Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.cgmh.org.tw

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

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19015420

Publication citations

  1. 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.

Editorial Notes