Botulinum Toxin A for Herpes Labialis (NCT01225341) | Clinical Trial Compass
TerminatedNot Applicable
Botulinum Toxin A for Herpes Labialis
Stopped: Too many patients withdrew/lost to follow up
United States20 participantsStarted 2010-08
Plain-language summary
The purpose of this study is to determine the efficacy and safety of Botulinum Toxin Type A as a preventative measure for Herpes Labialis.
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion Criteria:
* Males or females between the ages of 18 and 64.
* Have herpes simplex virus 1 (HSV-1) with between 2-6 herpes labialis recurrences per year.
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
* Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following is documented on the medical history:
* postmenopausal for at least 12 months prior to study drug administration
* without a uterus and/or both ovaries
* has had a bilateral tubal ligation for at least 6 months prior to study drug administration.
* absence of an other physical condition according to the PI's discretion
* Willingness and ability to provide written photo consent and adherence to photography procedures (i.e., removal of jewelry and makeup).
* Willingness and ability to provide written informed consent prior to performance of any study related procedure.
Exclusion Criteria:
* Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control.
* Subjects with a known allergy or sensitivity to any component of the…
What they're measuring
1
Measurement of Recurrence and Duration of Herpes Labialis Lesions