botulinum toxin a for herpes labialis

Conditions: Herpes Labialis

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.


Eligibility criteria:
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 study medications or anesthesia. * active recurrence of herpes labialis. * botulinum toxin to the lower 1/3 of the face with the past 6 months. * significant concurrent illness such as diabetes, epilepsy, lupus, or congestive heart failure. * concurrent skin condition affecting area to be treated. * prior surgery on the area to be treated within 3 months of initial treatment or during the study. * history or evidence of keloids or hypertrophic scarring. * current use of antivirals for the treatment of herpes labialis within 2 weeks prior to initiation of treatment (e.g., acyclovir, valaciclovir, famciclovir, and penciclovir). * topical use of over-the-counter medications for the treatment or prevention of hsv-1 (e.g., abreva). * subjects currently using aminoglycoside antibiotics, curare-like agents or other agents that might interfere with neuromuscular function. * subjects with a diagnosis of myasthenia gravis, eaton-lambert syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function or current facial palsy. * current history of chronic drug or alcohol abuse. * concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication. * subjects who, in the investigator's opinion, have a history of poor cooperation, non-compliance with medical treatment or unreliability. * enrollment in any active study involving the use of investigational devices or drugs.

Keywords: hsv-1 herpes labialis cold sores fever blisters