Botulinum Toxin A for Herpes Labialis

Not Applicable

Terminated

Conditions: Herpes Labialis

Interventions: Drug: onabotulinumtoxinA
Other: Bacteriostatic normal saline

Registration Number: NCT01225341

Lead Sponsor: DeNova Research

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 20

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
onabotulinumtoxinA/placebo	Bacteriostatic normal saline	Patients will be injected every 3 months with onabotulinumtoxinA for a period of 12 months. At the 12 month visit, patients will receive injections of saline.
Bacteriostatic normal saline/ onabotulnimtoxinA	Bacteriostatic normal saline	Patients will be injected every 3 months with saline for a period of 12 months. At the 12 month visit, patients will receive injections of onabotulnimtoxinA.
onabotulinumtoxinA/placebo	onabotulinumtoxinA	Patients will be injected every 3 months with onabotulinumtoxinA for a period of 12 months. At the 12 month visit, patients will receive injections of saline.
Bacteriostatic normal saline/ onabotulnimtoxinA	onabotulinumtoxinA	Patients will be injected every 3 months with saline for a period of 12 months. At the 12 month visit, patients will receive injections of onabotulnimtoxinA.

Primary Outcome Measures

Name	Time	Method
Measurement of Recurrence and Duration of Herpes Labialis Lesions	12 months	Days between last injection and outbreak onset \& Days between onset and recurrence

Secondary Outcome Measures

Name	Time	Method
Measurement of Lesion Size	12 months	Lesions will be measured in millimeters across the maximal lesion length in mm
Pain Assessment	During outbreak	Each day of a recurrence of herpes labialis, the subject will document his/her pain level in the diary according to the Visual Analog Scale for pain (VAS) by placing a straight line intersecting the pain line. The scale will be 10 cm long and the distance from start to mark will be measured in millimeters. Score range is 0-10. Scores closer to 0 signify lower pain levels and scores closer to 10 signify high pain levels
Symptom Evaluation	During outbreak	Each day of a recurrence of herpes labialis, the subject will document his/her pain level in the diary according to a 4-point scale ((0) none, (1) mild, (2) moderate, (3) severe). Scores closer to 0 indicate a more favorable outcome.