Plaque Psoriasis
Conditions
Keywords
plaque psoriasis, taclonex, crossover
Brief summary
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.
Detailed description
* Following satisfaction of entry criteria, all subjects at the Baseline/Screening visit will be randomized 1:1 to receive either Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment or Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension to use once daily for three days to affected areas of the body, excluding face and intertriginous areas. Subjects will be aware of which product they are using. Investigators will remain blinded. * Subjects will be randomized to use either the ointment or the scalp suspension for the first three day treatment period, then cross over to use the other product for second three day treatment period. * Each medication will be used within its FDA-approved label for the treatment of plaque psoriasis in subjects aged 18 and older. Subjects may not treat areas of the face, axilla or groin in this study. * At the Day 3 and Day 6 visits the subjects will complete a questionnaire about their psoriasis treatment preferences. * Pregnancy tests will be done on females of childbearing potential at Baseline/Screening. * Adverse events will be monitored at each visit.
Interventions
DRUGTaclonex
Subjects will be evaluated at baseline, Day 3 and Day 6 (or end of study).
Sponsors
LEO Pharma
Wake Forest University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject is male or female, age 18 or older, in good health. * Subject has plaque-type psoriasis- no history of or current pustular, erythrodermic or guttate psoriasis. * Subject is capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed. * The percentage of overall body surface involvement is between 1-10% on the trunk or extremities and is amenable to topical treatment with less than 100g of topical medication per week. * The subject has an investigator global assessment of mild to moderate plaque psoriasis (severity index between 2 and 3 on a 5 point scale). * The subject is able to complete the study and comply with study instructions, including attending all study visits. * If a female subject of childbearing potential, subject has a negative urine pregnancy test. Sexually active women of childbearing potential participating in the study must have been using a medically acceptable form of contraception (which includes barrier methods, oral contraception, injectable or implantable methods, or intrauterine devices) for at least three months prior to entry into the study. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. Abstinence is considered an acceptable method of contraception.
Exclusion criteria
* Subject has used experimental drugs or devices at least one month prior to Baseline. * Subject has used systemic corticosteroid, phototherapy, retinoids, methotrexate, cyclosporine, or other immunosuppressive agents or biologics therapy (ie, alefacept, etanercept, efalizumab) within four weeks of Baseline. * Subject has used topical therapy, corticosteroid therapy, topical vitamin D analog or calcineurin inhibitors or , tazarotene within two weeks prior to the Baseline visit (eg, tar, anthralin, salicylic acid, lactic acid, urea preparations). * Subject has other serious skin disorder or any chronic medical condition that is not well controlled. * Subject has clinically relevant abnormal vital signs or findings on the physical examination. * Subject has major illness within 30 days prior to the Baseline visit. * Subject has history of any immunocompromising disease. * Subject is pregnant or nursing. Pregnant and nursing females will not be allowed in the study, and females of childbearing potential will have a pregnancy test at Baseline. * Subject has a skin condition or disease that may require concurrent therapy or may confound the evaluation; a history of hypersensitivity to any of the formulation components; or atopic dermatitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Subject Preference Survey for the First Treatment Session | 3 days | 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. |
| Subjective Subject Preference Survey for the Second Treatment Session | 3 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Taclonex Scalp Suspension First, the Taclonex Ointment | Total | Taclonex Ointment First Then Taclonex Scalp Suspension |
|---|---|---|---|
| Age, Continuous | 49.5 years | 48 years | 47 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 19 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 18 Participants | 8 Participants |
| Region of Enrollment United States | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 2 Participants | 7 Participants | 5 Participants |
| Sex: Female, Male Male | 8 Participants | 13 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Taclonex Scalp Suspension First Then Taclonex Ointment | Subjective Subject Preference Survey for the First Treatment Session | 81.1 units on a scale | Standard Deviation 18.4 |
| Taclonex Ointment First, Then Taclonex Scalp Suspension | Subjective Subject Preference Survey for the First Treatment Session | 77.6 units on a scale | Standard Deviation 21.2 |
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.
Time frame: 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Taclonex Scalp Suspension First Then Taclonex Ointment | Subjective Subject Preference Survey for the Second Treatment Session | 78.9 units on a scale | Standard Deviation 22.8 |
| Taclonex Ointment First, Then Taclonex Scalp Suspension | Subjective Subject Preference Survey for the Second Treatment Session | 69.4 units on a scale | Standard Deviation 17.6 |