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

Primary Purpose

Psoriasis

Status

Suspended

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

DPS-102

Vehicle / Placebo

Calcipotriol Monotherapy

Nicotinamide Monotherapy

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring psoriasis, scalp psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Boston VA Hospital
Brockton VA Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Arm Description

DPS-102

Vehicle

Calcipotriol Monotherapy

Nicotinamide Monotherapy

Outcomes

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.

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.

Number of participants who experience adverse events and type of adverse event in each case.

Full Information

NCT ID

NCT01368887

First Posted

June 6, 2011

Last Updated

June 7, 2011

Sponsor

DermiPsor, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01368887

Brief Title

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

Official Title

Phase II Study of a Non-Steroidal Novel Treatment for Scalp Psoriasis

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Suspended

Why Stopped

Sponsor seeking additional financial support before starting the study

Study Start Date

April 2013 (undefined)

Primary Completion Date

November 2013 (Anticipated)

Study Completion Date

April 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

DermiPsor, Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

psoriasis, scalp psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

DPS-102

Arm Title

Arm Type

Placebo Comparator

Arm Description

Vehicle

Arm Title

Arm Type

Active Comparator

Arm Description

Calcipotriol Monotherapy

Arm Title

Arm Type

Active Comparator

Arm Description

Nicotinamide Monotherapy

Intervention Type

Drug

Intervention Name(s)

DPS-102

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Vehicle / Placebo

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Calcipotriol Monotherapy

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Nicotinamide Monotherapy

Intervention Description

Primary Outcome Measure Information:

Title

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.

Description

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.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Review of haematology and blood chemistry test results, and any adverse event reports received.

Description

Number of participants who experience adverse events and type of adverse event in each case.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shay Marcus

Organizational Affiliation

Sponsor / DermiPsor Ltd.

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Nelli Konnikov, M.D.

Organizational Affiliation

Veterans Administration (VA) Hospital - Brockton, MA

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nancy Naguib, M.D.

Organizational Affiliation

Brockton VA Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Carolyn Stanger

Organizational Affiliation

Boston VA Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boston VA Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02130

Country

United States

Facility Name

Brockton VA Hospital

City

Brockton

State/Province

Massachusetts

ZIP/Postal Code

02301

Country

United States

12. IPD Sharing Statement

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

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