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PsoriasisPhase 2NCT00373516

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

A Phase 2 study testing QRX-101 75 mcg/g ointment applied QD and QRX-101 75 mcg/g ointment applied BID in people with Psoriasis, run by QuatRx Pharmaceuticals Company at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
QRX-101 75 mcg/g ointment applied QD and QRX-101 75 mcg/g ointment applied BID
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
12 sitesUnited States
Study dates
Sep 2004to Mar 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Clinical Research Site

    Anderson, South Carolina, 29621

  • Clinical Research Site

    Ann Arbor, Michigan, 48109

  • Clinical Research Site

    Edina, Minnesota, 55435

  • Clinical Research Site

    Hot Springs, Arkansas, 71913

  • Clinical Research Site

    Lexington, Kentucky, 40509

  • Clinical Research Site

    Louisville, Kentucky, 40217

  • Clinical Research Site

    Overland Park, Kansas, 66215

  • Clinical Research Site

    San Antonio, Texas, 78229

  • Clinical Research Site

    Santa Rosa, California, 95404

  • Clinical Research Site

    Simpsonville, South Carolina, 29681

  • Clinical Research Site

    Temple, Pennsylvania, 19560

  • Clinical Research Site

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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

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

Conditions
Psoriasis
Being tested
Vehicle (Placebo) applied BID, QRX-101 75 mcg/g ointment applied QD, QRX-101 75 mcg/g ointment applied BID
Keywords
psoriasis, topical therapy
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vehicle (Placebo) applied BIDDrug

  • QRX-101 75 mcg/g ointment applied QDDrug

  • QRX-101 75 mcg/g ointment applied BIDDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 (6)

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2006 (estimated)
  2. Study startSep 2004
  3. Study completionMar 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
150 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00373516
Sponsor's protocol ID
QRX-101-CLIN-003
Status last verified
Sep 2006
First submitted
6 Sep 2006
Last updated
8 Sep 2006
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QRX-101 75 mcg/g ointment applied QD and QRX-101 75 mcg/g ointment applied BID in people with Psoriasis, run by QuatRx Pharmaceuticals Company at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dichotomized Physician's Static Global Assessment of Overall Lesion Severity (PGA)at Week 8. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00373516, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2006.

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