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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373516
• Other study ID #: QRX-101-CLIN-003
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2006
• Last updated: September 6, 2006
• Start date: September 2004
• Est. completion date: March 2005

Study information

• Verified date: September 2006
• Source: QuatRx Pharmaceuticals Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Vehicle (Placebo) applied BID

• QRX-101 75 mcg/g ointment applied QD

• QRX-101 75 mcg/g ointment applied BID

Locations

Country	Name	City	State
United States	Clinical Research Site	Anderson	South Carolina
United States	Clinical Research Site	Ann Arbor	Michigan
United States	Clinical Research Site	Edina	Minnesota
United States	Clinical Research Site	Hot Springs	Arkansas
United States	Clinical Research Site	Lexington	Kentucky
United States	Clinical Research Site	Louisville	Kentucky
United States	Clinical Research Site	Overland Park	Kansas
United States	Clinical Research Site	San Antonio	Texas
United States	Clinical Research Site	Santa Rosa	California
United States	Clinical Research Site	Simpsonville	South Carolina
United States	Clinical Research Site	Temple	Pennsylvania
United States	Clinical Research Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
QuatRx Pharmaceuticals Company

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Salmhofer W, Maier H, Soyer HP, Hönigsmann H, Hödl 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dichotomized Physician’s Static Global Assessment of Overall Lesion Severity (PGA)at Week 8
Primary	Percent Change from Baseline in Psoriasis Symptom Severity (PSS)Scale at Week 8
Secondary	Dichotomized PGA at weeks 2 and 4
Secondary	Ordinal PGA at weeks 2, 4, and 8
Secondary	Percent change from baseline PSS at weeks 2 and 4
Secondary	Ordinal PSS at weeks 2, 4, and 8
Secondary	Individual symptom scores (erythema, induration, and scaling) at weeks 2, 4, and 8
Secondary	Body surface area (BSA) involvement at weeks 2, 4, and 8