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CompletedNCT00373516Updated Sep 8, 2006

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

A Phase 2 interventional study of Vehicle (Placebo) applied BID and QRX-101 75 mcg/g ointment applied QD in Psoriasis, sponsored by QuatRx Pharmaceuticals Company. Completed at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-09-08.

Sponsored by QuatRx Pharmaceuticals Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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

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Conditions studied

  • Psoriasis

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Keywords

  • psoriasis
  • topical therapy
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In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 150 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

QuatRx Pharmaceuticals Company is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
150 participants

Interventions

  • DrugVehicle (Placebo) applied BID
  • DrugQRX-101 75 mcg/g ointment applied QD
  • DrugQRX-101 75 mcg/g ointment applied BID
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What researchers measure

Primary outcomes

  1. Dichotomized Physician's Static Global Assessment of Overall Lesion Severity (PGA)at Week 8

  2. Percent Change from Baseline in Psoriasis Symptom Severity (PSS)Scale at Week 8

Secondary outcomes

  1. Dichotomized PGA at weeks 2 and 4

  2. Ordinal PGA at weeks 2, 4, and 8

  3. Percent change from baseline PSS at weeks 2 and 4

  4. Ordinal PSS at weeks 2, 4, and 8

  5. Individual symptom scores (erythema, induration, and scaling) at weeks 2, 4, and 8

  6. Body surface area (BSA) involvement at weeks 2, 4, and 8

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Study locations

12 sites
  • Clinical Research Site
    Hot Springs, Arkansas 71913, United States
  • Clinical Research Site
    Santa Rosa, California 95404, United States
  • Clinical Research Site
    Overland Park, Kansas 66215, United States
  • Clinical Research Site
    Lexington, Kentucky 40509, United States
  • Clinical Research Site
    Louisville, Kentucky 40217, United States
  • Clinical Research Site
    Ann Arbor, Michigan 48109, United States
  • Clinical Research Site
    Edina, Minnesota 55435, United States
  • Clinical Research Site
    Winston-Salem, North Carolina 27157, United States
  • Clinical Research Site
    Temple, Pennsylvania 19560, United States
  • Clinical Research Site
    Anderson, South Carolina 29621, United States
  • Clinical Research Site
    Simpsonville, South Carolina 29681, United States
  • Clinical Research Site
    San Antonio, Texas 78229, United States
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References and documents

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. doi: 10.1046/j.1365-2133.1999.02975.x. PubMed 10468799 ↗
  • 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. PubMed 8369213 ↗
  • 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. PubMed 7955435 ↗
  • 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. PubMed 8949424 ↗
  • 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. PubMed 12063481 ↗
  • 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. PubMed 11255325 ↗
  • 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. PubMed 11501510 ↗
  • 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. PubMed 11568737 ↗
  • 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. PubMed 11234559 ↗
  • 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. PubMed 17596167 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00373516
Lead sponsor
QuatRx Pharmaceuticals Company
First posted
Sep 8, 2006
Start date
Sep 2004
Completion
Mar 2005
Last update
Sep 8, 2006
View the source record on ClinicalTrials.gov ↗

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