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 |
| Secondary identifying numbers | BPCS01 |
- 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
Scientific
Mater Health Services
2nd Floor, Community Health Services Bldg
39 Annerley Rd
South Brisbane
4101
Australia
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sheabutter extract |
| Primary outcome measure | 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 study start date | 01/02/2005 |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
4101
Australia
Sponsor information
BSP Pharma A/S (Denmark)
Industry
Industry
M.P Bruuns Gade 27
Aarhus
DK-8000
Denmark
"ROR" |
https://ror.org/05tzrdd39 |
|---|
Funders
Funder type
Industry
BSP Pharma A/S (Denmark) - AUD478,790
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
