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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vehicle (Placebo) applied BID
QRX-101 75 mcg/g ointment applied QD
QRX-101 75 mcg/g ointment applied BID
Sponsored by
QuatRx Pharmaceuticals Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring psoriasis, topical therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site

Outcomes

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

Full Information

First Posted
September 6, 2006
Last Updated
September 6, 2006
Sponsor
QuatRx Pharmaceuticals Company
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1. Study Identification

Unique Protocol Identification Number
NCT00373516
Brief Title
Safety and Efficacy Study of Two Dose Regimens of Becocalcidiol in the Treatment of Plaque-Type Psoriasis
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 Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
QuatRx Pharmaceuticals Company

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
psoriasis, topical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Vehicle (Placebo) applied BID
Intervention Type
Drug
Intervention Name(s)
QRX-101 75 mcg/g ointment applied QD
Intervention Type
Drug
Intervention Name(s)
QRX-101 75 mcg/g ointment applied BID
Primary Outcome Measure Information:
Title
Dichotomized Physician's Static Global Assessment of Overall Lesion Severity (PGA)at Week 8
Title
Percent Change from Baseline in Psoriasis Symptom Severity (PSS)Scale at Week 8
Secondary Outcome Measure Information:
Title
Dichotomized PGA at weeks 2 and 4
Title
Ordinal PGA at weeks 2, 4, and 8
Title
Percent change from baseline PSS at weeks 2 and 4
Title
Ordinal PSS at weeks 2, 4, and 8
Title
Individual symptom scores (erythema, induration, and scaling) at weeks 2, 4, and 8
Title
Body surface area (BSA) involvement at weeks 2, 4, and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Clinical Research Site
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Clinical Research Site
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95404
Country
United States
Facility Name
Clinical Research Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Clinical Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Clinical Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Clinical Research Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Clinical Research Site
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Clinical Research Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Clinical Research Site
City
Temple
State/Province
Pennsylvania
ZIP/Postal Code
19560
Country
United States
Facility Name
Clinical Research Site
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Clinical Research Site
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
Clinical Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10468799
Citation
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.
Results Reference
background
PubMed Identifier
8369213
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. doi: 10.1111/j.1365-2133.1993.tb03315.x.
Results Reference
background
PubMed Identifier
7955435
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. doi: 10.1111/j.1365-2265.1994.tb02548.x.
Results Reference
background
PubMed Identifier
8949424
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
12063481
Citation
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.
Results Reference
background
PubMed Identifier
11255325
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.
Results Reference
background
PubMed Identifier
11501510
Citation
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.
Results Reference
background
PubMed Identifier
11568737
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. doi: 10.1067/mjd.2001.117046.
Results Reference
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PubMed Identifier
11234559
Citation
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.
Results Reference
background
PubMed Identifier
17596167
Citation
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.
Results Reference
derived

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

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