Clinical trial NCT01368887: Study to Test the Effectiveness of a New Treatment for Scalp Psoriasis
Official title: Phase II Study of a Non-Steroidal Novel Treatment for Scalp Psoriasis
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Psoriasis
Keywords: psoriasis
scalp psoriasis
Lead sponsor: DermiPsor, Ltd.
Sponsor class: INDUSTRY
First posted: 2011-06-08
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Psoriasis is a non-contagious skin disorder affecting up to 2% of the world population. It is estimated that 26 million people in the U.S. and Europe suffer from psoriasis. Forty percent (40%) of these suffer from psoriasis of the scalp. Currently, there are three primary modalities for the treatment of psoriasis: topical, phototherapy and systemic treatments. While existing treatments provide varying degrees of relief for this illness, they do not provide a long-term cure. Additionally, there is evidence that some of these existing treatments may cause significant side effect. The purpose of this study is to demonstrate that DermiPsor's DPS-102 (test product) is statistically more effective for the treatment of psoriasis current topical treatment options. It is also intended to assess the safety of DPS-102.

Eligibility criteria: Inclusion Criteria:

* 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 with a negative urine pregnancy test at inclusion for women of childbearing potential and using an efficient contraceptive (oral contraceptives, IUD, or tubal ligation)
* Patient agreeing to participate to the study and to sign a written informed consent and comply with study requirements.

Exclusion Criteria:

* Patient treated with topical scalp treatment for scalp psoriasis within two weeks prior to the inclusion in the study (corticoids, retinoids, vitamin D derivatives),
* Patient treated with systemic treatment for psoriasis (biologics, methotrexate, cyclosporine, retinoids) within one month prior to the inclusion in the study
* Patient taking systemic niacin or multivitamins within past two weeks
* Patient who start or modify a treatment with beta-blockers within one month prior to the inclusion in the study
* 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
* Patient who has participated in a clinical trial within three month prior inclusion,
* 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

Primary outcomes:
measure: 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.
timeFrame: 12 weeks
Secondary outcomes:
measure: Review of haematology and blood chemistry test results, and any adverse event reports received.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston VA Hospital
state: Massachusetts
city: Brockton
country: United States
facility: Brockton VA Hospital
state: Massachusetts
Study officials:
affiliation: Sponsor / DermiPsor Ltd.
name: Shay Marcus
role: STUDY_DIRECTOR
affiliation: Veterans Administration (VA) Hospital - Brockton, MA
name: Nelli Konnikov, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Brockton VA Hospital
name: Nancy Naguib, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston VA Hospital
name: Carolyn Stanger
role: PRINCIPAL_INVESTIGATOR
References: