Botulinum Toxin A for Herpes Labialis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Steven H. Dayan, DeNova Research
ClinicalTrials.gov Identifier:
NCT01225341
First received: October 19, 2010
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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 Intervention
Herpes Labialis
Drug: onabotulinumtoxinA
Other: Bacteriostatic normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by DeNova Research:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 3 months post injection ] [ Designated as safety issue: No ]

    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:
  • Measurement of Lesion Size [ Time Frame: During outbreak ] [ Designated as safety issue: No ]
    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.

  • Pain Assessment [ Time Frame: During outbreak ] [ Designated as safety issue: No ]
    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

  • Symptom Evaluation [ Time Frame: During outbreak ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 20
Study Start Date: August 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225341

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

Additional Information:
No publications provided

Responsible Party: Steven H. Dayan, Medical Director, DeNova Research
ClinicalTrials.gov Identifier: NCT01225341     History of Changes
Other Study ID Numbers: HSV-BOT-01-09
Study First Received: October 19, 2010
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014