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

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ClinicalTrials.gov Identifier: NCT01971385
Recruitment Status : Completed
First Posted : October 29, 2013
Results First Posted : October 2, 2017
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Herpes Labialis
Interventions Drug: Squaric Acid solution
Drug: Placebo solution
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 0.2% Squaric Acid 0.5% Squaric Acid Placebo Solution
Hide Arm/Group Description

0.2% Squaric Acid solution disolved in dimethyl sulfoxide will be applied

Squaric Acid solution

0.5% Squaric Acid solution disolved in dimethyl sulfoxide will be applied

Squaric Acid solution

Patients in placebo group will be given dimethyl sulfoxide.

Placebo solution

Period Title: Overall Study
Started 17 18 19
Completed 14 13 15
Not Completed 3 5 4
Arm/Group Title 0.2% Squaric Acid 0.5% Squaric Acid Placebo Solution Total
Hide Arm/Group Description

0.2% Squaric Acid solution disolved in dimethyl sulfoxide will be applied

Squaric Acid solution

0.5% Squaric Acid solution disolved in dimethyl sulfoxide will be applied

Squaric Acid solution

Patients in placebo group will be given dimethyl sulfoxide.

Placebo solution

Total of all reporting groups
Overall Number of Baseline Participants 17 18 19 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 18 participants 19 participants 54 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
  88.2%
18
 100.0%
19
 100.0%
52
  96.3%
>=65 years
2
  11.8%
0
   0.0%
0
   0.0%
2
   3.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 18 participants 19 participants 54 participants
44.86  (13.68) 47.21  (9.37) 44.13  (10.88) 44.93  (11.88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 18 participants 19 participants 54 participants
Female
14
  82.4%
13
  72.2%
13
  68.4%
40
  74.1%
Male
3
  17.6%
5
  27.8%
6
  31.6%
14
  25.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 18 participants 19 participants 54 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  17.6%
0
   0.0%
0
   0.0%
3
   5.6%
White
13
  76.5%
17
  94.4%
18
  94.7%
48
  88.9%
More than one race
1
   5.9%
0
   0.0%
0
   0.0%
1
   1.9%
Unknown or Not Reported
0
   0.0%
1
   5.6%
1
   5.3%
2
   3.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 18 participants 19 participants 54 participants
17 18 19 54
Number of Outbreaks a year  
Mean (Standard Deviation)
Unit of measure:  Frequency per year
Number Analyzed 17 participants 18 participants 19 participants 54 participants
7.06  (1.71) 7.81  (1.81) 8.14  (2.42) 7.68  (2.02)
1.Primary Outcome
Title Subjects With at Least One Form of Contact With Study Staff With no Herpes Labialis Outbreaks Within 119 Days of Sensitization
Hide Description 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
Time Frame 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
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%.
Arm/Group Title 2% Squaric Acid Sensitization Placebo Solution
Hide Arm/Group Description:

2% Squaric Acid solution will be applied for sensitization to the inner arm.

Squaric Acid solution

Patients in placebo group will be given dimethyl sulfoxide.

Placebo solution

Overall Number of Participants Analyzed 27 15
Measure Type: Number
Unit of Measure: percentage of particpants
62.96 20
2.Secondary Outcome
Title Number of Adverse Events Reported
Hide Description To assess the safety and tolerability of squaric acid solution the number of adverse events in each treatment arm will be collected and compared.
Time Frame 8 months
Outcome Measure Data Not Reported
Time Frame 8 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 0.2% Squaric Acid 0.5% Squaric Acid Placebo Solution
Hide Arm/Group Description

0.2% Squaric Acid solution disolved in dimethyl sulfoxide will be applied

Squaric Acid solution

0.5% Squaric Acid solution disolved in dimethyl sulfoxide will be applied

Squaric Acid solution

Patients in placebo group will be given dimethyl sulfoxide.

Placebo solution

All-Cause Mortality
0.2% Squaric Acid 0.5% Squaric Acid Placebo Solution
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
0.2% Squaric Acid 0.5% Squaric Acid Placebo Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/18 (0.00%)      0/19 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
0.2% Squaric Acid 0.5% Squaric Acid Placebo Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/17 (52.94%)      6/18 (33.33%)      3/19 (15.79%)    
Skin and subcutaneous tissue disorders       
Non Serious Itching, Redness, or Swelling  [1]  8/17 (47.06%)  8 5/18 (27.78%)  5 2/19 (10.53%)  2
Other Non Serious AE  [2]  1/17 (5.88%)  1 1/18 (5.56%)  1 1/19 (5.26%)  1
Indicates events were collected by systematic assessment
[1]
Subjects who reported itching, redness, or swelling and were recorded as a non-serious AE
[2]
Other AEs that were reported by subjects but were non-serious
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Maria Alora-Palli
Organization: Massachusetts General Hospital
Phone: 6177265066
EMail: mpalli@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Alexandra Kimball, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01971385     History of Changes
Other Study ID Numbers: 2013P001028
First Submitted: October 17, 2013
First Posted: October 29, 2013
Results First Submitted: March 23, 2017
Results First Posted: October 2, 2017
Last Update Posted: October 2, 2017