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

• Status: Suspended
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: DermiPsor, Ltd.
• Treatments: Calcipotriene; Niacin; Niacinamide; Nicotinic Acids

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