Skip to main content
OpenTrials
Completed

NCT Number: NCT00373516

Safety and Efficacy Study of Two Dose Regimens of Becocalcidiol 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Research Site, Hot Springs, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vehicle (Placebo) applied BID

Drug

QRX-101 75 mcg/g ointment applied QD

Drug

QRX-101 75 mcg/g ointment applied BID

Drug

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

Sponsors and collaborators

Lead sponsor

QuatRx Pharmaceuticals Company

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2005
First posted
Sep 8, 2006
Registry last updated
Sep 8, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.