Trial to Assess the Potency of SOR007 Ointment in a Psoriasis Plaque Test

Summary

Evaluation of safety, pharmacokinetics, and anti-psoriatic efficacy to assess SOR007 Ointment in topical formulations

Timeline

Start

2016-08

Primary completion

2017-02-13

Completion

2017-02-13

Publications

• Background Parisi R, Symmons DP, Griffiths CE, Ashcroft DM; Identification and Management of Psoriasis and Associated ComorbidiTy (IMPACT) project team. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 2013 Feb;133(2):377-85. doi: 10.1038/jid.2012.339. Epub 2012 Sep 27.
• Background Nestle FO, Di Meglio P, Qin JZ, Nickoloff BJ. Skin immune sentinels in health and disease. Nat Rev Immunol. 2009 Oct;9(10):679-91. doi: 10.1038/nri2622. Epub 2009 Sep 18.
• Background Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009 Jul 30;361(5):496-509. doi: 10.1056/NEJMra0804595. No abstract available.
• Background Schiff PB, Horwitz SB. Taxol stabilizes microtubules in mouse fibroblast cells. Proc Natl Acad Sci U S A. 1980 Mar;77(3):1561-5. doi: 10.1073/pnas.77.3.1561.
• Background Mirzapoiazova T, Kolosova IA, Moreno L, Sammani S, Garcia JG, Verin AD. Suppression of endotoxin-induced inflammation by taxol. Eur Respir J. 2007 Sep;30(3):429-35. doi: 10.1183/09031936.00154206. Epub 2007 May 30.
• Background Zhang L, Dermawan K, Jin M, Liu R, Zheng H, Xu L, Zhang Y, Cai Y, Chu Y, Xiong S. Differential impairment of regulatory T cells rather than effector T cells by paclitaxel-based chemotherapy. Clin Immunol. 2008 Nov;129(2):219-29. doi: 10.1016/j.clim.2008.07.013. Epub 2008 Sep 3.
• Background Belotti D, Vergani V, Drudis T, Borsotti P, Pitelli MR, Viale G, Giavazzi R, Taraboletti G. The microtubule-affecting drug paclitaxel has antiangiogenic activity. Clin Cancer Res. 1996 Nov;2(11):1843-9.
• Background Ehrlich A, Booher S, Becerra Y, Borris DL, Figg WD, Turner ML, Blauvelt A. Micellar paclitaxel improves severe psoriasis in a prospective phase II pilot study. J Am Acad Dermatol. 2004 Apr;50(4):533-40. doi: 10.1016/j.jaad.2003.09.018.
• Background Dumas KJ, Scholtz JR. The psoriasis bio-assay for topical corticosteroid activity. Acta Derm Venereol. 1972;52(1):43-8. No abstract available.
• Background Bangha E, Elsner P. Evaluation of topical antipsoriatic treatment by chromametry, visiometry and 20-MHz ultrasound in the psoriasis plaque test. Skin Pharmacol. 1996;9(5):298-306. doi: 10.1159/000211428.
• Background Kvist PH, Svensson L, Hagberg O, Hoffmann V, Kemp K, Ropke MA. Comparison of the effects of vitamin D products in a psoriasis plaque test and a murine psoriasis xenograft model. J Transl Med. 2009 Dec 17;7:107. doi: 10.1186/1479-5876-7-107.
• Background Kragballe K, Noerrelund KL, Lui H, Ortonne JP, Wozel G, Uurasmaa T, Fleming C, Estebaranz JL, Hanssen LI, Persson LM. Efficacy of once-daily treatment regimens with calcipotriol/betamethasone dipropionate ointment and calcipotriol ointment in psoriasis vulgaris. Br J Dermatol. 2004 Jun;150(6):1167-73. doi: 10.1111/j.1365-2133.2004.05986.x.
• Background Kaufmann R, Bibby AJ, Bissonnette R, Cambazard F, Chu AC, Decroix J, Douglas WS, Lowson D, Mascaro JM, Murphy GM, Stymne B. A new calcipotriol/betamethasone dipropionate formulation (Daivobet) is an effective once-daily treatment for psoriasis vulgaris. Dermatology. 2002;205(4):389-93. doi: 10.1159/000066440.
• Background Reich K, Bewley A. What is new in topical therapy for psoriasis? J Eur Acad Dermatol Venereol. 2011 Jun;25 Suppl 4:15-20. doi: 10.1111/j.1468-3083.2011.04061.x.
• Background Schmid-Ott G, Kunsebeck HW, Jager B, Sittig U, Hofste N, Ott R, Malewski P, Lamprecht F. Significance of the stigmatization experience of psoriasis patients: a 1-year follow-up of the illness and its psychosocial consequences in men and women. Acta Derm Venereol. 2005;85(1):27-32. doi: 10.1080/000155550410021583.
• Background Gupta MA, Gupta AK. Age and gender differences in the impact of psoriasis on quality of life. Int J Dermatol. 1995 Oct;34(10):700-3. doi: 10.1111/j.1365-4362.1995.tb04656.x.
• Background Remitz A, Reitamo S, Erkko P, Granlund H, Lauerma AI. Tacrolimus ointment improves psoriasis in a microplaque assay. Br J Dermatol. 1999 Jul;141(1):103-7. doi: 10.1046/j.1365-2133.1999.02927.x.

Drugs

Indications