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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
LEO Pharma
Information provided by (Responsible Party):
Steven R. Feldman, Wake Forest University
ClinicalTrials.gov Identifier:
NCT01707043
First received: October 9, 2012
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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.

The secondary objective is to assess the efficacy 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 Intervention
Plaque Psoriasis
Drug: Taclonex

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Official Title: Patient Preference of Taclonex Ointment to Taclonex Scalp Suspension in Adult Subjects With Psoriasis Vulgaris

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • The patient preference [ Time Frame: one week ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Taclonex Oinment First
All subjects will use Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily for three days to affected areas and Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas for three days in a cross over design. Subjects may continue to use their own non-medicated moisturizer for the course of the study.
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 First
All subjects will use Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily for three days to affected areas and Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas for three days in a cross over design. Subjects may continue to use their own non-medicated moisturizer for the course of the study. Subjects will be evaluated at baseline, Day 3 and Day 6 (or end of study).
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

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 three days, then cross over to use the other product for three days.
  • 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.
  • Subjects will return to the study center at Day 3 (for cross over) and Day 6 (or end of study). At each visit, the subject will be scored for status of the representative target lesion severity and have an Investigator Global Assessment of their current psoriasis condition.
  • 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707043

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
LEO Pharma
Investigators
Principal Investigator: Steve R Feldman, M.D, Ph.D. Wake Forest Baptist Health
Principal Investigator: Alan B Fleischer, Jr, M.D. Wake Forest Baptist Health
Principal Investigator: Adele R Clark, PA-C Wake Forest Baptist Health
  More Information

No publications provided

Responsible Party: Steven R. Feldman, Professor of Dermatology, Wake Forest University
ClinicalTrials.gov Identifier: NCT01707043     History of Changes
Other Study ID Numbers: 21361
Study First Received: October 9, 2012
Last Updated: April 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
plaque psoriasis
taclonex
crossover

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Betamethasone
Betamethasone benzoate
Betamethasone sodium phosphate
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Calcipotriene
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Dermatologic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014