Clinical trial NCT01225341: Botulinum Toxin A for Herpes Labialis
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Herpes Labialis
Keywords: HSV-1
Herpes labialis
Cold sores
Fever blisters
Lead sponsor: DeNova Research
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2010-10-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Measurement of Recurrence and Duration of Herpes Labialis Lesions
timeFrame: 12 months
Secondary outcomes:
measure: Measurement of Lesion Size
timeFrame: 12 months
measure: Pain Assessment
timeFrame: During outbreak
measure: Symptom Evaluation
timeFrame: During outbreak
Other outcomes:
Locations:
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
Study officials:
affiliation: DeNova Research/ Chicago Center for Facial Plastic Surgery
name: Steven H Dayan, MD
role: PRINCIPAL_INVESTIGATOR
References: