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 design	Randomised, double-blind, placebo-controlled, intra-patient comparison
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	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(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) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	01/05/2004
Completion date	30/04/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	Both
Target number of participants	40
Key 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
Key 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
Date of first enrolment	01/05/2004
Date of final enrolment	30/04/2005

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"	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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not 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