Botulinum Toxin A for Herpes Labialis

NCT01225341 | Terminated Results

• 1 other identifier: HSV-BOT-01-09
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Measurement of Recurrence and Duration of Herpes Labialis Lesions

  Days between last injection and outbreak onset \& Days between onset and recurrence

  12 months

Secondary Outcomes (3)

• Measurement of Lesion Size

  12 months

• Pain Assessment

  During outbreak

• Symptom Evaluation

  During outbreak

Study Arms (2)

onabotulinumtoxinA/placebo

EXPERIMENTAL

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; Other: Bacteriostatic normal saline

Bacteriostatic normal saline/ onabotulnimtoxinA

PLACEBO COMPARATOR

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; Other: Bacteriostatic normal saline

Interventions

onabotulinumtoxinA 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.

Also known as: Botox

Bacteriostatic normal saline/ onabotulnimtoxinA; onabotulinumtoxinA/placebo

Bacteriostatic normal saline 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.

Also known as: Saline

Bacteriostatic normal saline/ onabotulnimtoxinA; onabotulinumtoxinA/placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DeNova Research: lead
• Allergan: collaborator

Study Sites (1)

DeNova Research

Chicago, Illinois, 60611, United States

Location

Related Links

• DeNova Research

MeSH Terms

Conditions

Herpes Labialis

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

The study was terminated and the PI/study team no longer has access to study data as it was destroyed. Efforts were exhausted to locate any remaining data, but were unsuccessful. No study data are available to report

Results Point of Contact

• Title: Steven Dayan, MD
• Organization: DeNova Research

sdayan@drdayan.com

3123352070

Study Officials

• Steven H Dayan, MD

  DeNova Research/ Chicago Center for Facial Plastic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: October 21, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 21, 2020
• Results First Posted: December 21, 2020

Record last verified: 2020-11

Locations

US (1)