Plaque Psoriasis Study in Pediatric Subjects | NCT02186665

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
calcitriol ointment	Experimental	calcitriol 3 mcg/g ointment	Drug: calcitriol ointment
placebo	Placebo Comparator	placebo comparator	Drug: placebo comparator

Name	Type	Description	Arm Group Labels	Other Names
calcitriol ointment	Drug		calcitriol ointment
placebo comparator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success of Investigator's Global Assessment (IGA)	The number of subjects with a minimum improvement of 2 grades from baseline in the IGA score and a severity rating of 0 (clear) of 1 (almost clear) at Week 8 (LOCF). The IGA was evaluated at each visit on the following 0 to 4 point scale: 0 - Clear: No signs of psoriasis except for residual hypopigmentation / hyperpigmentation - Almost Clear: Just perceptible erythema, no induration, and no scaling - Mild: Mild erythema, no induration, and mild or no scaling - Moderate: Moderate erythema, mild induration, and mild or no scaling - Severe: Severe erythema, moderate to severe induration, and scaling of any degree	Baseline to Week 8

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Michael Graeber, MD	Galderma R&D, LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
David Stoll, MD		Beverly Hills	California	90212	United States
Center for Dermatology and Laser Surgery

Results Section

Participant Flow Module

ID	Title	Description
FG000	Calcitriol Ointment	Calcitriol 3 mcg/g Ointment
FG001	Placebo	Placebo comparator

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

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
Female	BG0005 BG0017 BG002

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

Success of Investigator's Global Assessment (IGA)

The number of subjects with a minimum improvement of 2 grades from baseline in the IGA score and a severity rating of 0 (clear) of 1 (almost clear) at Week 8 (LOCF).

The IGA was evaluated at each visit on the following 0 to 4 point scale:

0 - Clear: No signs of psoriasis except for residual hypopigmentation / hyperpigmentation

- Almost Clear: Just perceptible erythema, no induration, and no scaling
- Mild: Mild erythema, no induration, and mild or no scaling
- Moderate: Moderate erythema, mild induration, and mild or no scaling
- Severe: Severe erythema, moderate to severe induration, and scaling of any degree

ITT: All randomized subjects to whom study medication was dispensed.

Posted

Count of Participants

Participants

Baseline to Week 8

ID	Title	Description
OG000	Calcitriol Ointment	Calcitriol 3 mcg/g Ointment
OG001	Placebo	Placebo Comparator

Units	Counts
Participants	OG0008 OG00111

Title

Denominators

Categories

Title	Measurements
	OG0003 OG0017

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	Calcitriol Ointment	Calcitriol 3 mcg/g Ointment			0	8	6	8
EG001	Placebo	Placebo Comparator			0	11	8	11

Other Adverse Events

Term	Organ System	Statistical Information
Abdominal pain upper	Gastrointestinal disorders	EG0001 events1 affected8 at risk EG0010 events0 affected11 at risk
Diarrhea	Gastrointestinal disorders	EG0002 events1 affected8 at risk EG0010 events0 affected11 at risk
Conjuctivitis bacterial	Infections and infestations	EG0001 events1 affected8 at risk EG0010 events0 affected11 at risk
Gastroenteritis	Infections and infestations	EG0001 events1 affected8 at risk EG0010 events0 affected11 at risk
Laryngitis	Infections and infestations	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk
Lice infestation	Infections and infestations	EG0001 events1 affected8 at risk EG0010 events0 affected11 at risk
Molluscum contagiosum	Infections and infestations	EG0001 events1 affected8 at risk EG0010 events0 affected11 at risk
Nasopharyngitis	Infections and infestations	EG0000 events0 affected8 at risk EG0014 events2 affected11 at risk
Upper respiratory tract infection	Infections and infestations	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk
Urinary tract infection	Infections and infestations	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk
Viral infection	Infections and infestations	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk
Arthropod bite	Injury, poisoning and procedural complications	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk
Blood pressure increased	Investigations	EG0000 events0 affected8 at risk EG0012 events1 affected11 at risk
Urine calcium/creatinine ratio increased	Investigations	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk
Myalgia	Musculoskeletal and connective tissue disorders	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk
Hypercalciuria	Renal and urinary disorders	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk
Cough	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected8 at risk EG0012 events2 affected11 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected8 at risk EG0010 events0 affected11 at risk
Pruritus	Skin and subcutaneous tissue disorders	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk
Psoriasis	Skin and subcutaneous tissue disorders	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk
Skin irritation	Skin and subcutaneous tissue disorders	EG0002 events2 affected8 at risk EG0010 events0 affected11 at risk

ID	Title	Description
BG000	Calcitriol Ointment	Calcitriol 3 mcg/g Ointment
BG001	Placebo	Placebo comparator
BG002	Total	Total of all reporting groups