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

DermiPsor

Status and phase: Suspended; Phase 2

Conditions: Psoriasis

Treatments: Drug: Calcipotriol Monotherapy; Other: Vehicle / Placebo; Drug: Nicotinamide Monotherapy; Drug: DPS-102

Study type: Interventional

Funder types: Industry

Identifiers

NCT01368887

DermiPsor 2008-103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

DPS-102

Treatment:

Drug: DPS-102

2

Placebo Comparator group

Description:

Vehicle

Treatment:

Other: Vehicle / Placebo

3

Active Comparator group

Description:

Calcipotriol Monotherapy

Treatment:

Drug: Calcipotriol Monotherapy

4

Active Comparator group

Description:

Nicotinamide Monotherapy

Treatment:

Drug: Nicotinamide Monotherapy