Trial Outcomes & Findings for Botulinum Toxin A for Herpes Labialis (NCT NCT01225341)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

12 months

Results posted on

2020-12-21

Participant Flow

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

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 12 months

Population: 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

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: 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

Lesions will be measured in millimeters across the maximal lesion length in mm

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During outbreak

Population: 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

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During outbreak

Population: 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

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.

Outcome measures

Outcome data not reported

Adverse Events

onabotulinumtoxinA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bacteriostatic Normal Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven Dayan, MD

DeNova Research

Phone: 3123352070

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place