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

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ClinicalTrials.gov Identifier: NCT01707043
Recruitment Status : Completed
First Posted : October 15, 2012
Results First Posted : July 11, 2017
Last Update Posted : September 10, 2018
Sponsor:
Collaborator:
LEO Pharma
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Tracking Information
First Submitted Date  ICMJE October 9, 2012
First Posted Date  ICMJE October 15, 2012
Results First Submitted Date  ICMJE January 27, 2017
Results First Posted Date  ICMJE July 11, 2017
Last Update Posted Date September 10, 2018
Study Start Date  ICMJE October 2012
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 12, 2012)
  • The patient preference [ Time Frame: one week ]
    The preference for Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension compared to Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment in the treatment of plaque psoriasis.
  • The patient preference [ Time Frame: one week ]
    The preference for Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension compared to Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment in the treatment of plaque psoriasis. Both products contain the same active ingredients, but are in different vehicles. Therefore it will be patient's perceived outcome of treatment with vehicle preference.
Change History Complete list of historical versions of study NCT01707043 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patient Preference of Taclonex Ointment to Taclonex Scalp Suspension in Adult Subjects With Psoriasis Vulgaris
Official Title  ICMJE Patient Preference of Taclonex Ointment to Taclonex Scalp Suspension in Adult Subjects With Psoriasis Vulgaris
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: Taclonex
  • 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,
    Intervention: Drug: Taclonex
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2012)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01707043
Other Study ID Numbers  ICMJE IRB00021361
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences ( Wake Forest University )
Study Sponsor  ICMJE Wake Forest University
Collaborators  ICMJE LEO Pharma
Investigators  ICMJE
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
PRS Account Wake Forest University Health Sciences
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP