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
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