Trial Outcomes & Findings for Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis (NCT NCT01971385)

NCT ID: NCT01971385

Last Updated: 2017-10-02

Results Overview

Percent of subjects with no reported herpes labialis outbreak within 119 days of sensitization over total number of subjects after one form of contact with study staff

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 54 participants
• Primary outcome timeframe: 8 months
• Results posted on: 2017-10-02

Participant Flow

Participant milestones

Measure	0.2% Squaric Acid 0.2% Squaric Acid solution disolved in dimethyl sulfoxide will be applied Squaric Acid solution	0.5% Squaric Acid 0.5% Squaric Acid solution disolved in dimethyl sulfoxide will be applied Squaric Acid solution	Placebo Solution Patients in placebo group will be given dimethyl sulfoxide. Placebo solution
Overall Study STARTED	17	18	19
Overall Study COMPLETED	14	13	15
Overall Study NOT COMPLETED	3	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis

Baseline characteristics by cohort

Measure	0.2% Squaric Acid n=17 Participants 0.2% Squaric Acid solution disolved in dimethyl sulfoxide will be applied Squaric Acid solution	0.5% Squaric Acid n=18 Participants 0.5% Squaric Acid solution disolved in dimethyl sulfoxide will be applied Squaric Acid solution	Placebo Solution n=19 Participants Patients in placebo group will be given dimethyl sulfoxide. Placebo solution	Total n=54 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	15 Participants n=5 Participants	18 Participants n=7 Participants	19 Participants n=5 Participants	52 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Age, Continuous	44.86 years STANDARD_DEVIATION 13.68 • n=5 Participants	47.21 years STANDARD_DEVIATION 9.37 • n=7 Participants	44.13 years STANDARD_DEVIATION 10.88 • n=5 Participants	44.93 years STANDARD_DEVIATION 11.88 • n=4 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	13 Participants n=7 Participants	13 Participants n=5 Participants	40 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	17 Participants n=7 Participants	18 Participants n=5 Participants	48 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	17 participants n=5 Participants	18 participants n=7 Participants	19 participants n=5 Participants	54 participants n=4 Participants
Number of Outbreaks a year	7.06 frequency per year STANDARD_DEVIATION 1.71 • n=5 Participants	7.81 frequency per year STANDARD_DEVIATION 1.81 • n=7 Participants	8.14 frequency per year STANDARD_DEVIATION 2.42 • n=5 Participants	7.68 frequency per year STANDARD_DEVIATION 2.02 • n=4 Participants

PRIMARY outcome

Timeframe: 8 months

Population: Because most patients who received 2% SADBE for sensitization did not experience another herpes outbreak and thus did not receive a subsequent treatment dose, we grouped both squaric acid treatment arms together for analysis since both groups had received the same sensitization dose of 2%.

Percent of subjects with no reported herpes labialis outbreak within 119 days of sensitization over total number of subjects after one form of contact with study staff

Outcome measures

Measure	2% Squaric Acid Sensitization n=27 Participants 2% Squaric Acid solution will be applied for sensitization to the inner arm. Squaric Acid solution	Placebo Solution n=15 Participants Patients in placebo group will be given dimethyl sulfoxide. Placebo solution
Subjects With at Least One Form of Contact With Study Staff With no Herpes Labialis Outbreaks Within 119 Days of Sensitization	62.96 percentage of particpants	20 percentage of particpants

SECONDARY outcome

Timeframe: 8 months

To assess the safety and tolerability of squaric acid solution the number of adverse events in each treatment arm will be collected and compared.

Outcome measures

Outcome data not reported

Adverse Events

0.2% Squaric Acid

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

0.5% Squaric Acid

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo Solution

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	0.2% Squaric Acid n=17 participants at risk 0.2% Squaric Acid solution disolved in dimethyl sulfoxide will be applied Squaric Acid solution	0.5% Squaric Acid n=18 participants at risk 0.5% Squaric Acid solution disolved in dimethyl sulfoxide will be applied Squaric Acid solution	Placebo Solution n=19 participants at risk Patients in placebo group will be given dimethyl sulfoxide. Placebo solution
Skin and subcutaneous tissue disorders Non Serious Itching, Redness, or Swelling	47.1% 8/17 • Number of events 8 • 8 months	27.8% 5/18 • Number of events 5 • 8 months	10.5% 2/19 • Number of events 2 • 8 months
Skin and subcutaneous tissue disorders Other Non Serious AE	5.9% 1/17 • Number of events 1 • 8 months	5.6% 1/18 • Number of events 1 • 8 months	5.3% 1/19 • Number of events 1 • 8 months

Additional Information

Dr. Maria Alora-Palli

Massachusetts General Hospital

Phone: 6177265066

Email: mpalli@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place