Botulinum Toxin A for Herpes Labialis

Overview

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

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2012

Interventions

  • Drug: onabotulinumtoxinA
    • Botox┬« is supplied in a 100 U vial and will be reconstituted with 3.3 mL of 0.9% Sodium Chloride Injection USP to yield a solution of 3 U per 0.1 mL. Study treatment will consist of an injection of Botox┬« (onabotulinumtoxinA) (3 U/ 0.1 mL) into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle.
  • Other: Bacteriostatic normal saline
    • Study treatment will consist of an injection of bacteriostatic normal saline, into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle.

Arms, Groups and Cohorts

  • Experimental: 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.
  • Placebo Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Measurement of Lesion Size
    • Time Frame: 12 months
    • Lesions will be measured in millimeters across the maximal lesion length in mm
  • Pain Assessment
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • DeNova Research
  • Collaborator
    • Allergan
  • Provider of Information About this Clinical Study
    • Principal Investigator: Steven H. Dayan, Medical Director – DeNova Research
  • Overall Official(s)
    • Steven H Dayan, MD, Principal Investigator, DeNova Research/ Chicago Center for Facial Plastic Surgery

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