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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vehicle (Placebo) applied BID | Drug | |||
| QRX-101 75 mcg/g ointment applied QD | Drug | |||
| QRX-101 75 mcg/g ointment applied BID | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Site | Hot Springs | Arkansas | 71913 | United States | ||
| Clinical Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10468799 | Background | 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. | |
| 8369213 | Background | 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. |
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| 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 |
| 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 |
| 7955435 | Background | 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. |
| 8949424 | Background | 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. |
| Background | 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. |
| 12063481 | 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. |
| 11255325 | Background | 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. |
| 11501510 | Background | 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. |
| 11568737 | Background | 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. |
| 11234559 | Background | 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. |
| 17596167 | Derived | 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. |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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