Evaluation of the efficacy and safety of a Sheabutter extract on cold sores (herpes simplex labialis)

ISRCTN	ISRCTN03397663
DOI	https://doi.org/10.1186/ISRCTN03397663
Protocol serial number	BPCS01
Sponsor	BSP Pharma A/S (Denmark)
Funder	BSP Pharma A/S (Denmark) - AUD478,790

Submission date: 05/05/2005
Registration date: 05/07/2005
Last edited: 31/03/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

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

Contact information

Dr Phillip Cheras
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Sheabutter extract
Primary outcome measure(s)	Acute study: Duration of initial herpes labialis episode. Maintenance study: Number of herpes labialis episodes during the 6 months of the maintenance study period.
Key secondary outcome measure(s)	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
Completion date	31/03/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	160
Key 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.
Key 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
Date of first enrolment	01/02/2005
Date of final enrolment	31/03/2006

Locations

Countries of recruitment

Australia

Study participating centre

Mater Health Services

South Brisbane
4101
Australia

Results and Publications

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