Condition category
Skin and Connective Tissue Diseases
Date applied
05/05/2005
Date assigned
05/07/2005
Last edited
31/03/2010
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

Mater Health Services
2nd Floor
Community Health Services Bldg
39 Annerley Rd
South Brisbane
4101
Australia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BPCS01

Study information

Scientific title

Acronym

Study hypothesis

The hypothesis is that various concentrations of Sheabutter extract BSP110 are able to reduce the healing time of cold sores and prevent their recurrence in participants with 6 or more self reported cold sores a year.

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

Herpes Simplex Labialis

Intervention

Acute study - 100% sheabutter extract BSP 110 ointment versus placebo of yellow petrolatum.
Maintenance study - 25% sheabutter lip balm versus 25% yellow petrolatum lip balm.

Intervention type

Drug

Phase

Not Specified

Drug names

Sheabutter extract

Primary outcome measures

Acute study: Duration of initial herpes labialis episode.
Maintenance study: Number of herpes labialis episodes during the 6 months of the maintenance study period.

Secondary outcome measures

Acute study:
1. Investigator-assessment of Herpes Lesion development stage
2. Participant self-assessment of severity of symptoms including pain, tingling, itching, swelling, blistering, oozing and crusting using Likert scales (0 = none, 1 = mild, 2 = moderate, 3 = severe)
3. Quality of Life measured by Short Form-36 questionnaire and the Dermatology Life Quality Index

Maintenance study:
1. The number of participants who develop lesions during the 6 months of the maintenance study period
2. Time to first herpes episode
3. Duration of lesions
4. Use of rescue medication
5. Participant self-assessment of severity of symptoms including pain, tingling, itching, swelling, blistering, oozing and crusting using Likert scales (0 = none, 1 = mild, 2 = moderate, 3 = severe)
6. Quality of Life measured by Short Form-36 questionnaire and the Dermatology Life Quality Index

Overall trial start date

01/02/2005

Overall trial end date

31/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Subjects aged 18 and 75 years, in good general health who have a clinical history of recurrent herpes labialis, with at least six self reported episodes of herpes lesion in the past year and at least one recurrance every three months.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant exclusion criteria

1. History of immunodeficiency
2. Use of other antiviral agents (including herbal medications), anti-inflammatory medications, steroids or analgesics during the treatment period
3. Known allergy to Sheabutter
4. Liver function tests greater than 3 times the upper limit of normal at baseline
5. Female participants who are lactating, pregnant or planning to become pregnant
6. Participants who have participated in another clinical trial in the last 30 days
7. Participants unwilling to comply with the study protocol
8. Any other condition, which in the opinion of the investigators could compromise the study

Recruitment start date

01/02/2005

Recruitment end date

31/03/2006

Locations

Countries of recruitment

Australia

Trial participating centre

Mater Health Services
South Brisbane
4101
Australia

Sponsor information

Organisation

BSP Pharma A/S (Denmark)

Sponsor details

M.P Bruuns Gade 27
Aarhus
DK-8000
Denmark

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

BSP Pharma A/S (Denmark) - AUD478,790

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