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A Study of Topical Indigo Naturalis Treatment in Patients With Mild to Moderate Plaque-type Psoriasis

Information source: China Medical University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis

Intervention: Indigo Naturalis (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: China Medical University Hospital

Official(s) and/or principal investigator(s):
Hui man cheng, Principal Investigator, Affiliation: China Medical University Hospital

Overall contact:
Hui-Man Cheng, Phone: 886-4-22052121, Ext: 1689, Email: d2227@mail.cmuh.org.tw

Summary

Psoriasis is a distressing, chronic dermatitis. Plague-type psoriasis is the most common form of the disease, occurring in more than 80% of the cases. This type of psoriasis is characterised by sharply dermatcated, erythematous, scaling plagues that typically affect the elbows, knees, scalp, and intergluteal cleft. Estimates of the prevalence of psoriasis is vary from 0. 5% to 4. 6%, with rate varying between countries and races. The prevalence of psoriasis was about 2% in Taiwan. The cause of psoriasis remains unknown; however, it has been linked to complex interactions between predisposing genes and the environment. Current treatment of psoriasis included topical therapy (eg. topical corticosteroids, tars, anthralin, vitamin D analogues, Retinodes), phototherapy and systemic therapy (eg. Methotrexate, cyclosporine, Retinoids, Biologics). Although beneficial, all have undesirable adverse effects.

Clinical Details

Official title: A Study of Topical Indigo Naturalis Treatment in Patients With Mild to Moderate Plaque-type Psoriasis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change from baseline in Overall Target Plaque Severity Score at 8 weeks

Detailed description: Estimated enrollment: Total of 24 subjects: mild to moderate psoriasis patients will be randomized into treatment group (n=16) placebo group (n=8) Study evaluation: A baseline and end of the study evaluation on the patients will be performed, including physical examination, hemogram and blood biochemical analysis (including glutamic-oxaloacetic transaminase, glutamic-pyruvic transaminase, and creatinine measurement). The baseline and end of the study of total body surface area involvement and Psoriasis Area Severity Index (PASI), PGA, OTPSS scores will be also calculated.

Eligibility

Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- men or women at ages between 20 - 65 years old with at least 6 months diagnosis of

moderate to mild plaque-type psoriasis who have a screening and at time of study agent treatment Psoriasis Global Assessment (PGA)=2-3, and have under 20% of their total body surface area (BSA) involved. , with a target plaque for at least 4 sq cm

- In good general health, as evidenced by physical examination, and hematology and

blood chemistry tests within normal ranges with the exception of liver function test value <=1. 5ULN

- If of childbearing age, agreement to continue using birth control measures for the

duration of the study

- Patients who agreed to participate and signed the consent form

- Patients who agreed to return for follow-up visits and provide all required biopsies.

Exclusion Criteria:

- Currently have non-plaque forms of psoriasis (e. g., erythrodermic, guttate, or

pustular psoriasis), or rebound or flare of chronic plaque psoriasis

- Currently or had history of psoriatic arthritis

- Have current drug-induced psoriasis (e. g., a new onset of psoriasis or an

exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).

- Are pregnant, nursing, or planning pregnancy (both men and women) while enrolled in

the study.

- Have used any biologic within the previous 3 months or 5 times the half-life of the

biologic, whichever is longer

- Have received phototherapy or any systemic treatment that could affect psoriasis

(including, but not limited to, (eg, retinoids, methotrexate, cyclosporine, psoralens, sulfasalazine, hydroxyurea, fumaric acid derivatives, herbal treatment or traditional Chinese medicine) within 4 weeks of receiving study treatment

- Have used topical treatment that could affect psoriasis (eg. corticosteroid

tazarotene, and tacrolimus, tar, anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, methoxsalen, trimethylpsoralens, topical traditional Chinese medicines) within 2 weeks of receiving study treatment

- Have used any systemic immunosuppressants (eg, MTX, azathioprine, cyclosporine,

6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) within 4 weeks of receiving study treatment

- Are currently receiving lithium, antimalarials, or intramuscular gold, or have

received lithium, antimalarials, or intramuscular gold within 4 weeks of receiving study treatment

- Positive screening tests for HIV, hepatitis B surface antigen, or hepatitis C

antibody

- A history of alcohol or other drug abuse

- Clinically significant laboratory abnormality in blood, renal function, or liver

function

- A history of sensitivity to Chinese herbs, olive oil, yellow wax, or petroleum jelly

- Have current signs or symptoms of severe, progressive, or uncontrolled renal,

hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease

- Be participating in another trial using an investigational agent or procedure.

- Any other conditions that in the view of investigator, the subject should not be

enrolled.

Locations and Contacts

Hui-Man Cheng, Phone: 886-4-22052121, Ext: 1689, Email: d2227@mail.cmuh.org.tw

China Medical University Hospital,, Taichung,, Taiwan; Recruiting
Hui-Man Cheng, Email: d2227@mail.cmuh.org.tw
Additional Information

Starting date: February 2013
Last updated: July 16, 2013

Page last updated: August 23, 2015

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