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

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:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

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

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:

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.

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.

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.

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. Review.

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.

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.

Lamba S, Lebwohl M. Combination therapy with vitamin D analogues. Br J Dermatol. 2001 Apr;144 Suppl 58:27-32. Review.

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. Review.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2007 Jun 26.

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 June 17, 2013