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

Completed

• Conditions: Herpes Simplex Labialis; Skin and Connective Tissue Diseases; Herpes simplex labialis

• Registration Number: ISRCTN03397663
• Lead Sponsor: BSP Pharma A/S (Denmark)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-05
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute study: Duration of initial herpes labialis episode.<br>Maintenance study: Number of herpes labialis episodes during the 6 months of the maintenance study period.

Secondary Outcome Measures

Name	Time	Method
Acute study:<br>1. Investigator-assessment of Herpes Lesion development stage<br>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)<br>3. Quality of Life measured by Short Form-36 questionnaire and the Dermatology Life Quality Index<br><br>Maintenance study:<br>1. The number of participants who develop lesions during the 6 months of the maintenance study period<br>2. Time to first herpes episode<br>3. Duration of lesions<br>4. Use of rescue medication<br>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)<br>6. Quality of Life measured by Short Form-36 questionnaire and the Dermatology Life Quality Index