NCT00373516

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2006

Completed
Last Updated

September 8, 2006

Status Verified

September 1, 2006

First QC Date

September 6, 2006

Last Update Submit

September 6, 2006

Conditions

Psoriasis

Keywords

psoriasistopical therapy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Interventions

Vehicle (Placebo) applied BIDDRUG
QRX-101 75 mcg/g ointment applied QDDRUG
QRX-101 75 mcg/g ointment applied BIDDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Clinical Research Site

Hot Springs, Arkansas, 71913, United States

Location

Clinical Research Site

Santa Rosa, California, 95404, United States

Location

Clinical Research Site

Overland Park, Kansas, 66215, United States

Location

Clinical Research Site

Lexington, Kentucky, 40509, United States

Location

Clinical Research Site

Louisville, Kentucky, 40217, United States

Location

Clinical Research Site

Ann Arbor, Michigan, 48109, United States

Location

Clinical Research Site

Edina, Minnesota, 55435, United States

Location

Clinical Research Site

Winston-Salem, North Carolina, 27157, United States

Location

Clinical Research Site

Temple, Pennsylvania, 19560, United States

Location

Clinical Research Site

Anderson, South Carolina, 29621, United States

Location

Clinical Research Site

Simpsonville, South Carolina, 29681, United States

Location

Clinical Research Site

San Antonio, Texas, 78229, United States

Location

Related Publications (11)

  • 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.

    PMID: 10468799BACKGROUND

  • 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.

    PMID: 8369213BACKGROUND

  • 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.

    PMID: 7955435BACKGROUND

  • 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.

    PMID: 8949424BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 12063481BACKGROUND

  • 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.

    PMID: 11255325BACKGROUND

  • 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.

    PMID: 11501510BACKGROUND

  • 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.

    PMID: 11568737BACKGROUND

  • 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.

    PMID: 11234559BACKGROUND

  • 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.

    PMID: 17596167DERIVED

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 8, 2006

Study Start

September 1, 2004

Study Completion

March 1, 2005

Last Updated

September 8, 2006

Record last verified: 2006-09

Locations

US(12)