Botulinum Toxin A for Herpes Labialis | NCT01225341

NCT01225341

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Allergan	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Measurement of Lesion Size	Lesions will be measured in millimeters across the maximal lesion length in mm	12 months
Pain Assessment	Each day of a recurrence of herpes labialis, the subject will document his/her pain level in the diary according to the Visual Analog Scale for pain (VAS) by placing a straight line intersecting the pain line. The scale will be 10 cm long and the distance from start to mark will be measured in millimeters. Score range is 0-10. Scores closer to 0 signify lower pain levels and scores closer to 10 signify high pain levels

Eligibility Module

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.

Name	Affiliation	Role
Steven H Dayan, MD	DeNova Research/ Chicago Center for Facial Plastic Surgery	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
DeNova Research		Chicago	Illinois	60611	United States

Label	URL
DeNova Research	View source

Arm/Group Information

ID	Title	Description
FG000	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. 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. 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.
FG001	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. 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. 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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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. 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. 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.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical		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

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Measurement of Recurrence and Duration of Herpes Labialis Lesions

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

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

Posted

12 months

ID	Title	Description
OG000	OnabotulinumtoxinA	Patients will be injected every 3 months with onabotulinumtoxinA for a period of 12 months. 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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	onabotulinumtoxinA	Patients will be injected every 3 months with onabotulinumtoxinA for a period of 12 months. 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.

ID	Term
D006561	Herpes Simplex
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases

ID	Term
D019274	Botulinum Toxins, Type A
D012965	Sodium Chloride

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases