Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| LEO Pharma | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This is an open label, investigator-blinded, cross over, prospective, single center study of subjects with plaque psoriasis. Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment and Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension will each be applied topically once daily.
The primary objective is to assess the patient preference for Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment compared to Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension in the treatment of plaque psoriasis.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taclonex Ointment First | Active Comparator | All subjects will use Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily for three days to affected areas, then switch to Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas for three days |
|
| Taclonex Scalp Suspension first | Active Comparator | All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas for three days, then switch to Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily for three days to affected areas, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taclonex | Drug | Subjects will be evaluated at baseline, Day 3 and Day 6 (or end of study). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Subject Preference Survey for the First Treatment Session | 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. | 3 days |
| Subjective Subject Preference Survey for the Second Treatment Session | 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. | 3 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Steve R Feldman, M.D, Ph.D. | Wake Forest University Health Sciences | Principal Investigator |
| Alan B Fleischer, Jr, M.D. | Wake Forest University Health Sciences | Principal Investigator |
| Adele R Clark, PA-C | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Taclonex Scalp Suspension First, the Taclonex Ointment | 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. |
| BG001 | Taclonex Ointment First Then Taclonex Scalp Suspension |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Subjective Subject Preference Survey for the First Treatment Session | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 days |
|
data collected at each visit over one week
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Taclonex Ointment | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steve Feldman, MD | Wake Forest | 336-716-3775 | sfeldman@wakehalth.edu |
Not provided
| ID | Term |
|---|---|
| C517164 | betamethasone dipropionate, calcipotriol drug combination |
| C055085 | calcipotriene |
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Taclonex Ointment First, Then Taclonex Scalp Suspension | 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. |
|
|
| Primary | Subjective Subject Preference Survey for the Second Treatment Session | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 days |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Taclonex Scalp Suspension | 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 | 0 | 20 | 0 | 20 | 0 | 20 |
Not provided