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
|Condition or disease||Intervention/treatment||Phase|
|Herpes Labialis||Drug: Squaric Acid solution Drug: Placebo solution||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Clinical Trial to Test the Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Active Comparator: 2% Squaric Acid Sensitization
2% Squaric Acid solution will be applied for sensitization to the inner arm.
Drug: Squaric Acid solution
Placebo Comparator: Placebo Solution
Patients in placebo group will be given dimethyl sulfoxide.
Drug: Placebo solution
- Subjects With at Least One Form of Contact With Study Staff With no Herpes Labialis Outbreaks Within 119 Days of Sensitization [ Time Frame: 8 months ]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
- Number of Adverse Events Reported [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971385
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Alexandra B Kimball, MD||Massachusetts General Hospital|