient's PGA score is 0 or 1. A score of 0 = Clear or 1= Almost Clear was considered clinical success. A patient will be considered a Clinical Failure if: the patient's PGA score is > 1, the patient was considered to have an insufficient therapeutic response	28 days
Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1).	The proportion of patients in each treatment group who were considered a Treatment Success for the target lesion (a score of 0 or 1 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation)) at Day 28. Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components. A TLS score of 0 = Clear or 1= Almost Clear was considered treatment success.	Day 28

Secondary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline in PGA Score at Day 28 Using the ITT	Physician Global Assessment (PGA) of Psoriasis is scored based on dermatologist's assessment of disease averaged over all lesions of face, genitals, or intertriginous area (i.e., breast fold, gluteal crease, axilla). Overall lesions were graded for plaque formation, induration, erythema, and scaling; range: 0 (clear) to 5 (very severe). The severity score was summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe; 5=very severe). PGA response was defined as 0 (clear) or 1 (almost clear) Higher scores indicate greater severity of disease.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have a definite clinical diagnosis of stable plaque psoriasis involving ≥ 10% of the body surface area (BSA).
Have a combined total lesion severity score (TLSS) of ≥ 7 for the target lesion.
Have a plaque elevation score ≥ 3 of (moderate) for the target lesion.
The target lesion must have an area of at least 5 cm².
Have a Physicians Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.

Exclusion Criteria:

Pregnancy
Current diagnosis of other types of psoriasis other than stable plaque psoriasis or has psoriasis of any kind of the face or scalp that will require active treatment during the study.
History of psoriasis that has been unresponsive to topical corticosteroid therapy.
Dermatological conditions that may interfere with the clinical assessments of the signs and symptoms of psoriasis.
Allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance which would compromise the safety of the patient or the results of the study.
Any condition that would place the study patient at undue risk by participation in the study.
Radiation therapy, antineoplastic agents or immunosuppressant medication within 4 weeks prior to the first dose of study drug.
Treatment with any systemic or photo antipsoriatic therapy, within 8 weeks of the first dose of study drug.
Treatment within 12 weeks (or five half lives, whichever is less) prior to the first dose of study drug with any biological therapies for psoriasis.
Systemic steroids within 4 weeks of the first dose of the study drug. The use of inhaled or intranasal corticosteroids is acceptable as long as usage has been stable for at least 2 weeks prior to the first dose of study drug and will be continued during the study.
Hormonal contraceptives for less than one complete cycle prior to entering the study.
Topical antipsoriatic agents of any kind or any topical corticosteroids for any reason within 2 weeks prior to first use of study drug. Nonprescription antipsoriatic shampoos used only on the scalp will be allowed during the study.
Receipt of any drug as part of a research study within 30 days prior to first dosing.

Facility	Status	City	State	ZIP	Country	Contacts
Investigator Site		Miami	Florida		United States
Investigator Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Desoximetasone 0.05% Once Daily	Desoximetasone topical spray 0.05% administered once daily to affected area Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days
FG001	Desoximetasone 0.05% Twice Daily

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Desoximetasone 0.05% Once Daily	Desoximetasone topical spray 0.05% administered once daily to affected area Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days
BG001	Desoximetasone 0.05% Twice Daily	Desoximetasone topical spray 0.05% administered twice daily to affected area Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days
BG002	Desoximetasone 0.25% Once Daily	Desoximetasone topical spray 0.25% administered once daily to affected area Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days
BG003	Desoximetasone 0.25% Twice Daily	Desoximetasone topical spray 0.25% administered twice daily to affected area Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days
BG004	Vehicle Once Daily	Vehicle administered to affected areas once daily Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days
BG005	Vehicle Twice Daily	Vehicle administered to affected areas twice daily Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days
BG006	Total	Total of all reporting groups

Units	Counts
Participants	BG00030 BG00131 BG00230 BG00329 BG00415 BG00515 BG006150

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

Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28

The primary endpoint was the proportion of patients in each treatment group who were considered a Clinical Success (PGA score of 0 or 1) at Day 28 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation)

The primary measure of efficacy was evaluated using those patients eligible for inclusion in the ITT population.

On a seven point grade PGA scale a patient will be considered a Clinical Success if: the patient's PGA score is 0 or 1.

A score of 0 = Clear or 1= Almost Clear was considered clinical success.

A patient will be considered a Clinical Failure if: the patient's PGA score is > 1, the patient was considered to have an insufficient therapeutic response

The primary measure of efficacy was based on the ITT population. One hundred fifty (150) patients used the study medication and were included in the analysis of safety. Two patients withdrew consent and did not have end of study efficacy procedures performed and were excluded from the efficacy analysis.

Posted

Number

percentage of participants

28 days

ID	Title	Description
OG000	Desoximetasone 0.05% Once Daily	Desoximetasone topical spray 0.05% administered once daily to affected area Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days
OG001	Desoximetasone 0.05% Twice Daily	Desoximetasone topical spray 0.05% administered twice daily to affected area Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days
OG002	Desoximetasone 0.25% Once Daily	Desoximetasone topical spray 0.25% administered once daily to affected area Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days
OG003	Desoximetasone 0.25% Twice Daily	Desoximetasone topical spray 0.25% administered twice daily to affected area Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days
OG004	Vehicle Once Daily	Vehicle administered to affected areas once daily Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days
OG005	Vehicle Twice Daily	Vehicle administered to affected areas twice daily Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days

Units	Counts
Participants	OG00030 OG00130 OG00229 OG003

Title

Denominators

Categories

Title	Measurements
	OG00013.33 OG00110.00 OG00220.69 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG004		t-test, 1 sided		0.4261													No	Superiority or Other
OG001 OG005		t-test, 1 sided		0.4219

Primary

Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1).

