Botulinum Toxin A for Herpes Labialis

DeNova Research

Status: Terminated

Conditions: Herpes Labialis

Treatments: Drug: onabotulinumtoxinA; Other: Bacteriostatic normal saline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01225341

HSV-BOT-01-09

Details and patient eligibility

About

The purpose of this study is to determine the efficacy and safety of Botulinum Toxin Type A as a preventative measure for Herpes Labialis.

Enrollment: 20 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

onabotulinumtoxinA/placebo

Experimental group

Description:

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.

Treatment:

Other: Bacteriostatic normal saline

Drug: onabotulinumtoxinA

Bacteriostatic normal saline/ onabotulnimtoxinA

Placebo Comparator group

Description:

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.

Treatment:

Other: Bacteriostatic normal saline

Drug: onabotulinumtoxinA