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Safety and Efficacy Study of Two Dose Regimens of Becocalcidiol in the Treatment of Plaque-Type Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00373516
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : September 8, 2006
Sponsor:
Information provided by:
QuatRx Pharmaceuticals Company

Tracking Information
First Submitted Date  ICMJE September 6, 2006
First Posted Date  ICMJE September 8, 2006
Last Update Posted Date September 8, 2006
Study Start Date  ICMJE September 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2006)
  • Dichotomized Physician's Static Global Assessment of Overall Lesion Severity (PGA)at Week 8
  • Percent Change from Baseline in Psoriasis Symptom Severity (PSS)Scale at Week 8
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2006)
  • Dichotomized PGA at weeks 2 and 4
  • Ordinal PGA at weeks 2, 4, and 8
  • Percent change from baseline PSS at weeks 2 and 4
  • Ordinal PSS at weeks 2, 4, and 8
  • Individual symptom scores (erythema, induration, and scaling) at weeks 2, 4, and 8
  • Body surface area (BSA) involvement at weeks 2, 4, and 8
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Two Dose Regimens of Becocalcidiol in the Treatment of Plaque-Type Psoriasis
Official Title  ICMJE A Multi-Center, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Study of the Safety and Efficacy of Two Dosing Regimens of QRX-101 (Becocalcidiol) Ointment in the Treatment of Plaque-Type Psoriasis
Brief Summary The purpose of this study is to evaluate the efficacy and safety of two dosing regimens of QRX-101 ointment (75 mcg/g QD and 75mcg/g BID) in the treatment of plaque-type psoriasis when applied topically twice daily for 8 weeks
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: Vehicle (Placebo) applied BID
  • Drug: QRX-101 75 mcg/g ointment applied QD
  • Drug: QRX-101 75 mcg/g ointment applied BID
Study Arms  ICMJE Not Provided
Publications *

*   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
Enrollment  ICMJE
 (submitted: September 6, 2006)
150
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of stable plaque-type psoriasis affecting 2% to 10% of the subject’s body surface area
  • Psoriasis of a severity that is appropriate for treatment with topical therapy; PGA of at least 3 (moderate) at baseline; PSS of at least 7, and with no individual symptom score (erythema, induration, or scaling) less than 2
  • Subject must sign the IRB approved informed consent and agree to follow dosing instructions and complete required clinic visits.

Exclusion Criteria:

  • Pregnant or nursing females
  • Systemic corticosteroids, methotrexate, cyclosporine, systemic retinoids, prolonged sun exposure or ultraviolet light therapy within 4 weeks of dosing
  • Topical corticosteroids, retinoids, calcipotriene, coal tar, anthralin, or any other treatment indicated for psoriasis within 2 weeks of dosing
  • Untreated bacterial, tubercular, fungal or any viral lesion of the skin
  • Biologic agents/monoclonal antibodies in the last 6 months
  • Currently using lithium or plaquenil
  • Currently using a beta-blocking medication or thiazide diuretic and the dose has not been stabilized for at least 6 months
  • History of hypercalcemia or evidence of vitamin D toxicity
  • Current or history of melanoma skin cancer in the past 5 years
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT00373516
Other Study ID Numbers  ICMJE QRX-101-CLIN-003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE QuatRx Pharmaceuticals Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account QuatRx Pharmaceuticals Company
Verification Date September 2006

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