Botulinum Toxin A for Herpes Labialis
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ClinicalTrials.gov Identifier: NCT01225341 |
Recruitment Status :
Terminated
(Too many patients withdrew/lost to follow up)
First Posted : October 21, 2010
Results First Posted : December 21, 2020
Last Update Posted : December 21, 2020
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Condition or disease | Intervention/treatment | Phase |
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Herpes Labialis | Drug: onabotulinumtoxinA Other: Bacteriostatic normal saline | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
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. |
Actual Study Start Date : | August 2010 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: 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.
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Drug: 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.
Other Name: Botox Other: 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.
Other Name: Saline |
Placebo Comparator: 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.
|
Drug: 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.
Other Name: Botox Other: 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.
Other Name: Saline |
- Measurement of Recurrence and Duration of Herpes Labialis Lesions [ Time Frame: 12 months ]Days between last injection and outbreak onset & Days between onset and recurrence
- Measurement of Lesion Size [ Time Frame: 12 months ]Lesions will be measured in millimeters across the maximal lesion length in mm
- Pain Assessment [ Time Frame: During outbreak ]
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
- Symptom Evaluation [ Time Frame: During outbreak ]
Each day of a recurrence of herpes labialis, the subject will document his/her pain level in the diary according to a 4-point scale ((0) none, (1) mild, (2) moderate, (3) severe).
Scores closer to 0 indicate a more favorable outcome.

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225341
United States, Illinois | |
DeNova Research | |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | Steven H Dayan, MD | DeNova Research/ Chicago Center for Facial Plastic Surgery |
Responsible Party: | Steven H. Dayan, Medical Director, DeNova Research |
ClinicalTrials.gov Identifier: | NCT01225341 |
Other Study ID Numbers: |
HSV-BOT-01-09 |
First Posted: | October 21, 2010 Key Record Dates |
Results First Posted: | December 21, 2020 |
Last Update Posted: | December 21, 2020 |
Last Verified: | November 2020 |
HSV-1 Herpes labialis Cold sores Fever blisters |
Herpes Labialis Herpes Simplex Herpesviridae Infections DNA Virus Infections Virus Diseases Skin Diseases, Viral Lip Diseases Mouth Diseases Stomatognathic Diseases Skin Diseases, Infectious Skin Diseases |
Botulinum Toxins, Type A abobotulinumtoxinA Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents |