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 |
| Protocol serial number | CMRPG 33024 |
| Sponsor | Chang Gung Memorial Hospital (Taiwan) |
| Funder | Chang Gung Memorial Hospital (Taiwan) (ref: 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
Scientific
123 Ding-Hu road
Kuei-Shan
Taoyuan
333
Taiwan
| lin1266@adm.cgmh.org.tw |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double-blind, placebo-controlled, intra-patient comparison |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Indigo naturalis ointment |
| Primary outcome measure(s) |
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). |
| Key secondary outcome measure(s) |
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. |
| Completion date | 30/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 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
333
Taiwan
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
