Study of a Cold Sore Patch for the Treatment of Herpes Labialis

This is a two-arm, randomized, clinician-blind study. No severe adverse effects are expected to be experienced in the control group. All subjects are allowed to treat cold sore related pain with an oral analgesic - paracetamol (APAP). The use of APAP for pain will be recorded as a concomitant medication. However, subjects will be required to refrain from using any additional treatment (topical or systemic) during study participation.

Subjects randomized to treatment will be instructed to initiate the therapy within 1 hour onset of their first sign or symptom and record their assessment in the diary card (for no treatment subjects, they will only record assessments upon onset of first sign or symptom). All subjects will return to the study center for clinical assessments within 24 hours and 48 hours after onset of first sign or symptom/initiation of treatment and every other day thereafter, with a final visit at Day 10 or at the time of completion/discontinuation if before Day 10. Diaries will be completed each day, beginning upon initiation of therapy (Day 0) and continuing until study completion/discontinuation, and will include information on study product applications.

Subjects assigned to a patch treatment will wear a patch continuously on their lesion and will apply a new patch on occasions where the patch becomes loose, falls off or becomes unsightly, including at study visits to the facility where subjects will be asked to remove their patch for clinical assessments. Treatment will continue until the lesion is healed, for a maximum of 10 days. As the test period will possibly extend through the end of year holiday break, subject visits and treatments will be halted during this break. All subjects who have not initiated therapy including subjects assigned no treatment group, will be allowed to use their regular therapy for a cold sore outbreak during the holiday break.

Inclusion criteria

• Female or male 18-70 years old in good general health
• Has a history of Herpes Labialis in the areas and with the frequency defined in the protocol.
• Based on history, likely to experience a cold sore outbreak within next 2 to 3 months
• Willing to provide informed consent
• Willing to stop all other treatment of this condition and any topical products (lip balm, cosmetics, sunscreen) during test period
• Women of child bearing potential must agree to use an adequate method of birth control (systemic birth control/intrauterine device)

Exclusion criteria

• Self-reported to be pregnant, planning to become pregnant or nursing
• Has any medical history or condition that might, per protocol or in the opinion of the investigator, compromise the subject's safety or the analysis of results.
• Is taking or has taken within the 28 days before commencing treatment, protocol-specified medications or herbal supplements.