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

NCT01707043 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00021361
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque Psoriasis

Keywords

plaque psoriasis; taclonex; crossover

Outcome Measures

Primary Outcomes (2)

• Subjective Subject Preference Survey for the First Treatment Session

  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.

  3 days

• Subjective Subject Preference Survey for the Second Treatment Session

  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.

  3 days

Study Arms (2)

Taclonex Ointment First

ACTIVE COMPARATOR

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

Taclonex Scalp Suspension first

ACTIVE COMPARATOR

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

Interventions

Taclonex DRUG

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

Also known as: Taclonex® Ointment, (calcipotriene 0.005% betamethasone dipropionate 0.064%), Taclonex Scalp®, (calcipotriene 0.005% and betamethasone dipropionate 0.064%), Topical Suspension

Taclonex Ointment First; Taclonex Scalp Suspension first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Wake Forest University: lead
• LEO Pharma: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Interventions

betamethasone dipropionate, calcipotriol drug combination; calcipotriene; Suspensions

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Steve Feldman, MD
• Organization: Wake Forest

sfeldman@wakehalth.edu

336-716-3775

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: October 15, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 10, 2018
• Results First Posted: July 11, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)