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Curcuminoids for the Treatment of Chronic Psoriasis Vulgaris

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Curcuminoids C3 Complex®
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Alternative Medicine, Psoriasis, Turmeric, Curcumin, Dermatology

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects must have chronic plaque type psoriasis that, in the investigator's opinion is clinically stable and does not require urgent treatment with standard, FDA approved psoriasis therapies. Psoriasis must cover at least 6% of subject's body surface area and lesions must have moderate plaque thickness Subjects must be willing to and have the capacity for giving written informed consent Ages 18 to 75 Subjects must be available for the total duration of the study (16 weeks) Female subjects that are sexually active with male partners must be postmenopausal, surgically incapable of childbearing, or be using a medically acceptable method of contraception throughout the entire study period. Medically acceptable methods of contraception that may be used by the subject and/or partner include oral contraceptives or patch, diaphragms with spermicide, IUD, condom with spermicide, or progestin implant or injection. Females taking oral contraceptives must have taken them consistently for at least two months prior to receiving study medication. All female subjects must consent to a urine pregnancy test at screening and at start of study, which must be negative at both time points. Male subjects who are sexually active with female partners and are capable of fertilization must ensure that their female partners will either be postmenopausal, surgically incapable of childbearing, or will use a medically acceptable method of contraception throughout the entire study period Exclusion Criteria: •Females subjects who are pregnant or nursing a child •Subjects who are sensitive to or allergic to turmeric or curry powder •History of alcohol or drug abuse within 12 months of screening visit •Subjects with rapidly improving or deteriorating psoriasis or the following more variable types of psoriasis: guttate, erythrodermic, or pustular psoriasis •Use of systemic treatments for psoriasis (including methotrexate, cyclosporine, alefacept, adalimumab, efalizumab, infliximab, etanercept, etretinate, systemic steroids and PUVA) within 3 months prior to day 0 or at any time during the study. •Use of topical treatments and UVB therapy for psoriasis (not including non-medicated emollients or shampoos) within 14 days prior to day 0 or at any time during the study period. •Subjects, who have received an experimental drug, used any experimental medical devise within 30 days prior to screening •Clinically significant laboratory abnormalities •Subjects with significant medical comorbidities •Subjects for whom the dose of the following medications has changed within 1 month of day 0: clonidine, digoxin, beta-blockers, lithium, or anti-malarials •Subjects unable to swallow pills •Subject who are unable to adhere to the protocol for any reason

Sites / Locations

  • University of Pennsylvania

Outcomes

Primary Outcome Measures

Physicians Global Assessment (PGA) of Change

Secondary Outcome Measures

PASI (Psoriasis Area Severity Index)
quality of life (Skindex-29)
pharmacodynamic activity (via skin biopsies and serum cytokines)

Full Information

First Posted
October 6, 2005
Last Updated
December 12, 2007
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT00235625
Brief Title
Curcuminoids for the Treatment of Chronic Psoriasis Vulgaris
Official Title
A Phase II Open Label Study of the Safety and Efficacy of Curcuminoids C3 Complex® in Patients With Chronic Psoriasis Vulgaris.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Turmeric (Curcuma Longa) is member of the ginger family and is best known for its culinary use as the major of component of curry powder. The volatile of oils (called curcuminoids) of the turmeric root, however, have anti-inflammatory actions which make them promising candidates for the treatment of psoriasis. For example, curcumin has been shown to improve psoriasis in experiments using in vitro models. Turmeric has been shown to have minimal side effects in doses up to 12 grams per day. The purpose of this study is to determine the safety and to estimate the efficacy of oral Curcuminoid C3 Complex® in patients with chronic psoriasis vulgaris.
Detailed Description
This study is no longer recruiting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Alternative Medicine, Psoriasis, Turmeric, Curcumin, Dermatology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Curcuminoids C3 Complex®
Primary Outcome Measure Information:
Title
Physicians Global Assessment (PGA) of Change
Time Frame
November 2007
Secondary Outcome Measure Information:
Title
PASI (Psoriasis Area Severity Index)
Time Frame
November 2007
Title
quality of life (Skindex-29)
Time Frame
November 2007
Title
pharmacodynamic activity (via skin biopsies and serum cytokines)
Time Frame
December 2007

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must have chronic plaque type psoriasis that, in the investigator's opinion is clinically stable and does not require urgent treatment with standard, FDA approved psoriasis therapies. Psoriasis must cover at least 6% of subject's body surface area and lesions must have moderate plaque thickness Subjects must be willing to and have the capacity for giving written informed consent Ages 18 to 75 Subjects must be available for the total duration of the study (16 weeks) Female subjects that are sexually active with male partners must be postmenopausal, surgically incapable of childbearing, or be using a medically acceptable method of contraception throughout the entire study period. Medically acceptable methods of contraception that may be used by the subject and/or partner include oral contraceptives or patch, diaphragms with spermicide, IUD, condom with spermicide, or progestin implant or injection. Females taking oral contraceptives must have taken them consistently for at least two months prior to receiving study medication. All female subjects must consent to a urine pregnancy test at screening and at start of study, which must be negative at both time points. Male subjects who are sexually active with female partners and are capable of fertilization must ensure that their female partners will either be postmenopausal, surgically incapable of childbearing, or will use a medically acceptable method of contraception throughout the entire study period Exclusion Criteria: •Females subjects who are pregnant or nursing a child •Subjects who are sensitive to or allergic to turmeric or curry powder •History of alcohol or drug abuse within 12 months of screening visit •Subjects with rapidly improving or deteriorating psoriasis or the following more variable types of psoriasis: guttate, erythrodermic, or pustular psoriasis •Use of systemic treatments for psoriasis (including methotrexate, cyclosporine, alefacept, adalimumab, efalizumab, infliximab, etanercept, etretinate, systemic steroids and PUVA) within 3 months prior to day 0 or at any time during the study. •Use of topical treatments and UVB therapy for psoriasis (not including non-medicated emollients or shampoos) within 14 days prior to day 0 or at any time during the study period. •Subjects, who have received an experimental drug, used any experimental medical devise within 30 days prior to screening •Clinically significant laboratory abnormalities •Subjects with significant medical comorbidities •Subjects for whom the dose of the following medications has changed within 1 month of day 0: clonidine, digoxin, beta-blockers, lithium, or anti-malarials •Subjects unable to swallow pills •Subject who are unable to adhere to the protocol for any reason
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel M Gelfand, MD/MSCE
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Curcuminoids for the Treatment of Chronic Psoriasis Vulgaris

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