Plaque PsoriasisPhase 1NCT03004339
Trial to Assess the Potency of SOR007 Ointment in a Psoriasis Plaque Test
A Phase 1 study testing SOR007 Ointment 2.0%, SOR007 Ointment 1.0% and SOR007 Ointment 0.3% in people with Plaque Psoriasis, run by DFB Soria, LLC at 2 sites in United States.
Trial summary
Evaluation of safety, pharmacokinetics, and anti-psoriatic efficacy to assess SOR007 Ointment in topical formulations Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- SOR007 Ointment 2.0%, SOR007 Ointment 1.0% and SOR007 Ointment 0.3%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2016to 13 Feb 2017
- Phase
- Phase 1
- 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
- men and surgically sterile or post-menopausal (at least since 12 months amenorrhoea) women aged 18 years or older. The non-childbearing potential of women needs to be confirmed by medical record or in writing by a gynecologist, if that is not possible a follicle stimulating hormone (FSH) test will be performed on female subjects to confirm menopause, unless they are receiving hormonal replacement therapy for treatment of menopause symptoms;
- subjects with psoriasis vulgaris in a chronic stable phase and mild to moderate plaque(s) with up to three plaque areas sufficient for six treatment fields;
- the target lesion(s) should be on the trunk or extremities (excluding palms/soles); psoriatic lesion on the knees or elbows are not to be used as a target lesion;
- plaques to be treated should have a comparable psoriatic infiltrate thickness of at least 200 μm;
- the physical examination of the skin must be without disease findings other than psoriasis vulgaris unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical trial;
- male volunteers must agree to sexual abstinence or use adequate contraception when sexually active in combination with their female partners, if they are of childbearing potential. That means the volunteer must be vasectomized or use a condom and his female partner must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, or non-DalKon Shield intra-uterine devices [IUDs]. This applies from signing of the informed consent form until 90 days after the last study drug administration. Methods of contraception must have been effective for at least 30 days on the day of signing the informed consent form. Male volunteers must also refrain from sperm donation from signing of the informed consent form until 90 days after the last study drug administration;
- written informed consent obtained.
Who cannot join
- pregnancy and nursing;
- other skin disease or condition noted on physical examination that is considered by the investigator to be relevant to the outcome of the trial;
- subjects with acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica and pustular psoriasis;
- any topical antipsoriatics on plaques potentially to be treated in this trial (including corticosteroids, vitamin D analogues, immunomodulators, retinoids, dithranol and tar, except for salicylic acid and except for treatment on the face, ears and scalp) in the 4 weeks before first treatment and/or during the trial;
- systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics, retinoids, dimethylfumarate in the three months before first treatment and during the trial;
- systemic treatment with biological treatments: ustekinumab or secukinumab within six months or adalimumab, infliximab and etanercept within three months before first treatment and during the trial;
Show all 18Show fewer
- UV-therapy within four weeks before first treatment and during the trial;
- treatment with systemic or locally acting medications which might have countered or influenced the trial aim (medications which are known to provoke or aggravate psoriasis, e.g. antimalarial drugs, lithium) within eight weeks before first treatment and/or during the trial. Beta-blockers or angiotensin-converting enzyme (ACE) inhibitors are allowed if on a stable dose for 3 months before study medication initiation;
- intake of Anticoagulant Drugs, e.g. Warfarin, Coumadin. Antiplatelet Drugs e.g. Acetyl salicylic acid are permitted unless considered contraindicated by the investigator for blood withdrawal for PK analyses;
- known allergic reactions, irritations or sensitivity to the active ingredients or other components of the IPs;
- known allergic reactions, irritations or sensitivity to the comparator's active ingredient and/or components;
- contraindications according to summary of product characteristics of the active comparator;
- evidence of drug or alcohol abuse;
- symptoms of a clinically significant illness that may place the subject at risk by trial participation or influence the outcome of the trial in the four weeks before first treatment and during the trial;
- participation in the treatment phase of another clinical trial within the last four weeks prior to first treatment in this clinical trial;
- in the opinion of the investigator or physician performing the initial examination the subject should not participate in the trial, e.g. due to probable noncompliance or inability to understand the trial and give adequately informed consent;
- close affiliation with the investigator (e.g. a close relative) or persons working at bioskin GmbH or Modoc or subject is an employee of sponsor;
- subject is institutionalized because of legal or regulatory order.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
DermResearch, Inc.
