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

Sponsor

DermiPsor, Ltd. (Industry)

Overall Status

Suspended

CT.gov ID

NCT01368887

Collaborator

(none)

160

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

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

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 Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

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

Study Start Date :

Apr 1, 2013

Anticipated Primary Completion Date :

Nov 1, 2013

Anticipated Study Completion Date :

Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

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. [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. [12 weeks]
Number of participants who experience adverse events and type of adverse event in each case.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Boston VA Hospital	Boston	Massachusetts	United States	02130
2	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