Botulinum Toxin A for Herpes Labialis

• Status: Terminated
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: DeNova Research
• Collaborator: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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.