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

• Sponsor: Wake Forest University
• Collaborator: LEO Pharma
• Information provided by (Responsible Party): Wake Forest University Health Sciences ( Wake Forest University )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Plaque Psoriasis	Drug: Taclonex	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Other
• Official Title: Patient Preference of Taclonex Ointment to Taclonex Scalp Suspension in Adult Subjects With Psoriasis Vulgaris
• Study Start Date: October 2012
• Actual Primary Completion Date: September 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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	Drug: Taclonex; Subjects will be evaluated at baseline, Day 3 and Day 6 (or end of study).; Other Names: Taclonex® Ointment; (calcipotriene 0.005% betamethasone dipropionate 0.064%); Taclonex Scalp®; (calcipotriene 0.005% and betamethasone dipropionate 0.064%); Topical Suspension
Active Comparator: 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,	Drug: Taclonex; Subjects will be evaluated at baseline, Day 3 and Day 6 (or end of study).; Other Names: Taclonex® Ointment; (calcipotriene 0.005% betamethasone dipropionate 0.064%); Taclonex Scalp®; (calcipotriene 0.005% and betamethasone dipropionate 0.064%); Topical Suspension

Outcome Measures

Primary Outcome Measures :

1. Subjective Subject Preference Survey for the First Treatment Session [ Time Frame: 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.
2. Subjective Subject Preference Survey for the Second Treatment Session [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, North Carolina

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Wake Forest University

LEO Pharma

Investigators

• Principal Investigator: Steve R Feldman, M.D, Ph.D.; Wake Forest University Health Sciences
• Principal Investigator: Alan B Fleischer, Jr, M.D.; Wake Forest University Health Sciences
• Principal Investigator: Adele R Clark, PA-C; Wake Forest University Health Sciences

More Information

• Responsible Party: Wake Forest University
• ClinicalTrials.gov Identifier: NCT01707043 History of Changes
• Other Study ID Numbers: IRB00021361
• First Posted: October 15, 2012
• Results First Posted: July 11, 2017
• Last Update Posted: September 10, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):

plaque psoriasis; taclonex; crossover

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate; Calcipotriene; Calcitriol; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Dermatologic Agents; Calcium-Regulating Hormones and Agents; Calcium Channel Agonists; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Vasoconstrictor Agents; Vitamins; Micronutrients; Nutrients; Growth Substances; Bone Density Conservation Agents