The proportion of patients in each treatment group who were considered a Treatment Success for the target lesion (a score of 0 or 1 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation)) at Day 28.

Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components.

A TLS score of 0 = Clear or 1= Almost Clear was considered treatment success.

Posted

Number

percentage of Participants

Day 28

ID	Title	Description
OG000	Desoximetasone 0.05% Once Daily	Desoximetasone topical spray 0.05% administered once daily to affected area Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days
OG001	Desoximetasone 0.05% Twice Daily	Desoximetasone topical spray 0.05% administered twice daily to affected area Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days

Secondary

Mean Change From Baseline in PGA Score at Day 28 Using the ITT

Physician Global Assessment (PGA) of Psoriasis is scored based on dermatologist's assessment of disease averaged over all lesions of face, genitals, or intertriginous area (i.e., breast fold, gluteal crease, axilla). Overall lesions were graded for plaque formation, induration, erythema, and scaling; range: 0 (clear) to 5 (very severe). The severity score was summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe; 5=very severe). PGA response was defined as 0 (clear) or 1 (almost clear) Higher scores indicate greater severity of disease.

The Intent-to-Treat (ITT) population was used for the secondary endpoint analysis.

Posted

Mean

Standard Deviation

units on a scale

Day 28

ID	Title	Description
OG000	Desoximetasone 0.05% Once Daily	Desoximetasone topical spray 0.05% administered once daily to affected area Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days
OG001	Desoximetasone 0.05% Twice Daily	Desoximetasone topical spray 0.05% administered twice daily to affected area Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days

Secondary

Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28

Each lesion was evaluated for 3 components: erythema, plaque elevation, and scaling. Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components.

The Intent-to-Treat (ITT) population was used for the secondary efficacy analysis after 28 days of treatment.

Posted

Mean

Standard Deviation

units on a scale

Day 28

ID	Title	Description
OG000	Desoximetasone 0.05% Once Daily	Desoximetasone topical spray 0.05% administered once daily to affected area Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days
OG001	Desoximetasone 0.05% Twice Daily	Desoximetasone topical spray 0.05% administered twice daily to affected area Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days
OG002	Desoximetasone 0.25% Once Daily	Desoximetasone topical spray 0.25% administered once daily to affected area Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days

Secondary

Mean Change From Baseline in %Body Surface Area (%BSA) Affected at Day 28 (or Early Termination).

Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis.

BSA = SQRT ((height (cm) X weight (kg))/3600) BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared

%Body Surface Area Affected the "Rule of Nine" was be used.

The Intent-to-Treat (ITT) population was used for the secondary efficacy analysis after 28 days of treatment.

Posted

Mean

Standard Deviation

percentage of Body Surface Area Affected

Day 28

ID	Title	Description
OG000	Desoximetasone 0.05% Once Daily	Desoximetasone topical spray 0.05% administered once daily to affected area Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days
OG001	Desoximetasone 0.05% Twice Daily	Desoximetasone topical spray 0.05% administered twice daily to affected area Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days
OG002	Desoximetasone 0.25% Once Daily

Arm/Groups

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Desoximetasone 0.05% Once Daily	Desoximetasone topical spray 0.05% administered once daily to affected area Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days	30	6	30
EG001	Desoximetasone 0.05% Twice Daily	Desoximetasone topical spray 0.05% administered twice daily to affected area Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days	31	2	31
EG002	Desoximetasone 0.25% Once Daily	Desoximetasone topical spray 0.25% administered once daily to affected area Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days	30	7	30
EG003	Desoximetasone 0.25% Twice Daily	Desoximetasone topical spray 0.25% administered twice daily to affected area Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days	29	4	29
EG004	Vehicle Once Daily	Vehicle administered to affected areas once daily Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days	15	5	15
EG005	Vehicle Twice Daily	Vehicle administered to affected areas twice daily Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days	15	6	15

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Application Site Dryness	Skin and subcutaneous tissue disorders	MedDRA 10.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected31 at risk EG0022 events2 affected30 at risk EG0030 events0 affected29 at risk EG004
Application Site Erythema	Skin and subcutaneous tissue disorders	MedDRA 10.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG003
Application Site Irritation	Skin and subcutaneous tissue disorders	MedDRA 10.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected31 at risk EG0021 events1 affected30 at risk EG003
Application Site Pruritus	Skin and subcutaneous tissue disorders	MedDRA 10.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected31 at risk EG0021 events1 affected30 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 10.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG003
Excoriation	Skin and subcutaneous tissue disorders	MedDRA 10.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG003
Folliculitis	Skin and subcutaneous tissue disorders	MedDRA 10.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG003
Furuncle	Skin and subcutaneous tissue disorders	MedDRA 10.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected31 at risk EG0022 events1 affected30 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 10.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG003
Headache	General disorders	MedDRA 10.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected31 at risk EG0021 events1 affected30 at risk EG003
Hypercholesterolaemia	Blood and lymphatic system disorders	MedDRA 10.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG003
Hypertension	Cardiac disorders	MedDRA 10.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG003
Nasopharyngitis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 10.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 10.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG003
Tooth Infection	Infections and infestations	MedDRA 10.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected31 at risk EG0021 events1 affected30 at risk EG003
Tooth Injury	Infections and infestations	MedDRA 10.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG003
Tooth Ache	Infections and infestations	MedDRA 10.0)	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG003
Upper Respiratory Tract Infection	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0)	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected31 at risk EG0020 events0 affected30 at risk EG003

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

ID	Term
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D003907	Dexamethasone
D013259	Steroids, Fluorinated