Trial Outcomes & Findings for Double-blind, Vehicle-controlled Study of the Efficacy and Safety of SADBE in Subjects With Recurrent Herpes Labialis (NCT NCT02965781)

Last Updated: 2021-11-02

Results Overview

The number of days until a patient reports his or her first new herpes labialis episode from 43 - 121 days following the first dose

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

139 participants

Primary outcome timeframe

43 - 121 days after the first dose

Results posted on

2021-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	One SADBE Application Patient will receive a topical 2% SADBE sensitization dose applied to the patient's upper arm. Three weeks after topical sensitization dose patient will receive topical placebo applied to the patient's upper arm. SADBE: Topical solution Placebo: Topical solution	Two SADBE Applications Patient will receive a topical 2% SADBE sensitization dose applied to the patient's upper arm. A 0.5% SADBE intensification dose will be applied to the patient's upper arm 3 weeks after sensitization dose. SADBE: Topical solution	Placebo Application (DMSO Only-No SADBE) Patient will receive a topical placebo (vehicle-DMSO) dose applied to the patient's upper arm. A topical placebo (vehicle-DMSO) follow up dose will be applied to the patient's upper arm 3 weeks after the first placebo dose dose. Placebo: Topical solution
Overall Study STARTED	46	46	47
Overall Study COMPLETED	46	46	47
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Double-blind, Vehicle-controlled Study of the Efficacy and Safety of SADBE in Subjects With Recurrent Herpes Labialis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	One SADBE Application n=46 Participants Patient will receive a topical 2% SADBE sensitization dose applied to the patient's upper arm. Three weeks after topical sensitization dose patient will receive topical placebo applied to the patient's upper arm. SADBE: Topical solution Placebo: Topical solution	Two SADBE Applications n=46 Participants Patient will receive a topical 2% SADBE sensitization dose applied to the patient's upper arm. A 0.5% SADBE intensification dose will be applied to the patient's upper arm 3 weeks after sensitization dose. SADBE: Topical solution	Placebo Application (DMSO Only-No SADBE) n=47 Participants Patient will receive a topical placebo (vehicle-DMSO) dose applied to the patient's upper arm. A topical placebo (vehicle-DMSO) follow up dose will be applied to the patient's upper arm 3 weeks after the first placebo dose dose. Placebo: Topical solution	Total n=139 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=5 Participants	46 Participants n=7 Participants	47 Participants n=5 Participants	139 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	47.8 years n=5 Participants	44.2 years n=7 Participants	50.1 years n=5 Participants	47.1 years n=4 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	28 Participants n=7 Participants	26 Participants n=5 Participants	85 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	18 Participants n=7 Participants	21 Participants n=5 Participants	54 Participants n=4 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Black	11 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	26 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	13 Participants n=5 Participants	18 Participants n=7 Participants	17 Participants n=5 Participants	48 Participants n=4 Participants
Race/Ethnicity, Customized White	21 Participants n=5 Participants	18 Participants n=7 Participants	21 Participants n=5 Participants	60 Participants n=4 Participants
Race/Ethnicity, Customized Unasnswered	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	46 participants n=5 Participants	46 participants n=7 Participants	47 participants n=5 Participants	139 participants n=4 Participants
HSV-1-neg / HSV-2 neg	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
HSV-1-neg / HSV-2 pos	1 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants
HSV-1-pos / HSV-2 neg	30 Participants n=5 Participants	19 Participants n=7 Participants	24 Participants n=5 Participants	73 Participants n=4 Participants
HSV-1-pos / HSV-2 pos	14 Participants n=5 Participants	22 Participants n=7 Participants	13 Participants n=5 Participants	49 Participants n=4 Participants
Median self-reported prior outbreaks over 12 months	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	18 Participants n=4 Participants
4 or 5 prior outbreaks	19 Participants n=5 Participants	15 Participants n=7 Participants	21 Participants n=5 Participants	55 Participants n=4 Participants
6 or more prior outbreaks	27 Participants n=5 Participants	31 Participants n=7 Participants	25 Participants n=5 Participants	83 Participants n=4 Participants

PRIMARY outcome

Timeframe: 43 - 121 days after the first dose

The number of days until a patient reports his or her first new herpes labialis episode from 43 - 121 days following the first dose

