Randomised placebo controlled trial on the safety and efficacy of a topical treatment for bilaternal chronic plaque psoriasis in adults

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Phillip Cheras
Scientific

39 Annerley Rd
South Brisbane
Brisbane
4101
Australia

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	H BioJuven SBS1 Herbal Skin Balm is able to reduce the severity of chronic plaque psoriasis in adults.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Mild to moderate bilaternal chronic plaque psoriasis
Intervention	H BioJuven SBS1 Herbal Skin Balm versus an indentical placebo skin balm.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	H BioJuven SBS1 Herbal Skin Balm
Primary outcome measure(s)	The change in erythema, scaling and induration (ESI) scores from beginning to end of treatment. Erythema (redness), scaling and induration (thickening), is scored on a 0 to 3 scale (0 = none and 3 = severe) and sum of these scores for each target lesion is the ESI score.
Key secondary outcome measure(s)	1. Quality of life will be measured using the Dermatology Life Quality Index (DLQI) 2. Investigator and patient ratings of the efficacy of the treatment which measured on a 6 point scale: worse; unchanged; slight improvement (25%); moderate improvement (50%); marked improvement (75%); or clearance
Completion date	20/12/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	29
Key inclusion criteria	1. Participants with mild to moderate, bilateral symmetric, chronic plaque type psoriasis 2. In good general health and adequate venous access 3. Participants of childbearing age who agree to continue using birth control measures for the duration of the study 4. 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 generalized 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. UV light therapy within 21 days of baseline 6. Topical corticosteroids within 14 days of baseline 7. Liver function tests greater than 3 times the upper limit of normal at baseline 8. Female participants who are lactating, pregnant or planning to become pregnant 9. Participants have participated in another clinical trial in the last 30 days 10. Participants unwilling to comply with study protocol 11. Any other condition, which in the opinion of the investigators could compromise the study
Date of first enrolment	27/06/2005
Date of final enrolment	20/12/2005

39 Annerley Rd

Brisbane
4101
Australia

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan