Botulinum Toxin A for Herpes Labialis

NCT ID: NCT01225341

Last Updated: 2020-12-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-06-30

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.

Conditions

Herpes Labialis

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

onabotulinumtoxinA

Intervention Type: DRUG

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.

Bacteriostatic normal saline

Intervention Type: OTHER

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.

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.

Group Type: PLACEBO_COMPARATOR

onabotulinumtoxinA

Intervention Type: DRUG

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.

Bacteriostatic normal saline

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Botox; Saline

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

DeNova Research

OTHER

Sponsor Role: lead

Responsible Party

Steven H. Dayan

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven H Dayan, MD

Role: PRINCIPAL_INVESTIGATOR

DeNova Research/ Chicago Center for Facial Plastic Surgery

Locations

DeNova Research

Chicago, Illinois, United States

Countries

United States

Related Links

http://www.denovaresearch.com

DeNova Research

Other Identifiers

HSV-BOT-01-09

Identifier Type: -

Identifier Source: org_study_id