Efficacy and Safety of Xamiol® Gel Compared to Calcipotriol Scalp Solution in Patients With Scalp Psoriasis

This study has been completed.

Sponsor:

Information provided by:

LEO Pharma

ClinicalTrials.gov Identifier:

NCT01195831

First received: September 3, 2010

Last updated: April 19, 2012

Last verified: April 2012

History of Changes

Results First Received: March 26, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Investigator); Primary Purpose: Treatment
Condition:	Scalp Psoriasis
Interventions:	Drug: Xamiol® gel Drug: Calcipotriol scalp solution

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study period was 17 September 2010 (date of the first enrolment) to 01 March 2011 (date of last patient out)

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Xamiol® Gel	Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
Calcipotriol Scalp Solution	Calcipotriol (as hydrate) 50 mcg/ml

Participant Flow: Overall Study

	Xamiol® Gel	Calcipotriol Scalp Solution
STARTED	120	124
COMPLETED	112	114
NOT COMPLETED	8	10
Lost to Follow-up	2	4
Withdrawal by Subject	2	2
Adverse Event	4	2
Protocol Violation	0	2

Baseline Characteristics

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Reporting Groups

	Description
Xamiol® Gel	Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
Calcipotriol Scalp Solution	Calcipotriol (as hydrate) 50 mcg/ml
Total	Total of all reporting groups

Baseline Measures

	Xamiol® Gel	Calcipotriol Scalp Solution	Total
Number of Participants [units: participants]	120	124	244
Age [units: years] Mean ± Standard Deviation	39.87 ± 13.145	38.73 ± 11.869	39.29 ± 12.500
Gender [units: participants]
Female	47	55	102
Male	73	69	142
Region of Enrollment [units: participants]
China	120	124	244

Outcome Measures

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1. Primary:

Patients With ”Controlled Disease” in Terms of “Clear” or “Minimal” According to Investigator’s Global Assessment of Disease Severity at Week 4. [ Time Frame: 4 weeks ]

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2. Secondary:

Patients With “Controlled Disease” in Terms of “Clear” or “Minimal” According to Investigator’s Global Assessment of Disease Severity at Week 2 [ Time Frame: 2 weeks ]

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3. Secondary:

Patients With “Controlled Disease” in Terms of “Clear” or “Very Mild” According to Patient’s Global Assessment of Disease Severity at Week 2. [ Time Frame: 2 weeks ]

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4. Secondary:

Patients With "Controlled Disease" in Term of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 4. [ Time Frame: 4 weeks ]

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5. Secondary:

Patients With Success (Total Sign Score ≤1) at Week 4 [ Time Frame: 4 weeks ]

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6. Secondary:

For Each Clinical Sign (Redness, Thickness, Scaliness), the Percentage of Patients With Success (Clinical Score=0) at Week 4 [ Time Frame: 4 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

7. Secondary:

Patients With Success (Patient's Itching Score=None) at Week 4 [ Time Frame: 4 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

8. Secondary:

Evaluation of the Quality of Life [ Time Frame: Baseline to weeks 2 and 4 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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