Austin, Texas, 78759
J&S Studies, Inc.
College Station, Texas, 77845
About this study
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
Evaluation of safety, pharmacokinetics, and anti-psoriatic efficacy to assess SOR007 Ointment in topical formulations
Read the detailed description
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.
- Conditions
- Plaque Psoriasis
- Being tested
- SOR007 Ointment 2.0%, SOR007 Ointment 1.0%, SOR007 Ointment 0.3%, SOR007 Ointment 0.15%, SOR007 Ointment Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOR007 Ointment 2.0%Drug
SOR007 Ointment 1.0%Drug
SOR007 Ointment 0.3%Drug
SOR007 Ointment 0.15%Drug
SOR007 Ointment PlaceboDrug
Taclonex® OintmentDrug
Also called calcipotriene 0.005%/betamethasone dipropionate 0.064%
| Study group | Role | What they receive |
|---|---|---|
| SOR007 Ointment 2.0% | Experimental | Topical application once daily during a 12-day treatment period (10 treatments) Receives: Drug: SOR007 Ointment 2.0% |
| SOR007 Ointment 1.0% | Experimental | Topical application once daily during a 12-day treatment period (10 treatments) Receives: Drug: SOR007 Ointment 1.0% |
| SOR007 Ointment 0.3% | Experimental | Topical application once daily during a 12-day treatment period (10 treatments) Receives: Drug: SOR007 Ointment 0.3% |
| SOR007 Ointment 0.15% | Experimental | Topical application once daily during a 12-day treatment period (10 treatments) Receives: Drug: SOR007 Ointment 0.15% |
| SOR007 Ointment Placebo | Placebo comparator | Topical application once daily during a 12-day treatment period (10 treatments) Receives: Drug: SOR007 Ointment Placebo |
| Taclonex® Ointment | Active comparator | Topical application once daily during a 12-day treatment period (10 treatments) Receives: Drug: Taclonex® Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the thickness of the echolucent band (ELB)
Measured: 12 days
Secondary outcomes (1)
Evaluation of the antipsoriatic efficacy by clinical assessment using a 5-point score
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startAug 2016
- Primary completion13 Feb 2017
- Study completion13 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- DFB Soria, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bioskin GmbH, US Biotest, Inc.
- Responsible party
- Sponsor
- Investigators
- Gere S diZerega, MD, Study chair, US Biotest, Inc./DFB Soria, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004339
- Sponsor's protocol ID
- SOR007-2016-01
- Status last verified
- Feb 2019
- First submitted
- 20 Dec 2016
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23014338Nestle 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.
PubMed 19763149Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009 Jul 30;361(5):496-509. doi: 10.1056/NEJMra0804595. No abstract available.
PubMed 19641206Schiff 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.
PubMed 6103535Mirzapoiazova 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.
PubMed 17537765Zhang 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.
PubMed 18771959Belotti 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.
PubMed 9816139Ehrlich 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.
PubMed 15034502Dumas KJ, Scholtz JR. The psoriasis bio-assay for topical corticosteroid activity. Acta Derm Venereol. 1972;52(1):43-8. No abstract available.
PubMed 4111105Bangha 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.
PubMed 8990504Kvist 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.
PubMed 20017943Kragballe 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.
PubMed 15214905Kaufmann 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.
PubMed 12444337Reich 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.
PubMed 21507079Schmid-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.
PubMed 15848987
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03004339
- Acronym / sponsor ID
- SOR007-2016-01
- Conditions
- Plaque Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- DFB Soria, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Bioskin GmbH, US Biotest, Inc.
