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

Completed · Phase 4

Conditions studied: Plaque Psoriasis

In brief

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.

Key facts

Study ID

NCT01707043

Run by

Wake Forest University

People needed

20

Starts

2012-10-01

Expected to finish

2013-12-01

Last updated by the study team

2018-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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