Curcuminoids for the Treatment of Chronic Psoriasis Vulgaris

ID: NCT00235625
Status: Completed
Phase: Phase 2
Start Date: October 01, 2005
First Submitted: October 06, 2005
Last Updated: December 12, 2007
Results: N/A
Sponsors & Collaborators: University of Pennsylvania
Location: United States
Conditions: Psoriasis
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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.
Condition or disease Intervention/treatment Phase

Psoriasis

Drug: Curcuminoids C3 Complex®
Other Names
Phase 2

Tracking Information

First Submitted DateOctober 06, 2005
Last Update Posted DateDecember 12, 2007
Start DateOctober 01, 2005
Actual Completion DateNovember 01, 2007
Primary Completion DateN/A
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Physicians Global Assessment (PGA) of Change [Time Frame: November 2007]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • PASI (Psoriasis Area Severity Index) [Time Frame: November 2007]

  • quality of life (Skindex-29) [Time Frame: November 2007]

  • pharmacodynamic activity (via skin biopsies and serum cytokines) [Time Frame: December 2007]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleCurcuminoids for the Treatment of Chronic Psoriasis Vulgaris
Official TitleA Phase II Open Label Study of the Safety and Efficacy of Curcuminoids C3 Complex® in Patients With Chronic Psoriasis Vulgaris.
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.

Study TypeInterventional
Study PhasePhase 2
Estimated Enrollment
12
Allocation
Non-Randomized
Interventional Model
Single Group Assignment
Masking
None
Primary Purpose
Treatment
Conditions
Psoriasis
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Curcuminoids C3 Complex®

Other Names
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Completed
Enrollment12
Completion DateNovember 01, 2007
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
GenderAll
Age18 Years to 75 Years
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT00235625
Other Study ID Numbers
803489
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyN/A
Study Sponsor
University of Pennsylvania
Collaborators
Not Available
Investigators
Principal Investigator
Joel M Gelfand, MD/MSCE
University of Pennsylvania