PsoriasisPhase 2NCT00235625
Curcuminoids for the Treatment of Chronic Psoriasis Vulgaris
A Phase 2 study testing Curcuminoids C3 Complex® in people with Psoriasis, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Curcuminoids C3 Complex®
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Nov 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- •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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase II Open Label Study of the Safety and Efficacy of Curcuminoids C3 Complex® in Patients With Chronic Psoriasis Vulgaris.
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.
Read the detailed description
This study is no longer recruiting.
- Conditions
- Psoriasis
- Being tested
- Curcuminoids C3 Complex®
- Keywords
- Alternative Medicine, Psoriasis, Turmeric, Curcumin, Dermatology
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcuminoids C3 Complex®Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Physicians Global Assessment (PGA) of Change
Measured: November 2007
Secondary outcomes (3)
PASI (Psoriasis Area Severity Index)
Measured: November 2007
quality of life (Skindex-29)
Measured: November 2007
pharmacodynamic activity (via skin biopsies and serum cytokines)
Measured: December 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startOct 2005
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Investigators
- Joel M Gelfand, MD/MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235625
- Sponsor's protocol ID
- 803489
- Status last verified
- Dec 2007
- First submitted
- 6 Oct 2005
- Last updated
- 17 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open Label Study of the Safety and Efficacy of Curcuminoids C3 Complex® in Patients With Chronic Psoriasis Vulgaris.
- ClinicalTrials.gov ID
- NCT00235625
- Acronym / sponsor ID
- 803489
- Conditions
- Psoriasis
- Keywords
- Alternative Medicine, Psoriasis, Turmeric, Curcumin, Dermatology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Oct 2005
- Study completion
- Nov 2007 (actual)
- First posted
- 10 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (1 listed)
- •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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcuminoids C3 Complex® | Drug | – |
Primary outcome
Physicians Global Assessment (PGA) of Change
Time frame: November 2007
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel M Gelfand, MD/MSCE principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Curcuminoids C3 Complex® in people with Psoriasis, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physicians Global Assessment (PGA) of Change (time frame: November 2007). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2007.