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Study to Test the Effectiveness of a New Treatment for Scalp Psoriasis
Phase II Study of a Non-Steroidal Novel Treatment for Scalp Psoriasis
1 other identifier
interventional
160
1 country
2
Brief Summary
The purpose of this study is to test the effectiveness of DermiPsor's DPS-102 (test product) in patients with scalp Psoroasis. The study is also intended to assess the safety of the product.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2013
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2011
CompletedFirst Posted
Study publicly available on registry
June 8, 2011
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedJune 8, 2011
June 1, 2011
7 months
June 6, 2011
June 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Physician's Global Assessment ("PGA") criteria. The PGA involves a 7 point scale (clear, minimal, mild, moderate, severe and very severe) and grading conducted at 0, 2, 4, 8 and 12 weeks.
The number of participants at each PGA scale level assessed at 0,2,4,8,and 12 weeks and a comparison of each individual's scale assessments over the 12 week period to assess any changes.
12 weeks
Secondary Outcomes (1)
Review of haematology and blood chemistry test results, and any adverse event reports received.
12 weeks
Study Arms (4)
1
EXPERIMENTALDPS-102
2
PLACEBO COMPARATORVehicle
3
ACTIVE COMPARATORCalcipotriol Monotherapy
4
ACTIVE COMPARATORNicotinamide Monotherapy
Interventions
The patient will apply the treatment twice daily in the morning and at bedtime on the involved area only. The scheduled treatment duration is 12 weeks. Patient to begin treatment on the night of Visit 1.
The patient will apply the vehicle twice daily in the morning and at bedtime on the involved area only. The scheduled treatment duration is 12 weeks. Patient to begin treatment on the night of Visit 1.
The patient will apply the treatment twice daily in the morning and at bedtime on the involved area only. The scheduled treatment duration is 12 weeks. Patient to begin treatment on the night of Visit 1.
The patient will apply the treatment twice daily in the morning and at bedtime on the involved area only. The scheduled treatment duration is 12 weeks. Patient to begin treatment on the night of Visit 1.
Eligibility Criteria
You may qualify if:
- Male or female of age 18 or older
- Patient with a personal history of scalp psoriasis
- Patient with treatable lesions
- Patient with a TSS score equal or lower than 9.
- Patient with a PGA score equal or lower than 5.
- Patient agreeing to participate to the study and to sign a written informed consent and comply with study requirements.
You may not qualify if:
- Patient taking systemic niacin or multivitamins within past two weeks
- Patient with PEG (Poly Ethylene Glycol) allergy
- Pregnant or breast feeding female or female who do not use contraception,
- Patient with an history of hypersensitivity to Dovonex/Daivonex
- Patients on Carbamazepine and Primidione (the clearance of Primidione and Carbamazepine may be reduced with the concomitant use of Nicotinamide)
- Patient who is under guardianship, or unable to understand the information (for linguistic or mental reason), or unwilling to give her/his informed consent to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DermiPsor, Ltd.lead
Study Sites (2)
Boston VA Hospital
Boston, Massachusetts, 02130, United States
Brockton VA Hospital
Brockton, Massachusetts, 02301, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shay Marcus
Sponsor / DermiPsor Ltd.
- PRINCIPAL INVESTIGATOR
Nelli Konnikov, M.D.
Veterans Administration (VA) Hospital - Brockton, MA
- PRINCIPAL INVESTIGATOR
Nancy Naguib, M.D.
Brockton VA Hospital
- PRINCIPAL INVESTIGATOR
Carolyn Stanger
Boston VA Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 6, 2011
First Posted
June 8, 2011
Study Start
April 1, 2013
Primary Completion
November 1, 2013
Study Completion
April 1, 2014
Last Updated
June 8, 2011
Record last verified: 2011-06