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

NCT ID: NCT01707043

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-12-31

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.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Taclonex Ointment First

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

Group Type: ACTIVE_COMPARATOR

Taclonex

Intervention Type: DRUG

Subjects will be evaluated at baseline, Day 3 and Day 6 (or end of study).

Taclonex Scalp Suspension first

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,

Group Type: ACTIVE_COMPARATOR

Taclonex

Intervention Type: DRUG

Subjects will be evaluated at baseline, Day 3 and Day 6 (or end of study).

Interventions

Taclonex

Subjects will be evaluated at baseline, Day 3 and Day 6 (or end of study).

Intervention Type: DRUG

Other Intervention Names

Taclonex® Ointment; (calcipotriene 0.005% betamethasone dipropionate 0.064%); Taclonex Scalp®; (calcipotriene 0.005% and betamethasone dipropionate 0.064%); Topical Suspension

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: collaborator

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steve R Feldman, M.D, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Alan B Fleischer, Jr, M.D.

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Adele R Clark, PA-C

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00021361

Identifier Type: -

Identifier Source: org_study_id