Double-Blind Study of Topical WBI-1001 Cream on Patients With Psoriasis (WBI-1001-101)
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| First Received Date ICMJE | January 26, 2009 | ||||||||
| Last Updated Date | January 27, 2009 | ||||||||
| Start Date ICMJE | July 2007 | ||||||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Evaluate safety and tolerability of topically applied WBI-1001 cream, and to assess the pharmacokinetics based on plasma concentrations [ Time Frame: 35 days ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00830817 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Obtain initial evaluation of efficacy of topically applied WBI-1001 cream in patients with mild to moderate psoriasis. [ Time Frame: 35 days ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Double-Blind Study of Topical WBI-1001 Cream on Patients With Psoriasis | ||||||||
| Official Title ICMJE | A Randomized, Double-Blind Phase I Study to Evaluate Topically Applied WBI-1001 Cream in Patients With Psoriasis. | ||||||||
| Brief Summary | The purpose of this study is to evaluate primarily the safety and tolerability and secondarily the efficacy of topically applied WBI-1001 cream in patients with mild to moderate psoriasis. Double-blind, randomized, placebo controlled study of 36 patients, treated for 28 days plus a 7 day follow-up.in which the patients were divided into six cohorts: Cohort 1 at 0.5% QD;Cohort 2 at 0.5% BID; Cohort 3 at 1.0% QD; Cohort 4 at 1.0% BID; Cohort 5 at 2.0% QD; Cohort 6 at 2.0% BID.Efficacy assessed by PGA,target lesion assessment and BSA. Safety assessed through vital signs, ECG, AEs and Plasma PK via Cmin, Cmax,Tmax and AUCo-t. |
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| Detailed Description | Patients initiated screening within 4 weeks of commencing study treatment. Based on progression of the study, at day 0 patients were assigned to one of six treatment Cohorts. Patients were randomized to treat all areas except the face, scalp, groin and genital areas. Patients in Cohort 1 were treated on one side with a thin layer of active cream and the other with placebo; in the absence of significant AEs by 14 days after the last treatment in the Cohort escalation to the next Cohort was allowed, and each Cohort respectively. During the treatment period patients visited the study centre weekly for safety, tolerability and efficacy assessment. On these study visit days blood draws were done between 7.00 and 10.00am prior to that morning's application of cream. The study enrolled healthy male and female patients aged 18-65 y.o. with clinical diagnosis of stable plaque psoriasis for >months affecting a maximum of 6% of BSA with a minimum of 0.5% BSA on each side of the body and a minimum of one plaque at least 2x2 cm on each side excluding elbow and knee. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: Blood plasma samples retained following PK analyses. |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Males and female18-65 yo. inclusive Mild to moderate plaque psoriasis |
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| Condition ICMJE | Psoriasis | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 36 | ||||||||
| Completion Date | June 2008 | ||||||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00830817 | ||||||||
| Other Study ID Numbers ICMJE | WBI-1001-101; control # 114963 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Robert Bissonnette; Principal Investigator, Innovaderm Research, Inc., | ||||||||
| Study Sponsor ICMJE | Welichem Biotech Inc. | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Welichem Biotech Inc. | ||||||||
| Verification Date | January 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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