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

This study has been completed.
Sponsor:
Information provided by:
QuatRx Pharmaceuticals Company
ClinicalTrials.gov Identifier:
NCT00373516
First received: September 6, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by QuatRx Pharmaceuticals Company:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 150
Study Start Date: September 2004
Estimated Study Completion Date: March 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00373516

Locations
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
  More Information

Publications:
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00373516     History of Changes
Other Study ID Numbers: QRX-101-CLIN-003
Study First Received: September 6, 2006
Last Updated: September 6, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by QuatRx Pharmaceuticals Company:
psoriasis
topical therapy

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014