Randomised, observer-blinded, vehicle-controlled trial on the efficacy and safety of a topical indigo naturalis ointment treatment for recalcitrant psoriasis vulgaris

ISRCTN ISRCTN77412040
DOI https://doi.org/10.1186/ISRCTN77412040
Secondary identifying numbers CMRPG 33024
Submission date
01/01/2006
Registration date
01/03/2006
Last edited
08/09/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Yin-ku Lin
Scientific

123 Ding-Hu road
Kuei-Shan
Taoyuan
333
Taiwan

Email lin1266@adm.cgmh.org.tw

Study information

Study designRandomised, double-blind, placebo-controlled, intra-patient comparison
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesThe 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(s)This study protocol was approved by the Institutional Review Board of the Chang Gung Memorial Hospital (ref: CGMH IRB No. 93- 129B).
Health condition(s) or problem(s) studiedRecalcitrant chronic plaque psoriasis
InterventionForty 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Indigo naturalis ointment
Primary outcome measureClinical 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 measuresInvestigators 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 study start date01/05/2004
Completion date30/04/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit75 Years
SexBoth
Target number of participants40
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/05/2004
Date of final enrolment30/04/2005

Locations

Countries of recruitment

  • Taiwan

Study participating centre

123 Ding-Hu road
Taoyuan
333
Taiwan

Sponsor information

Chang Gung Memorial Hospital (Taiwan)
Hospital/treatment centre

123 Ding-Hu road
Kuei-Shan
Taoyuan
333
Taiwan

Email lin1266@adm.cgmh.org.tw
Website http://www.cgmh.org.tw
ROR logo "ROR" https://ror.org/02verss31

Funders

Funder type

Hospital/treatment centre

Chang Gung Memorial Hospital (Taiwan) (ref: CMRPG 33024)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2008 Yes No