Safety and Efficacy Study of Two Dose Regimens of Becocalcidiol in the Treatment of Plaque-Type Psoriasis
September 6, 2006 updated by: QuatRx Pharmaceuticals Company
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
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
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment
150
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Hot Springs, Arkansas, United States, 71913
- Clinical Research Site
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California
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Santa Rosa, California, United States, 95404
- Clinical Research Site
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Kansas
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Overland Park, Kansas, United States, 66215
- Clinical Research Site
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Kentucky
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Lexington, Kentucky, United States, 40509
- Clinical Research Site
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Louisville, Kentucky, United States, 40217
- Clinical Research Site
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Michigan
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Ann Arbor, Michigan, United States, 48109
- Clinical Research Site
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Minnesota
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Edina, Minnesota, United States, 55435
- Clinical Research Site
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Clinical Research Site
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Pennsylvania
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Temple, Pennsylvania, United States, 19560
- Clinical Research Site
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South Carolina
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Anderson, South Carolina, United States, 29621
- Clinical Research Site
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Simpsonville, South Carolina, United States, 29681
- Clinical Research Site
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Texas
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San Antonio, Texas, United States, 78229
- Clinical Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Dichotomized Physician's Static Global Assessment of Overall Lesion Severity (PGA)at Week 8
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Percent Change from Baseline in Psoriasis Symptom Severity (PSS)Scale at Week 8
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Secondary Outcome Measures
Outcome Measure |
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Dichotomized PGA at weeks 2 and 4
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Ordinal PGA at weeks 2, 4, and 8
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Percent change from baseline PSS at weeks 2 and 4
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Ordinal PSS at weeks 2, 4, and 8
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Individual symptom scores (erythema, induration, and scaling) at weeks 2, 4, and 8
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Body surface area (BSA) involvement at weeks 2, 4, and 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Krueger G, Koo J, Lebwohl M, Menter A, Stern RS, Rolstad T. The impact of psoriasis on quality of life: results of a 1998 National Psoriasis Foundation patient-membership survey. Arch Dermatol. 2001 Mar;137(3):280-4.
- Barker JN, Ashton RE, Marks R, Harris RI, Berth-Jones J. Topical maxacalcitol for the treatment of psoriasis vulgaris: a placebo-controlled, double-blind, dose-finding study with active comparator. Br J Dermatol. 1999 Aug;141(2):274-8. doi: 10.1046/j.1365-2133.1999.02975.x.
- Bourke JF, Berth-Jones J, Iqbal SJ, Hutchinson PE. High-dose topical calcipotriol in the treatment of extensive psoriasis vulgaris. Br J Dermatol. 1993 Jul;129(1):74-6. doi: 10.1111/j.1365-2133.1993.tb03315.x.
- Bourke JF, Berth-Jones J, Mumford R, Iqbal SJ, Hutchinson PE. High dose topical calcipotriol consistently reduces serum parathyroid hormone levels. Clin Endocrinol (Oxf). 1994 Sep;41(3):295-7. doi: 10.1111/j.1365-2265.1994.tb02548.x.
- Bourke JF, Iqbal SJ, Hutchinson PE. Vitamin D analogues in psoriasis: effects on systemic calcium homeostasis. Br J Dermatol. 1996 Sep;135(3):347-54.
- 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.
- Javitz HS, Ward MM, Farber E, Nail L, Vallow SG. The direct cost of care for psoriasis and psoriatic arthritis in the United States. J Am Acad Dermatol. 2002 Jun;46(6):850-60. doi: 10.1067/mjd.2002.119669.
- Lamba S, Lebwohl M. Combination therapy with vitamin D analogues. Br J Dermatol. 2001 Apr;144 Suppl 58:27-32. doi: 10.1046/j.1365-2133.2001.144s58027.x.
- Lebwohl M, Ali S. Treatment of psoriasis. Part 1. Topical therapy and phototherapy. J Am Acad Dermatol. 2001 Oct;45(4):487-98; quiz 499-502. doi: 10.1067/mjd.2001.117046.
- Salmhofer W, Maier H, Soyer HP, Honigsmann H, Hodl S. Double-blind, placebo-controlled, randomized, right-left study comparing calcipotriol monotherapy with a combined treatment of calcipotriol and diflucortolone valerate in chronic plaque psoriasis. Acta Derm Venereol Suppl (Stockh). 2000;(211):5-8. doi: 10.1080/00015550050500022.
- Helfrich YR, Kang S, Hamilton TA, Voorhees JJ. Topical becocalcidiol for the treatment of psoriasis vulgaris: a randomized, placebo-controlled, double-blind, multicentre study. Br J Dermatol. 2007 Aug;157(2):369-74. doi: 10.1111/j.1365-2133.2007.08037.x. Epub 2007 Jun 26.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Study Completion
March 1, 2005
Study Registration Dates
First Submitted
September 6, 2006
First Submitted That Met QC Criteria
September 6, 2006
First Posted (Estimate)
September 8, 2006
Study Record Updates
Last Update Posted (Estimate)
September 8, 2006
Last Update Submitted That Met QC Criteria
September 6, 2006
Last Verified
September 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- QRX-101-CLIN-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.