We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has suspended participant recruitment.
(Sponsor seeking additional financial support before starting the study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01368887
First Posted: June 8, 2011
Last Update Posted: June 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
DermiPsor, Ltd.
  Purpose
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.

Condition Intervention Phase
Psoriasis Drug: DPS-102 Other: Vehicle / Placebo Drug: Calcipotriol Monotherapy Drug: Nicotinamide Monotherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Phase II Study of a Non-Steroidal Novel Treatment for Scalp Psoriasis

Resource links provided by NLM:


Further study details as provided by DermiPsor, Ltd.:

Primary Outcome Measures:
  • 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. [ Time Frame: 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.


Secondary Outcome Measures:
  • Review of haematology and blood chemistry test results, and any adverse event reports received. [ Time Frame: 12 weeks ]
    Number of participants who experience adverse events and type of adverse event in each case.


Estimated Enrollment: 160
Study Start Date: April 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01368887


Locations
United States, Massachusetts
Boston VA Hospital
Boston, Massachusetts, United States, 02130
Brockton VA Hospital
Brockton, Massachusetts, United States, 02301
Sponsors and Collaborators
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
  More Information

Responsible Party: Shay Marcus, VP Business Development & Marketing, DermiPsor Ltd.
ClinicalTrials.gov Identifier: NCT01368887     History of Changes
Other Study ID Numbers: DermiPsor 2008-103
First Submitted: June 6, 2011
First Posted: June 8, 2011
Last Update Posted: June 8, 2011
Last Verified: June 2011

Keywords provided by DermiPsor, Ltd.:
psoriasis
scalp psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcipotriene
Niacinamide
Niacin
Nicotinic Acids
Dermatologic Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents