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ISRCTN
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ISRCTN77412040
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DOI
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10.1186/ISRCTN77412040
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Randomised, observer-blinded, vehicle-controlled trial on the efficacy and safety of a topical indigo naturalis ointment treatment for recalcitrant psoriasis vulgaris
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Scientific title
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Acronym
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N/A
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Serial number at source
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CMRPG 33024
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Study hypothesis
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The topical indigo naturalis ointment is effective for the treatment of recalcitrant psoriasis vulgaris.
Please note that as of 10/04/2007 the trial study design was changed to:
Randomised, observer-blinded, placebo-controlled, intra-patient comparison.
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Lay summary
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Not provided at time of registration
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Ethics approval
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This study protocol was approved by the Institutional Review Board of the Chang Gung Memorial Hospital (ref: CGMH IRB No. 93- 129B).
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Study design
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Randomised, double-blind, placebo-controlled, intra-patient comparison
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Countries of recruitment
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Taiwan
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Disease/condition/study domain
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Recalcitrant chronic plaque psoriasis
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Participants - inclusion criteria
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1. Participants with bilateral symmetric, chronic plaque-type psoriasis
2. Participants who have a history of plaque psoriasis for a minimum of two years
3. Participants who have a history of resistance to at least two topical treatments (e.g. corticosteroid and vitamin D3 analogues)
4. Participants who have good general health and normal full blood picture, renal, and liver function in tests done before starting the study
5. Participants of childbearing age who agree to continue using birth control measures for the duration of the study
6. Males and females between 18 and 75 years
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Participants - exclusion criteria
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1. Chronic plaque psoriasis involving more than 60% of the body surface
2. Pustular or generalised erythrodermic psoriasis
3. Use of medications, which affect psoriasis during the study (e.g. systemic therapy including retinoids, methotrexate, cyclosporine, or corticosteroid and non-corticosteroid topical therapy, including vitamin D analogues, tazarotene, tacrolimus)
4. Systemic therapy for psoriasis within 30 days of baseline
5. Ultra-Violet (UV) light therapy within 21 days of baseline
6. Topical therapy within 14 days of baseline
7. Participants that test positive for Human Immunodeficiency Virus (HIV), hepatitis B surface antigen, or hepatitis C
8. Participants that have a current history of alcohol or drug abuse
9. Participants that have a history of hepatitis
10. Participants that have a clinically significant laboratory abnormality
11. Participants that have a history of sensitivity to Chinese herbs, olive oil, yellow wax and Vaseline
12. Female participants who are lactating, pregnant or planning to become pregnant
13. Participants that have participated in another clinical trial in the last 30 days
14. Participants who are unwilling to comply with study protocol
15. Any other conditions, which in the opinion of the investigators could compromise the study
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Anticipated start date
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01/05/2004
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Anticipated end date
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30/04/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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40
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Interventions
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Forty patients with recalcitrant psoriasis vulgaris were treated with indigo naturalis ointment and ointment vehicles were applied daily to either of two bilaterally symmetrical plaques for 12 weeks. Every two weeks, the investigators evaluate the treated plaques. (As of 10/04/07 the following sentence should be disregarded: the patients and investigators were blinded as to the content of the two bottles).
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Primary outcome measure(s)
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Clinical and laboratory assessments were done at baseline and every two weeks thereafter until 12 weeks after the start therapy. The changes in Erythema, Scaling, Indurations (ESI) and and bilateral plaque areas are recorded from the beginning to end of the treatments. Erythema (redness), scaling and indurations (thickening), are scored on a 0 to 8 scale (where 0 = none and 8 = very severe); the sum of these scores for each target lesion is the ESI score. The bilateral plaque area is rated from of 0% to 100% (0% = clearance and 100% = baseline).
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Secondary outcome measure(s)
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Investigators will take biopsies from each treated lesion and analysis the immunohistochemical stains for markers of proliferation, differentiation and inflammation at the end of treatment.
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Sources of funding
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Chang Gung Memorial Hospital (Taiwan) (ref: CMRPG 33024)
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Trial website
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Publications
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2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19015420
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Contact name
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Dr
Yin-ku
Lin
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Address
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123 Ding-Hu road
Kuei-Shan
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City/town
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Taoyuan
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Zip/Postcode
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333
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Country
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Taiwan
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Email
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lin1266@adm.cgmh.org.tw
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Sponsor
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Chang Gung Memorial Hospital (Taiwan)
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Address
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123 Ding-Hu road
Kuei-Shan
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City/town
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Taoyuan
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Zip/Postcode
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333
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Country
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Taiwan
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Email
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lin1266@adm.cgmh.org.tw
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Sponsor website:
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http://www.cgmh.org.tw
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Date applied
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01/01/2006
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Last edited
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08/09/2011
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Date ISRCTN assigned
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01/03/2006
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