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

Launched by JOHNSON & JOHNSON CONSUMER PRODUCTS COMPANY DIVISION OF JOHNSON & JOHNSON CONSUMER COMPANIES, INC. · Dec 1, 2011

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

• 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.