Botulinum Toxin A for Herpes Labialis

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.