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:
DermiPsor, Ltd.
Information provided by:
DermiPsor, Ltd.
ClinicalTrials.gov Identifier:
NCT01368887
First received: June 6, 2011
Last updated: June 7, 2011
Last verified: June 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: DPS-102 Other: Vehicle / Placebo Drug: Calcipotriol Monotherapy Drug: Nicotinamide Monotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Phase II Study of a Non-Steroidal Novel Treatment for Scalp Psoriasis |
Resource links provided by NLM:
Further study details as provided by DermiPsor, Ltd.:
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. [ 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 160 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368887
Locations
| United States, Massachusetts | |
| Boston VA Hospital | |
| Boston, Massachusetts, United States, 02130 | |
| 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 |
More Information
No publications provided
| Responsible Party: | Shay Marcus, VP Business Development & Marketing, DermiPsor Ltd. |
| ClinicalTrials.gov Identifier: | NCT01368887 History of Changes |
| Other Study ID Numbers: | DermiPsor 2008-103 |
| Study First Received: | June 6, 2011 |
| Last Updated: | June 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by DermiPsor, Ltd.:
|
psoriasis scalp psoriasis |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Niacinamide Niacin Nicotinic Acids Calcipotriene Vitamin B Complex Vitamins Micronutrients Growth Substances |
Physiological Effects of Drugs Pharmacologic Actions Vasodilator Agents Cardiovascular Agents Therapeutic Uses Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on May 21, 2013