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Patient Preference of Taclonex Ointment to Taclonex Scalp Suspension in Adult Subjects With Psoriasis Vulgaris (PSTaclonex)

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ClinicalTrials.gov Identifier: NCT01707043
Recruitment Status : Completed
First Posted : October 15, 2012
Results First Posted : July 11, 2017
Last Update Posted : September 10, 2018
Sponsor:
Collaborator:
LEO Pharma
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Investigator);   Primary Purpose: Other
Condition Plaque Psoriasis
Intervention Drug: Taclonex
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Taclonex Scalp Suspension First, Then Taclonex Ointment Taclonex Ointment First, Then Taclonex Scalp Suspension
Hide Arm/Group Description

All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas of psoriasis for three days.

Subjects will then cross over to use Taclonex ointment for 3 days. There is no washout between products.

All subjects will use Taclonex Ointment to psoriasis twice daily for 3 days Subjects will then cross over to use Taclonex Scalp Suspension for 3 days.There is no washout between products.
Period Title: Overall Study
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Taclonex Scalp Suspension First, the Taclonex Ointment Taclonex Ointment First Then Taclonex Scalp Suspension Total
Hide Arm/Group Description All subjects will use Taclonex Scalp Suspension first to psoriasis twice daily for 3 days Subjects will then cross over to use Taclonex Ointment for 3 days.There is no washout between products. All subjects will use Taclonex Ointment to psoriasis twice daily for 3 days Subjects will then cross over to use Taclonex Scalp Suspension for 3 days.There is no washout between products. Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
49.5
(29 to 64)
47
(33 to 63)
48
(29 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
2
  20.0%
5
  50.0%
7
  35.0%
Male
8
  80.0%
5
  50.0%
13
  65.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Hispanic or Latino
0
   0.0%
1
  10.0%
1
   5.0%
Not Hispanic or Latino
10
 100.0%
9
  90.0%
19
  95.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
  10.0%
1
   5.0%
White
10
 100.0%
8
  80.0%
18
  90.0%
More than one race
0
   0.0%
1
  10.0%
1
   5.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
20 20 40
1.Primary Outcome
Title Subjective Subject Preference Survey for the First Treatment Session
Hide Description Subjective Subject Preference Survey The Subjective Subject Preference Survey consist of 15 questions relating to patients preference of study drug. The survey includes questions such as how the medication feels to touch, how greasy it is, and time it takes to apply. The final question asks patients to rate the overall appeal of the vehicle. Questions are scored on a 7-point scale, where a score of 1 is extremely unpleasant, 4 is neutral, and a score of 7 is extremely appealing. Total preference score based on the Subjective Subject Preference Survey could range from 15-105.
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Taclonex Scalp Suspension First Then Taclonex Ointment Taclonex Ointment First, Then Taclonex Scalp Suspension
Hide Arm/Group Description:

All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas of psoriasis for three days.

Subjects will then cross over to use Taclonex ointment for 3 days. There is no washout between products.

All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily to affected areas of psoriasis for three days.

Subjects will then cross over to use Taclonex Suspension for 3 days. There is no washout between products.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
81.1  (18.4) 77.6  (21.2)
2.Primary Outcome
Title Subjective Subject Preference Survey for the Second Treatment Session
Hide Description Subjective Subject Preference Survey The Subjective Subject Preference Survey consist of 15 questions relating to patients preference of study drug. The survey includes questions such as how the medication feels to touch, how greasy it is, and time it takes to apply. The final question asks patients to rate the overall appeal of the vehicle. Questions are scored on a 7-point scale, where a score of 1 is extremely unpleasant, 4 is neutral, and a score of 7 is extremely appealing. Total preference score based on the Subjective Subject Preference Survey could range from 15-105.
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Taclonex Scalp Suspension First Then Taclonex Ointment Taclonex Ointment First, Then Taclonex Scalp Suspension
Hide Arm/Group Description:

All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas of psoriasis for three days.

Subjects will then cross over to use Taclonex ointment for 3 days. There is no washout between products.

All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily to affected areas of psoriasis for three days.

Subjects will then cross over to use Taclonex Suspension for 3 days. There is no washout between products.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
78.9  (22.8) 69.4  (17.6)
Time Frame data collected at each visit over one week
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Taclonex Ointment Taclonex Scalp Suspension
Hide Arm/Group Description All subjects will use Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily for three days to affected areas In this arm, subject will give a preference rating for Taclonex Ointment

All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas for three days.

In this arm, subjects will give a preference rating for the Suspension

All-Cause Mortality
Taclonex Ointment Taclonex Scalp Suspension
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Taclonex Ointment Taclonex Scalp Suspension
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Taclonex Ointment Taclonex Scalp Suspension
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Steve Feldman, MD
Organization: Wake Forest
Phone: 336-716-3775
Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
ClinicalTrials.gov Identifier: NCT01707043     History of Changes
Other Study ID Numbers: IRB00021361
First Submitted: October 9, 2012
First Posted: October 15, 2012
Results First Submitted: January 27, 2017
Results First Posted: July 11, 2017
Last Update Posted: September 10, 2018