Trial Outcomes & Findings for Patient Preference of Taclonex Ointment to Taclonex Scalp Suspension in Adult Subjects With Psoriasis Vulgaris (NCT NCT01707043)
NCT ID: NCT01707043
Last Updated: 2018-09-10
Results Overview
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.
COMPLETED
PHASE4
20 participants
3 days
2018-09-10
Participant Flow
Participant milestones
| Measure |
Taclonex Scalp Suspension First, Then Taclonex Ointment
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.
|
Taclonex Ointment First, Then Taclonex Scalp Suspension
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patient Preference of Taclonex Ointment to Taclonex Scalp Suspension in Adult Subjects With Psoriasis Vulgaris
Baseline characteristics by cohort
| Measure |
Taclonex Scalp Suspension First, the Taclonex Ointment
n=10 Participants
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.
|
Taclonex Ointment First Then Taclonex Scalp Suspension
n=10 Participants
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
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.5 years
n=93 Participants
|
47 years
n=4 Participants
|
48 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
20 participants
n=4 Participants
|
40 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 3 daysSubjective 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.
Outcome measures
| Measure |
Taclonex Scalp Suspension First Then Taclonex Ointment
n=10 Participants
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.
|
Taclonex Ointment First, Then Taclonex Scalp Suspension
n=10 Participants
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.
|
|---|---|---|
|
Subjective Subject Preference Survey for the First Treatment Session
|
81.1 units on a scale
Standard Deviation 18.4
|
77.6 units on a scale
Standard Deviation 21.2
|
PRIMARY outcome
Timeframe: 3 daysSubjective 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.
Outcome measures
| Measure |
Taclonex Scalp Suspension First Then Taclonex Ointment
n=10 Participants
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.
|
Taclonex Ointment First, Then Taclonex Scalp Suspension
n=10 Participants
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.
|
|---|---|---|
|
Subjective Subject Preference Survey for the Second Treatment Session
|
78.9 units on a scale
Standard Deviation 22.8
|
69.4 units on a scale
Standard Deviation 17.6
|
Adverse Events
Taclonex Ointment
Taclonex Scalp Suspension
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60