Contact information
Type
Scientific
Primary contact
Dr Yin-ku Lin
ORCID ID
Contact details
123 Ding-Hu road
Kuei-Shan
Taoyuan
333
Taiwan
lin1266@adm.cgmh.org.tw
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CMRPG 33024
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
This study protocol was approved by the Institutional Review Board of the Chang Gung Memorial Hospital (ref: CGMH IRB No. 93- 129B).
Study design
Randomised, double-blind, placebo-controlled, intra-patient comparison
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Recalcitrant chronic plaque psoriasis
Intervention
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).
Intervention type
Drug
Phase
Not Applicable
Drug names
Indigo naturalis ointment
Primary outcome measure
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).
Secondary outcome measures
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.
Overall trial start date
01/05/2004
Overall trial end date
30/04/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
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
Recruitment start date
01/05/2004
Recruitment end date
30/04/2005
Locations
Countries of recruitment
Taiwan
Trial participating centre
123 Ding-Hu road
Taoyuan
333
Taiwan
Sponsor information
Organisation
Chang Gung Memorial Hospital (Taiwan)
Sponsor details
123 Ding-Hu road
Kuei-Shan
Taoyuan
333
Taiwan
lin1266@adm.cgmh.org.tw
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Chang Gung Memorial Hospital (Taiwan) (ref: CMRPG 33024)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19015420
Publication citations
-
Results
Lin YK, Chang CJ, Chang YC, Wong WR, Chang SC, Pang JH, Clinical assessment of patients with recalcitrant psoriasis in a randomized, observer-blind, vehicle-controlled trial using indigo naturalis., Arch Dermatol, 2008, 144, 11, 1457-1464, doi: 10.1001/archderm.144.11.1457.