Study of a New Topical Natural Health Product for the Treatment of Herpes Labialis

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Topical Natural Health Product for the Treatment of Herpes Labialis

The aim of this study is to determine the safety and efficacy of a topical natural health product in comparison to placebo for the treatment of herpes labialis.

Inclusion Criteria:

• Female and male, in good health, 18 years of age or older,
• With history of recurrent herpes labialis with at least twice a year during the past twenty-four months,
• Agreeing not to take another treatment against cold sore, nor anti-inflammatory, antibiotics and steroids,
• Cooperating in the study, able to be monitored at each visit, aware of the demands and duration of the controls, thus allowing perfect adherence to the established protocol,
• Must be willing and able to participate and to provide written informed consent,
• Female subjects of childbearing potential must have a negative pregnancy test at screening and agree to use a proper contraceptive method during the study.

Exclusion Criteria:

• Volunteers who refuse to introduce the product to be tested in its routine,
• With a history of hypersensitivity to the type of product to be tested (e.g., products that contain essential oil),
• Who have a history of eczema, topical dermatitis, psoriasis or significant skin anomalies on the areas to be tested,
• Who suffer from a serious illness or health problem or a critical or progressive disease,
• Who have taken prescription or over the counter medication that could affect skin characteristics or could bias the study (i.e. antibiotics, antihistamines, anti-inflammatories…) within 7 days prior to study beginning,
• Who have recently acquired or who currently have significant skin pigmentation, who frequent tanning salons or foresee exposure to the sun during the study,
• Who abuse alcohol, drugs and/or tobacco,
• Female subjects who are pregnant, breastfeeding or expecting to become pregnant during the study.