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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.

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Conditions:		Herpes Labialis
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.
Study Summary:
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.
NCT ID:		NCT01225341
Primary Contact:		Principal Investigator Steven H Dayan, MD DeNova Research/ Chicago Center for Facial Plastic Surgery
Backup Contact:		N/A
Location Contact:		Chicago, Illinois 60611 United States There is no listed contact information for this specific location. Site Status: N/A

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