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



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:9/12/2018
Start Date:October 2012
End Date:December 2013

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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.

- 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.

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.
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
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