Condition category
Skin and Connective Tissue Diseases
Date applied
16/06/2005
Date assigned
21/09/2005
Last edited
14/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Phillip Cheras

ORCID ID

Contact details

39 Annerley Rd
South Brisbane
Brisbane
4101
Australia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BJPS01

Study information

Scientific title

Acronym

Study hypothesis

H BioJuven SBS1 Herbal Skin Balm is able to reduce the severity of chronic plaque psoriasis in adults.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

H BioJuven SBS1 Herbal Skin Balm

Primary outcome measures

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.

Secondary outcome measures

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

Overall trial start date

27/06/2005

Overall trial end date

20/12/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

29

Participant 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

Recruitment start date

27/06/2005

Recruitment end date

20/12/2005

Locations

Countries of recruitment

Australia

Trial participating centre

39 Annerley Rd
Brisbane
4101
Australia

Sponsor information

Organisation

H BioJuven Pty Ltd (Australia)

Sponsor details

36-38 Gipps St
Collingwood
Melbourne
3066
Australia

Sponsor type

Industry

Website

http://www.swisse.com.au

Funders

Funder type

Industry

Funder name

H BioJuven Pty Ltd (Australia)

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

Publication citations

Additional files

Editorial Notes