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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN03397663

Enrollment

160

Registered

2005-07-05

Start date

2005-02-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Simplex Labialis Skin and Connective Tissue Diseases Herpes simplex labialis

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Primary

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

Countries

Australia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026