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ISRCTN
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ISRCTN74459383
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ClinicalTrials.gov identifier
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Public title
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Randomised placebo controlled trial on the safety and efficacy of a topical treatment for bilaternal chronic plaque psoriasis in adults
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Scientific title
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Acronym
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N/A
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Serial number at source
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BJPS01
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Study hypothesis
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H BioJuven SBS1 Herbal Skin Balm is able to reduce the severity of chronic plaque psoriasis in adults.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Australia
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Disease/condition/study domain
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Mild to moderate bilaternal chronic plaque psoriasis
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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27/06/2005
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Anticipated end date
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20/12/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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29
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Interventions
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H BioJuven SBS1 Herbal Skin Balm versus an indentical placebo skin balm.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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
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Sources of funding
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H BioJuven Pty Ltd (Australia)
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Trial website
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Publications
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Contact name
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Dr
Phillip
Cheras
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Address
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39 Annerley Rd
South Brisbane
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City/town
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Brisbane
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Zip/Postcode
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4101
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Country
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Australia
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Sponsor
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H BioJuven Pty Ltd (Australia)
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Address
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36-38 Gipps St
Collingwood
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City/town
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Melbourne
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Zip/Postcode
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3066
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Country
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Australia
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Sponsor website:
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http://www.swisse.com.au
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Date applied
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16/06/2005
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Last edited
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14/09/2009
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Date ISRCTN assigned
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21/09/2005
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