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Phase 4 N=20 Randomized Single-blind Other

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

Plaque Psoriasis

Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Subjective Subject Preference Survey for the First Treatment Session — 81.1; 77.6 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Taclonex (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Wake Forest University
Primary completion
Sep 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Subjective Subject Preference Survey for the First Treatment Session
81.1; 77.6
PRIMARY
Subjective Subject Preference Survey for the Second Treatment Session
78.9; 69.4

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01707043). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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