Safety & Effectiveness of Clobex Spray, Followed by Calci... | NCT00658788

NCT00658788

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Treatment	Active Comparator	clobetasol propionate spray 0.05% Other Names: Clobex® Spray 0.05% clobetasol propionate spray, 0.05%, applied topically twice daily calcitriol ointment Other Names: Calcitriol Ointment calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily	Drug: clobetasol propionate spray 0.05% Drug: calcitriol ointment

Name	Type	Description	Arm Group Labels	Other Names
clobetasol propionate spray 0.05%	Drug	clobetasol propionate spray, 0.05%, applied topically twice daily	Study Treatment

Outcomes Module

Measure	Description	Time Frame
Overall Disease Severity Success (ODS)	Success was defined as a one-grade improvement in ODS from baseline.	8 and 12 weeks

Measure	Description	Time Frame
Global Improvement Score		2, 4, 8 and 12 weeks
Signs of Psoriasis - Erythema		2, 4, 8 and 12 weeks
Signs of Psoriasis - Scaling

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Ronald W Gottschalk, MD	Galderma R&D	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Therapeutics Clinical Research		San Diego	California	92123	United States
MedaPhase, Inc.

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Sequential Treatment Regimen	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Clobex® Spray 0.05%

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Sequential Treatment Regimen	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily

Units	Counts
Participants	BG000305

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00048.6± 14.9

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000118
Male	BG000187

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00027
Not Hispanic or Latino	BG000278

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001
Asian	BG0009

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

Overall Disease Severity Success (ODS)

Success was defined as a one-grade improvement in ODS from baseline.

The per protocol population included 170 subjects who completed the 12 week regimen without any major protocol deviations.

Posted

Number

95% Confidence Interval

percentage of participants

8 and 12 weeks

ID	Title	Description
OG000	Sequential Treatment Regimen	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily

Units	Counts
Participants	OG000170

Title

Denominators

Categories

Week 8

Title	Measurements
	OG000100.0(97.9 to 100.0)

Week 12

Title	Measurements
	OG00084.1(77.7 to 89.3)

Secondary

Global Improvement Score

Posted

Number

participants

2, 4, 8 and 12 weeks

ID	Title	Description
OG000	Week 2	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG001	Week 4	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG002	Week 8	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG003	Week 12	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily

Units	Counts

Secondary

Signs of Psoriasis - Erythema

Posted

Number

participants

2, 4, 8 and 12 weeks

ID	Title	Description
OG000	Week 2	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG001	Week 4	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG002	Week 8	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG003	Week 12	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily

Units	Counts

Secondary

Signs of Psoriasis - Scaling

Posted

Number

participants

2, 4, 8 and 12 weeks

ID	Title	Description
OG000	Week 2	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG001	Week 4	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG002	Week 8	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG003	Week 12	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily

Units	Counts

Secondary

Signs of Psoriasis - Plaque Elevation

Posted

Number

participants

2, 4, 8 and 12 weeks

ID	Title	Description
OG000	Week 2	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG001	Week 4	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG002	Week 8	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG003	Week 12	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily

Units	Counts

Secondary

Percent Change From Baseline in Body Surface Area (% BSA) Affected

Posted

Mean

Standard Deviation

Percent Change from Baseline

2, 4, 8 and 12 weeks

ID	Title	Description
OG000	Week 2	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG001	Week 4	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG002	Week 8	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG003	Week 12	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily

Units

Secondary

Overall Disease Severity

Posted

Number

participants

2, 4, 8 and 12 weeks

ID	Title	Description
OG000	Week 2	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG001	Week 4	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG002	Week 8	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG003	Week 12	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily

Units	Counts

Secondary

Tolerability Assessment - Pruritus

Posted

Number

participants

Baseline, 2, 4, 8 and 12 weeks

ID	Title	Description
OG000	Baseline	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG001	Week 2	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG002	Week 4	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG003	Week 8	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG004	Week 12	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily

Secondary

Tolerability Assessment - Telangiectasias

Posted

Number

participants

Baseline, 2, 4, 8 and 12 weeks

ID	Title	Description
OG000	Baseline	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG001	Week 2	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG002	Week 4	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG003	Week 8	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG004	Week 12	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily

Secondary

Tolerability Assessment - Stinging/ Burning

Posted

Number

participants

Baseline, 2, 4, 8 and 12 weeks

ID	Title	Description
OG000	Baseline	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG001	Week 2	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG002	Week 4	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG003	Week 8	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG004	Week 12	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily

Secondary

Tolerability Assessment - Skin Atrophy

Posted

Number

participants

Baseline, 2, 4, 8 and 12 weeks

ID	Title	Description
OG000	Baseline	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG001	Week 2	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG002	Week 4	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG003	Week 8	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG004	Week 12	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily

Secondary

Tolerability Assessment - Folliculitis

Posted

Number

participants

Baseline, 2, 4, 8 and 12 weeks

ID	Title	Description
OG000	Baseline	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG001	Week 2	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG002	Week 4	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG003	Week 8	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
OG004	Week 12	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Sequential Treatment Regimen	4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily			9	305	0	305

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Accidental Overdose	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected305 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected305 at risk
Spinal cord injury cervical	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected305 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected305 at risk
Pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected305 at risk
Hemiplegia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected305 at risk
Attention deficit/hyperactivity disorder	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0001 affected305 at risk
Bipolar disorder	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0001 affected305 at risk
Depression	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0001 affected305 at risk

ID	Term
D011565	Psoriasis

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