Status:
TERMINATED
Botulinum Toxin A for Herpes Labialis
Lead Sponsor:
DeNova Research
Collaborating Sponsors:
Allergan
Conditions:
Herpes Labialis
Eligibility:
All Genders
18-64 years
Phase:
NA
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
- 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
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01225341
Start Date
August 1 2010
End Date
June 1 2012
Last Update
December 21 2020
Active Locations (1)
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1
DeNova Research
Chicago, Illinois, United States, 60611