A Double-Blind, Randomized, Placebo Controlled, Crossover Study to Assess the Safety and Efficacy of Botulinum Toxin A Injections as a Preventative Measure for Herpes Labialis.
Overview
- Phase
- N/A
- Intervention
- onabotulinumtoxinA
- Conditions
- Herpes Labialis
- Sponsor
- DeNova Research
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Measurement of Recurrence and Duration of Herpes Labialis Lesions
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
Steven H. Dayan
Medical Director
DeNova Research
Eligibility Criteria
Inclusion Criteria
- •Males or females between the ages of 18 and
- •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).
Arms & Interventions
onabotulinumtoxinA/placebo
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.
Intervention: onabotulinumtoxinA
onabotulinumtoxinA/placebo
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.
Intervention: Bacteriostatic normal saline
Bacteriostatic normal saline/ onabotulnimtoxinA
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.
Intervention: onabotulinumtoxinA
Bacteriostatic normal saline/ onabotulnimtoxinA
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.
Intervention: Bacteriostatic normal saline
Outcomes
Primary Outcomes
Measurement of Recurrence and Duration of Herpes Labialis Lesions
Time Frame: 12 months
Days between last injection and outbreak onset \& Days between onset and recurrence
Secondary Outcomes
- Measurement of Lesion Size(12 months)
- Pain Assessment(During outbreak)
- Symptom Evaluation(During outbreak)