Status:
COMPLETED
Study of a Cold Sore Patch for the Treatment of Herpes Labialis
Lead Sponsor:
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
Conditions:
Herpes Labialis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
If a person qualifies to participate in this study, they will have an equal chance of being assigned to either of two groups. One group will receive a patch that they will need to carry with them, bec...
Detailed Description
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 or...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
472 Patients enrolled
Trial Details
Trial ID
NCT01484067
Start Date
November 1 2011
End Date
March 1 2012
Last Update
October 1 2012
Active Locations (1)
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1
Intertek CRS
Manchester, United Kingdom, M15 6SE