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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. Identifier: NCT00373516
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : September 8, 2006
Information provided by:
QuatRx Pharmaceuticals Company

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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Vehicle (Placebo) applied BID Drug: QRX-101 75 mcg/g ointment applied QD Drug: QRX-101 75 mcg/g ointment applied BID Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2004
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Primary Outcome Measures :
  1. Dichotomized Physician's Static Global Assessment of Overall Lesion Severity (PGA)at Week 8
  2. Percent Change from Baseline in Psoriasis Symptom Severity (PSS)Scale at Week 8

Secondary Outcome Measures :
  1. Dichotomized PGA at weeks 2 and 4
  2. Ordinal PGA at weeks 2, 4, and 8
  3. Percent change from baseline PSS at weeks 2 and 4
  4. Ordinal PSS at weeks 2, 4, and 8
  5. Individual symptom scores (erythema, induration, and scaling) at weeks 2, 4, and 8
  6. Body surface area (BSA) involvement at weeks 2, 4, and 8

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00373516

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United States, Arkansas
Clinical Research Site
Hot Springs, Arkansas, United States, 71913
United States, California
Clinical Research Site
Santa Rosa, California, United States, 95404
United States, Kansas
Clinical Research Site
Overland Park, Kansas, United States, 66215
United States, Kentucky
Clinical Research Site
Lexington, Kentucky, United States, 40509
Clinical Research Site
Louisville, Kentucky, United States, 40217
United States, Michigan
Clinical Research Site
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Clinical Research Site
Edina, Minnesota, United States, 55435
United States, North Carolina
Clinical Research Site
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
Clinical Research Site
Temple, Pennsylvania, United States, 19560
United States, South Carolina
Clinical Research Site
Anderson, South Carolina, United States, 29621
Clinical Research Site
Simpsonville, South Carolina, United States, 29681
United States, Texas
Clinical Research Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
QuatRx Pharmaceuticals Company

Frappaz A, Thivolet J. (1993). Calcipotriol in combination with PUVA: A randomized double-blind placebo study in severe psoriasis. European Journal of Dermatology. 3:351-354.

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00373516    
Other Study ID Numbers: QRX-101-CLIN-003
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: September 8, 2006
Last Verified: September 2006
Keywords provided by QuatRx Pharmaceuticals Company:
topical therapy
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases