<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03004339</url>
  </required_header>
  <id_info>
    <org_study_id>SOR007-2016-01</org_study_id>
    <nct_id>NCT03004339</nct_id>
  </id_info>
  <brief_title>Trial to Assess the Potency of SOR007 Ointment in a Psoriasis Plaque Test</brief_title>
  <official_title>A Phase 1 Randomized, Placebo and Active Comparator-controlled Trial, Double-blind for the IPs, Observer-blind for the Active Comparator, to Assess the Potency of SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment in a Psoriasis Plaque Test</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DFB Soria, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bioskin GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>US Biotest, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>DFB Soria, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of safety, pharmacokinetics, and anti-psoriatic efficacy to assess SOR007 Ointment&#xD;
      in topical formulations&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a two-center, randomized, placebo- and active comparator-controlled trial that will&#xD;
      be double-blind for the investigational products (IPs) and observer-blind for the active&#xD;
      comparator with intra-individual comparison of treatments. Twelve male and post-menopausal&#xD;
      female volunteer subjects, aged 18 years or older, with psoriasis vulgaris and mild or&#xD;
      moderate chronic plaque(s) in a stable phase and an area sufficient for six treatment fields,&#xD;
      will be enrolled. SOR007 Ointment will be administered topically at four concentrations&#xD;
      (0.15%, 0.3%, 1%, and 2%), in addition to a placebo ointment (SOR007 without the active&#xD;
      pharmaceutical ingredient) and an active comparator, Taclonex® Ointment (calcipotriene 0.005&#xD;
      % and betamethasone dipropionate 0.064 %). Treatments will be administered once daily, 10&#xD;
      times over a 12-day trial period. Assessments will include safety, pharmacokinetics (PK), and&#xD;
      preliminary efficacy as determined by measurement of psoriatic infiltrate using 22-megahertz&#xD;
      (MHz) sonography as well as clinical scoring on a 5-point scale. Subjects who withdraw early&#xD;
      for reasons unrelated to investigational product adverse events (AEs) will be replaced.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">February 13, 2017</completion_date>
  <primary_completion_date type="Actual">February 13, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the thickness of the echolucent band (ELB)</measure>
    <time_frame>12 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the antipsoriatic efficacy by clinical assessment using a 5-point score</measure>
    <time_frame>12 days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety analysis: Summary of Treatment-Emergent Adverse Events</measure>
    <time_frame>26 days</time_frame>
    <description>Treatment-emergent adverse events (TEAEs), i.e. AEs with an onset or worsening on or after the time of the first investigational product (IP) application, will be reported. TEAEs will be summarized by the number of subjects reporting TEAEs, primary system organ class (SOC), preferred term (PT), severity, and relationship to IP. Summaries will be provided by the relation to a specific treatment test field or as not related to a specific test field. Vital signs parameters will be summarized descriptively by treatment and visit, including changes from screening visit. Only clinical relevance will be listed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pharmacokinetic analysis: Maximum Plasma Concentration of Paclitaxel (Cmax)</measure>
    <time_frame>12 days</time_frame>
    <description>PK levels of paclitaxel in the plasma will be summarized descriptively.</description>
  </other_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>SOR007 Ointment 2.0%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topical application once daily during a 12-day treatment period (10 treatments)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOR007 Ointment 1.0%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topical application once daily during a 12-day treatment period (10 treatments)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOR007 Ointment 0.3%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topical application once daily during a 12-day treatment period (10 treatments)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOR007 Ointment 0.15%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topical application once daily during a 12-day treatment period (10 treatments)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOR007 Ointment Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Topical application once daily during a 12-day treatment period (10 treatments)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Taclonex® Ointment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Topical application once daily during a 12-day treatment period (10 treatments)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SOR007 Ointment 2.0%</intervention_name>
    <arm_group_label>SOR007 Ointment 2.0%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SOR007 Ointment 1.0%</intervention_name>
    <arm_group_label>SOR007 Ointment 1.0%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SOR007 Ointment 0.3%</intervention_name>
    <arm_group_label>SOR007 Ointment 0.3%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SOR007 Ointment 0.15%</intervention_name>
    <arm_group_label>SOR007 Ointment 0.15%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SOR007 Ointment Placebo</intervention_name>
    <arm_group_label>SOR007 Ointment Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Taclonex® Ointment</intervention_name>
    <arm_group_label>Taclonex® Ointment</arm_group_label>
    <other_name>calcipotriene 0.005%/betamethasone dipropionate 0.064%</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  men and surgically sterile or post-menopausal (at least since 12 months amenorrhoea)&#xD;
             women aged 18 years or older. The non-childbearing potential of women needs to be&#xD;
             confirmed by medical record or in writing by a gynecologist, if that is not possible a&#xD;
             follicle stimulating hormone (FSH) test will be performed on female subjects to&#xD;
             confirm menopause, unless they are receiving hormonal replacement therapy for&#xD;
             treatment of menopause symptoms;&#xD;
&#xD;
          -  subjects with psoriasis vulgaris in a chronic stable phase and mild to moderate&#xD;
             plaque(s) with up to three plaque areas sufficient for six treatment fields;&#xD;
&#xD;
          -  the target lesion(s) should be on the trunk or extremities (excluding palms/soles);&#xD;
             psoriatic lesion on the knees or elbows are not to be used as a target lesion;&#xD;
&#xD;
          -  plaques to be treated should have a comparable psoriatic infiltrate thickness of at&#xD;
             least 200 μm;&#xD;
&#xD;
          -  the physical examination of the skin must be without disease findings other than&#xD;
             psoriasis vulgaris unless the investigator considers an abnormality to be irrelevant&#xD;
             to the outcome of the clinical trial;&#xD;
&#xD;
          -  male volunteers must agree to sexual abstinence or use adequate contraception when&#xD;
             sexually active in combination with their female partners, if they are of childbearing&#xD;
             potential. That means the volunteer must be vasectomized or use a condom and his&#xD;
             female partner must either be surgically sterile (hysterectomy or tubal ligation) or&#xD;
             agree to use a reliable method of contraception with a failure rate of less than 1 %&#xD;
             per year when used consistently and correctly such as implants, injectables, combined&#xD;
             oral contraceptives, or non-DalKon Shield intra-uterine devices [IUDs]. This applies&#xD;
             from signing of the informed consent form until 90 days after the last study drug&#xD;
             administration. Methods of contraception must have been effective for at least 30 days&#xD;
             on the day of signing the informed consent form. Male volunteers must also refrain&#xD;
             from sperm donation from signing of the informed consent form until 90 days after the&#xD;
             last study drug administration;&#xD;
&#xD;
          -  written informed consent obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy and nursing;&#xD;
&#xD;
          -  other skin disease or condition noted on physical examination that is considered by&#xD;
             the investigator to be relevant to the outcome of the trial;&#xD;
&#xD;
          -  subjects with acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica&#xD;
             and pustular psoriasis;&#xD;
&#xD;
          -  any topical antipsoriatics on plaques potentially to be treated in this trial&#xD;
             (including corticosteroids, vitamin D analogues, immunomodulators, retinoids,&#xD;
             dithranol and tar, except for salicylic acid and except for treatment on the face,&#xD;
             ears and scalp) in the 4 weeks before first treatment and/or during the trial;&#xD;
&#xD;
          -  systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics, retinoids,&#xD;
             dimethylfumarate in the three months before first treatment and during the trial;&#xD;
&#xD;
          -  systemic treatment with biological treatments: ustekinumab or secukinumab within six&#xD;
             months or adalimumab, infliximab and etanercept within three months before first&#xD;
             treatment and during the trial;&#xD;
&#xD;
          -  UV-therapy within four weeks before first treatment and during the trial;&#xD;
&#xD;
          -  treatment with systemic or locally acting medications which might have countered or&#xD;
             influenced the trial aim (medications which are known to provoke or aggravate&#xD;
             psoriasis, e.g. antimalarial drugs, lithium) within eight weeks before first treatment&#xD;
             and/or during the trial. Beta-blockers or angiotensin-converting enzyme (ACE)&#xD;
             inhibitors are allowed if on a stable dose for 3 months before study medication&#xD;
             initiation;&#xD;
&#xD;
          -  intake of Anticoagulant Drugs, e.g. Warfarin, Coumadin. Antiplatelet Drugs e.g. Acetyl&#xD;
             salicylic acid are permitted unless considered contraindicated by the investigator for&#xD;
             blood withdrawal for PK analyses;&#xD;
&#xD;
          -  known allergic reactions, irritations or sensitivity to the active ingredients or&#xD;
             other components of the IPs;&#xD;
&#xD;
          -  known allergic reactions, irritations or sensitivity to the comparator's active&#xD;
             ingredient and/or components;&#xD;
&#xD;
          -  contraindications according to summary of product characteristics of the active&#xD;
             comparator;&#xD;
&#xD;
          -  evidence of drug or alcohol abuse;&#xD;
&#xD;
          -  symptoms of a clinically significant illness that may place the subject at risk by&#xD;
             trial participation or influence the outcome of the trial in the four weeks before&#xD;
             first treatment and during the trial;&#xD;
&#xD;
          -  participation in the treatment phase of another clinical trial within the last four&#xD;
             weeks prior to first treatment in this clinical trial;&#xD;
&#xD;
          -  in the opinion of the investigator or physician performing the initial examination the&#xD;
             subject should not participate in the trial, e.g. due to probable noncompliance or&#xD;
             inability to understand the trial and give adequately informed consent;&#xD;
&#xD;
          -  close affiliation with the investigator (e.g. a close relative) or persons working at&#xD;
             bioskin GmbH or Modoc or subject is an employee of sponsor;&#xD;
&#xD;
          -  subject is institutionalized because of legal or regulatory order.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gere S diZerega, MD</last_name>
    <role>Study Chair</role>
    <affiliation>US Biotest, Inc./DFB Soria, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>DermResearch, Inc.</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J&amp;S Studies, Inc.</name>
      <address>
        <city>College Station</city>
        <state>Texas</state>
        <zip>77845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>23014338</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19763149</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19641206</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>6103535</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17537765</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18771959</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>9816139</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>15034502</PMID>
  </reference>
  <reference>
    <citation>Dumas KJ, Scholtz JR. The psoriasis bio-assay for topical corticosteroid activity. Acta Derm Venereol. 1972;52(1):43-8. No abstract available.</citation>
    <PMID>4111105</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>8990504</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20017943</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>15214905</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>12444337</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21507079</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>15848987</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>8537157</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10417522</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Betamethasone</mesh_term>
    <mesh_term>Betamethasone Valerate</mesh_term>
    <mesh_term>Betamethasone-17,21-dipropionate</mesh_term>
    <mesh_term>Betamethasone benzoate</mesh_term>
    <mesh_term>Calcipotriene</mesh_term>
    <mesh_term>Betamethasone sodium phosphate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03004339
org study id: SOR007-2016-01
nct id: NCT03004339
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Evaluation of safety, pharmacokinetics, and anti-psoriatic efficacy to assess SOR007 Ointment
      in topical formulations
This is a two-center, randomized, placebo- and active comparator-controlled trial that will
      be double-blind for the investigational products (IPs) and observer-blind for the active
      comparator with intra-individual comparison of treatments. Twelve male and post-menopausal
      female volunteer subjects, aged 18 years or older, with psoriasis vulgaris and mild or
      moderate chronic plaque(s) in a stable phase and an area sufficient for six treatment fields,
      will be enrolled. SOR007 Ointment will be administered topically at four concentrations
      (0.15%, 0.3%, 1%, and 2%), in addition to a placebo ointment (SOR007 without the active
      pharmaceutical ingredient) and an active comparator, Taclonex® Ointment (calcipotriene 0.005
      % and betamethasone dipropionate 0.064 %). Treatments will be administered once daily, 10
      times over a 12-day trial period. Assessments will include safety, pharmacokinetics (PK), and
      preliminary efficacy as determined by measurement of psoriatic infiltrate using 22-megahertz
      (MHz) sonography as well as clinical scoring on a 5-point scale. Subjects who withdraw early
      for reasons unrelated to investigational product adverse events (AEs) will be replaced.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in the thickness of the echolucent band (ELB)
time frame: 12 days
measure: Evaluation of the antipsoriatic efficacy by clinical assessment using a 5-point score
time frame: 12 days
measure: Safety analysis: Summary of Treatment-Emergent Adverse Events
time frame: 26 days
description: Treatment-emergent adverse events (TEAEs), i.e. AEs with an onset or worsening on or after the time of the first investigational product (IP) application, will be reported. TEAEs will be summarized by the number of subjects reporting TEAEs, primary system organ class (SOC), preferred term (PT), severity, and relationship to IP. Summaries will be provided by the relation to a specific treatment test field or as not related to a specific test field. Vital signs parameters will be summarized descriptively by treatment and visit, including changes from screening visit. Only clinical relevance will be listed.
measure: Pharmacokinetic analysis: Maximum Plasma Concentration of Paclitaxel (Cmax)
time frame: 12 days
description: PK levels of paclitaxel in the plasma will be summarized descriptively.
arm group label: SOR007 Ointment 2.0%
arm group type: Experimental
description: Topical application once daily during a 12-day treatment period (10 treatments)
arm group label: SOR007 Ointment 1.0%
arm group type: Experimental
description: Topical application once daily during a 12-day treatment period (10 treatments)
arm group label: SOR007 Ointment 0.3%
arm group type: Experimental
description: Topical application once daily during a 12-day treatment period (10 treatments)
arm group label: SOR007 Ointment 0.15%
arm group type: Experimental
description: Topical application once daily during a 12-day treatment period (10 treatments)
arm group label: SOR007 Ointment Placebo
arm group type: Placebo Comparator
description: Topical application once daily during a 12-day treatment period (10 treatments)
arm group label: Taclonex® Ointment
arm group type: Active Comparator
description: Topical application once daily during a 12-day treatment period (10 treatments)
intervention type: Drug
intervention name: SOR007 Ointment 2.0%
arm group label: SOR007 Ointment 2.0%
intervention type: Drug
intervention name: SOR007 Ointment 1.0%
arm group label: SOR007 Ointment 1.0%
intervention type: Drug
intervention name: SOR007 Ointment 0.3%
arm group label: SOR007 Ointment 0.3%
intervention type: Drug
intervention name: SOR007 Ointment 0.15%
arm group label: SOR007 Ointment 0.15%
intervention type: Drug
intervention name: SOR007 Ointment Placebo
arm group label: SOR007 Ointment Placebo
intervention type: Drug
intervention name: Taclonex® Ointment
arm group label: Taclonex® Ointment
other name: calcipotriene 0.005%/betamethasone dipropionate 0.064%
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gere S diZerega, MD
role: Study Chair
affiliation: US Biotest, Inc./DFB Soria, LLC
facility: 
facility: 
country: United States
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responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Betamethasone
mesh term: Betamethasone Valerate
mesh term: Betamethasone-17,21-dipropionate
mesh term: Betamethasone benzoate
mesh term: Calcipotriene
mesh term: Betamethasone sodium phosphate
sharing ipd: No