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
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Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital
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Study Type | Interventional |
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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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | 0.2% Squaric Acid | 0.5% Squaric Acid | Placebo Solution |
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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 |
Baseline Characteristics
Arm/Group Title | 0.2% Squaric Acid | 0.5% Squaric Acid | Placebo Solution | Total | |
---|---|---|---|---|---|
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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 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 17 participants | 18 participants | 19 participants | 54 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
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Between 18 and 65 years |
15 88.2%
|
18 100.0%
|
19 100.0%
|
52 96.3%
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>=65 years |
2 11.8%
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0 0.0%
|
0 0.0%
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2 3.7%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 17 participants | 18 participants | 19 participants | 54 participants | |
Female |
14 82.4%
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13 72.2%
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13 68.4%
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40 74.1%
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Male |
3 17.6%
|
5 27.8%
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6 31.6%
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14 25.9%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 17 participants | 18 participants | 19 participants | 54 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
|
0 0.0%
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0 0.0%
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Asian |
0 0.0%
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0 0.0%
|
0 0.0%
|
0 0.0%
|
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
|
0 0.0%
|
0 0.0%
|
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Black or African American |
3 17.6%
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0 0.0%
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0 0.0%
|
3 5.6%
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White |
13 76.5%
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17 94.4%
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18 94.7%
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48 88.9%
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More than one race |
1 5.9%
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0 0.0%
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0 0.0%
|
1 1.9%
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Unknown or Not Reported |
0 0.0%
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1 5.6%
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1 5.3%
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2 3.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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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 |
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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) |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr. Maria Alora-Palli |
Organization: | Massachusetts General Hospital |
Phone: | 6177265066 |
EMail: | mpalli@mgh.harvard.edu |
Responsible Party: | Alexandra Kimball, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01971385 |
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 |