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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:
Information provided by:
DermiPsor, Ltd.
ClinicalTrials.gov Identifier:
NCT01368887
First received: June 6, 2011
Last updated: June 7, 2011
Last verified: June 2011

June 6, 2011
June 7, 2011
April 2013
November 2013   (final data collection date for primary outcome 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01368887 on ClinicalTrials.gov Archive Site
Review of haematology and blood chemistry test results, and any adverse event reports received. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Number of participants who experience adverse events and type of adverse event in each case.
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Psoriasis
  • 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.
  • 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.
  • 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.
  • 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.
  • Experimental: 1
    DPS-102
    Intervention: Drug: DPS-102
  • Placebo Comparator: 2
    Vehicle
    Intervention: Other: Vehicle / Placebo
  • Active Comparator: 3
    Calcipotriol Monotherapy
    Intervention: Drug: Calcipotriol Monotherapy
  • Active Comparator: 4
    Nicotinamide Monotherapy
    Intervention: Drug: Nicotinamide Monotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
160
April 2014
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01368887
DermiPsor 2008-103
Yes
Shay Marcus, VP Business Development & Marketing, DermiPsor Ltd.
DermiPsor, Ltd.
Not Provided
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
DermiPsor, Ltd.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP