Study to Test the Effectiveness of a New Treatment for Scalp Psoriasis

Phase II Study of a Non-Steroidal Novel Treatment for Scalp Psoriasis

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.

Study Overview

• Status: Suspended
• Conditions: Psoriasis
• Intervention / Treatment: Drug: DPS-102; Other: Vehicle / Placebo; Drug: Calcipotriol Monotherapy; Drug: Nicotinamide Monotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • Boston VA Hospital
    • Brockton, Massachusetts, United States, 02301
      • Brockton VA Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 2; Vehicle	Other: Vehicle / Placebo; 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.
EXPERIMENTAL: 1; DPS-102	Drug: DPS-102; 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.
ACTIVE_COMPARATOR: 3; Calcipotriol Monotherapy	Drug: Calcipotriol Monotherapy; 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.
ACTIVE_COMPARATOR: 4; Nicotinamide Monotherapy	Drug: Nicotinamide Monotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Review of haematology and blood chemistry test results, and any adverse event reports received.	Number of participants who experience adverse events and type of adverse event in each case.	12 weeks

Collaborators and Investigators

• Sponsor: DermiPsor, Ltd.
• Investigators: 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 record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ANTICIPATED): November 1, 2013
• Study Completion (ANTICIPATED): April 1, 2014

Study Registration Dates

• First Submitted: June 6, 2011
• First Submitted That Met QC Criteria: June 7, 2011
• First Posted (ESTIMATE): June 8, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): June 8, 2011
• Last Update Submitted That Met QC Criteria: June 7, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: psoriasis; scalp psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Dermatologic Agents; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Calcipotriene; Nicotinic Acids; Niacinamide; Niacin
• Other Study ID Numbers: DermiPsor 2008-103