A Phase 4 interventional study of Taclonex in Plaque Psoriasis, sponsored by Wake Forest University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-10.
Sponsored by Wake Forest University · Phase 4, Interventional, and Other
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 20 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Wake Forest University is the lead sponsor of 116 studies on the registry; 7 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 27 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: Taclonex
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,
Drug: Taclonex
Subjects will be evaluated at baseline, Day 3 and Day 6 (or end of study).
Also known as: Taclonex® Ointment, (calcipotriene 0.005% betamethasone dipropionate 0.064%), Taclonex Scalp®, (calcipotriene 0.005% and betamethasone dipropionate 0.064%), Topical Suspension
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.
Time frame: 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.
Time frame: 3 days
| Milestone | Taclonex Scalp Suspension First, Then Taclonex Ointment | Taclonex Ointment First, Then Taclonex Scalp Suspension |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
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.
| units on a scale | Taclonex Scalp Suspension First Then Taclonex Ointment | Taclonex Ointment First, Then Taclonex Scalp Suspension |
|---|---|---|
| Subjective Subject Preference Survey for the First Treatment Session | 81.1 ± 18.4 | 77.6 ± 21.2 |
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.
| units on a scale | Taclonex Scalp Suspension First Then Taclonex Ointment | Taclonex Ointment First, Then Taclonex Scalp Suspension |
|---|---|---|
| Subjective Subject Preference Survey for the Second Treatment Session | 78.9 ± 22.8 | 69.4 ± 17.6 |
Collected over data collected at each visit over one week. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Taclonex Ointment | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Taclonex Scalp Suspension | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Taclonex Scalp Suspension First, the Taclonex Ointment | Taclonex Ointment First Then Taclonex Scalp Suspension | Total |
|---|---|---|---|
| Median | 49.5 (29 to 64) | 47 (33 to 63) | 48 (29 to 64) |
| Sex: Female, Male(Participants) | Taclonex Scalp Suspension First, the Taclonex Ointment | Taclonex Ointment First Then Taclonex Scalp Suspension | Total |
|---|---|---|---|
| Female | 2 | 5 | 7 |
| Male | 8 | 5 | 13 |
| Ethnicity (NIH/OMB)(Participants) | Taclonex Scalp Suspension First, the Taclonex Ointment | Taclonex Ointment First Then Taclonex Scalp Suspension | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 10 | 9 | 19 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Taclonex Scalp Suspension First, the Taclonex Ointment | Taclonex Ointment First Then Taclonex Scalp Suspension | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 10 | 8 | 18 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Taclonex Scalp Suspension First, the Taclonex Ointment | Taclonex Ointment First Then Taclonex Scalp Suspension | Total |
|---|---|---|---|
| United States | 20 | 20 | 40 |
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