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

Condition(s) targeted: Plaque Psoriasis

Intervention: Taclonex (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Wake Forest School of Medicine

Official(s) and/or principal investigator(s):
Steve R Feldman, M.D, Ph.D., Principal Investigator, Affiliation: Wake Forest Baptist Health
Alan B Fleischer, Jr, M.D., Principal Investigator, Affiliation: Wake Forest Baptist Health
Adele R Clark, PA-C, Principal Investigator, Affiliation: Wake Forest Baptist Health

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. The secondary objective is to assess the efficacy 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.

Official title: Patient Preference of Taclonex Ointment to Taclonex Scalp Suspension in Adult Subjects With Psoriasis Vulgaris

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator)

Primary outcome:

The patient preference

The patient preference

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

three days, then cross over to use the other product for three days.

- 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.

- Subjects will return to the study center at Day 3 (for cross over) and Day 6 (or end of

study). At each visit, the subject will be scored for status of the representative target lesion severity and have an Investigator Global Assessment of their current psoriasis condition.

- 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Wake Forest University Health Sciences, Winston Salem, North Carolina 27157, United States

Starting date: October 2012
Last updated: April 15, 2013