Outcome measures

Outcome measures
Measure	Placebo Application (DMSO Only-No SADBE) n=43 Participants Placebo	Two SADBE Applications n=44 Participants 2-dose	One SADBE Application n=41 Participants 1-dose
Days to Next Herpes Labialis (Cold Sore) Episode From 43 Days After the First Dose up to 121 Days After the First Dose	128 days Interval 4.0 to 318.0	163 days Interval 7.0 to 318.0	174 days Interval 17.0 to 318.0

SECONDARY outcome

Timeframe: From day 43 after the first dose up to 12 months

The number of new herpes labialis episodes per subject during the 12-month follow up period following the first drug dose, beginning day 43 after the first dose

Outcome measures

Outcome measures
Measure	Placebo Application (DMSO Only-No SADBE) n=43 Participants Placebo	Two SADBE Applications n=44 Participants 2-dose	One SADBE Application n=41 Participants 1-dose
Number of Outbreaks Beginning 43 Days After the First Dose up to 12 Months	0.610 outbreaks per participant Standard Deviation 0.802	0.500 outbreaks per participant Standard Deviation 0.849	0.231 outbreaks per participant Standard Deviation 0.427

Adverse Events

Placebo Application (DMSO Only-No SADBE)

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Two SADBE Applications

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

One SADBE Application

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Hugh McTavish

Squarex LLC

Phone: 6512078270

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Placebo Application (DMSO Only-No SADBE) n=47 participants at risk Placebo	Two SADBE Applications n=46 participants at risk 2-dose	One SADBE Application n=46 participants at risk 1-dose
Skin and subcutaneous tissue disorders Dead skin at application site	0.00% 0/47 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	0.00% 0/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	2.2% 1/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.
Skin and subcutaneous tissue disorders Dermatitis at application site	0.00% 0/47 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	2.2% 1/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	2.2% 1/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.
Skin and subcutaneous tissue disorders Erythema, stain, or rash at application site	8.5% 4/47 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	15.2% 7/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	13.0% 6/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.
Skin and subcutaneous tissue disorders Erythema distal from application site	0.00% 0/47 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	2.2% 1/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	0.00% 0/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.
Skin and subcutaneous tissue disorders Flushed burning sensation on face	0.00% 0/47 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	2.2% 1/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	4.3% 2/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.
Skin and subcutaneous tissue disorders Herpes lesion on genitals, anus, or spine	2.1% 1/47 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	2.2% 1/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	2.2% 1/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.
Skin and subcutaneous tissue disorders Irritation, itching at application site	2.1% 1/47 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	6.5% 3/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	8.7% 4/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.
Skin and subcutaneous tissue disorders Irritation, itching distal from application site	0.00% 0/47 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	2.2% 1/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	2.2% 1/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.
Skin and subcutaneous tissue disorders Lightheadedness	2.1% 1/47 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	0.00% 0/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	0.00% 0/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.
Skin and subcutaneous tissue disorders Pimple	0.00% 0/47 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	2.2% 1/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	0.00% 0/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.
Skin and subcutaneous tissue disorders Purpura at application site	0.00% 0/47 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	0.00% 0/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	2.2% 1/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.
Skin and subcutaneous tissue disorders Papule on lip	0.00% 0/47 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	2.2% 1/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	0.00% 0/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.
Skin and subcutaneous tissue disorders Dermatitis from adhesive	4.3% 2/47 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	0.00% 0/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	0.00% 0/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.
Skin and subcutaneous tissue disorders Burning at application site.	0.00% 0/47 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	0.00% 0/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	2.2% 1/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.
Skin and subcutaneous tissue disorders Tingling, stinging at application site	8.5% 4/47 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	0.00% 0/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	0.00% 0/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.
Skin and subcutaneous tissue disorders Tingling distal from application site	6.4% 3/47 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	2.2% 1/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	0.00% 0/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.
Blood and lymphatic system disorders Anemia	2.1% 1/47 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	0.00% 0/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	0.00% 0/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.
Skin and subcutaneous tissue disorders Boil at application site	0.00% 0/47 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	2.2% 1/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.	2.2% 1/46 • 1 Year Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates. The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.