- Study start
- Aug 2016
- Primary completion
- 13 Feb 2017 (actual)
- Study completion
- 13 Feb 2017 (actual)
- First posted
- 28 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of safety, pharmacokinetics, and anti-psoriatic efficacy to assess SOR007 Ointment in topical formulations
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SOR007 Ointment 2.0% | Experimental | Drug: SOR007 Ointment 2.0%Topical application once daily during a 12-day treatment period (10 treatments) |
| SOR007 Ointment 1.0% | Experimental | Drug: SOR007 Ointment 1.0%Topical application once daily during a 12-day treatment period (10 treatments) |
| SOR007 Ointment 0.3% | Experimental | Drug: SOR007 Ointment 0.3%Topical application once daily during a 12-day treatment period (10 treatments) |
| SOR007 Ointment 0.15% | Experimental | Drug: SOR007 Ointment 0.15%Topical application once daily during a 12-day treatment period (10 treatments) |
| SOR007 Ointment Placebo | Placebo comparator | Drug: SOR007 Ointment PlaceboTopical application once daily during a 12-day treatment period (10 treatments) |
| Taclonex® Ointment | Active comparator | Drug: Taclonex® OintmentTopical application once daily during a 12-day treatment period (10 treatments) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- men and surgically sterile or post-menopausal (at least since 12 months amenorrhoea) women aged 18 years or older. The non-childbearing potential of women needs to be confirmed by medical record or in writing by a gynecologist, if that is not possible a follicle stimulating hormone (FSH) test will be performed on female subjects to confirm menopause, unless they are receiving hormonal replacement therapy for treatment of menopause symptoms;
- subjects with psoriasis vulgaris in a chronic stable phase and mild to moderate plaque(s) with up to three plaque areas sufficient for six treatment fields;
- the target lesion(s) should be on the trunk or extremities (excluding palms/soles); psoriatic lesion on the knees or elbows are not to be used as a target lesion;
- plaques to be treated should have a comparable psoriatic infiltrate thickness of at least 200 μm;
- the physical examination of the skin must be without disease findings other than psoriasis vulgaris unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical trial;
Key exclusion criteria (18 listed)
- pregnancy and nursing;
- other skin disease or condition noted on physical examination that is considered by the investigator to be relevant to the outcome of the trial;
- subjects with acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica and pustular psoriasis;
- any topical antipsoriatics on plaques potentially to be treated in this trial (including corticosteroids, vitamin D analogues, immunomodulators, retinoids, dithranol and tar, except for salicylic acid and except for treatment on the face, ears and scalp) in the 4 weeks before first treatment and/or during the trial;
- systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics, retinoids, dimethylfumarate in the three months before first treatment and during the trial;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOR007 Ointment 2.0% | Drug | SOR007 Ointment 2.0% |
| SOR007 Ointment 1.0% | Drug | SOR007 Ointment 1.0% |
| SOR007 Ointment 0.3% | Drug | SOR007 Ointment 0.3% |
| SOR007 Ointment 0.15% | Drug | SOR007 Ointment 0.15% |
| SOR007 Ointment Placebo | Drug | SOR007 Ointment Placebo |
| Taclonex® OintmentAlso: calcipotriene 0.005%/betamethasone dipropionate 0.064% | Drug | Taclonex® Ointment |
Primary outcome
Change in the thickness of the echolucent band (ELB)
Time frame: 12 days
1 secondary outcome
Evaluation of the antipsoriatic efficacy by clinical assessment using a 5-point score
Time frame: 12 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Background: PubMed 23014338Parisi 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: PubMed 19763149Nestle 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: PubMed 19641206Nestle 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: PubMed 6103535Schiff 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: PubMed 17537765Mirzapoiazova 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: PubMed 18771959Zhang 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: PubMed 9816139Belotti 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: PubMed 15034502Ehrlich 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: PubMed 4111105Dumas KJ, Scholtz JR. The psoriasis bio-assay for topical corticosteroid activity. Acta Derm Venereol. 1972;52(1):43-8. No abstract available.
- Background: PubMed 8990504Bangha 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: PubMed 20017943Kvist 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: PubMed 15214905Kragballe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gere S diZerega, MD study chair
US Biotest, Inc./DFB Soria, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SOR007 Ointment 2.0%, SOR007 Ointment 1.0% and SOR007 Ointment 0.3% in people with Plaque Psoriasis, run by DFB Soria, LLC at 2 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 7 inclusion and 18 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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in the thickness of the echolucent band (ELB) (time frame: 12 days). 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 NCT03004339, which also lists 17 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 15 Feb 2019.