Botulinum Toxin A for Herpes Labialis

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Herpes Labialis	Drug: onabotulinumtoxinA; Other: Bacteriostatic normal saline	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	20 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Prevention
Official Title:	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 Start Date :	August 2010
Actual Primary Completion Date :	May 2014
Actual Study Completion Date :	June 2014

Arms and Interventions

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Arm	Intervention/treatment
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.	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 Name: Botox 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.; Other Name: 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.	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 Name: Botox 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.; Other Name: Saline

Outcome Measures

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Primary Outcome Measures :

1. Efficacy [ Time Frame: 3 months post injection ]

   Efficacy is the primary response variable for this study and therefore will be evaluated at each visit from facial injection through 24-months post baseline injection visit as described below:

   • Measurement of recurrence and duration of herpes labialis lesions
   • Onset and stop dates for recurrent episodes of herpes labialis will be recorded and transcripted from the information recorded on the subject's diary and collected at each scheduled visit.

Secondary Outcome Measures :

1. Measurement of Lesion Size [ Time Frame: During outbreak ]
   Upon recurrence of herpes labialis subject will return to site for measurement of lesion(s). Lesion will be measured in millimeters across the maximal lesion length.
2. 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
3. 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 (none, mild, moderate, severe).

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 64 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Illinois
DeNova Research
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

DeNova Research

Allergan

Investigators

Principal Investigator:	Steven H Dayan, MD	DeNova Research/ Chicago Center for Facial Plastic Surgery

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

DeNova Research 

Responsible Party:	Steven H. Dayan, Medical Director, DeNova Research
ClinicalTrials.gov Identifier:	NCT01225341 History of Changes
Other Study ID Numbers:	HSV-BOT-01-09
First Posted:	October 21, 2010
Last Update Posted:	February 12, 2015
Last Verified:	February 2015

Keywords provided by Steven H. Dayan, DeNova Research:

HSV-1; Herpes labialis; Cold sores; Fever blisters

Additional relevant MeSH terms:

Herpes Labialis; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Skin Diseases, Viral; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Skin Diseases, Infectious; Skin Diseases; Botulinum Toxins	Botulinum Toxins, Type A; onabotulinumtoxinA; abobotulinumtoxinA; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Neuromuscular Agents; Peripheral Nervous System Agents