Trial · NCT01971385
Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis
NCT01971385, Phase 1, Completed, Massachusetts General Hospital; results first posted 2017-10-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis. Trials, record NCT01971385. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01971385
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis
- NCT number
- NCT01971385
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 54 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Herpes Labialis
- Interventions
- Squaric Acid solution, Placebo solution
- First posted
- 2013-10-29
- Last updated
- 2017-10-02
- Results first posted
- 2017-10-02
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Subjects With at Least One Form of Contact With Study Staff With no Herpes Labialis Outbreaks Within 119 Days of Sensitization | 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 |
| Secondary | Number of Adverse Events Reported | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Subjects With at Least One Form of Contact With Study Staff With no Herpes Labialis Outbreaks Within 119 Days of Sensitization | 8 months | 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%. | percentage of particpants | NUMBER |
| SECONDARY | Number of Adverse Events Reported | 8 months |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Subjects With at Least One Form of Contact With Study Staff With no Herpes Labialis Outbreaks Within 119 Days of Sensitization | 2% Squaric Acid Sensitization | 62.96 | percentage of particpants | ||
| Subjects With at Least One Form of Contact With Study Staff With no Herpes Labialis Outbreaks Within 119 Days of Sensitization | Placebo Solution | 20 | percentage of particpants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0.2% Squaric Acid | 17 | |
| Overall Study | STARTED | 0.5% Squaric Acid | 18 | |
| Overall Study | STARTED | Placebo Solution | 19 | |
| Overall Study | COMPLETED | 0.2% Squaric Acid | 14 | |
| Overall Study | COMPLETED | 0.5% Squaric Acid | 13 | |
| Overall Study | COMPLETED | Placebo Solution | 15 | |
| Overall Study | NOT COMPLETED | 0.2% Squaric Acid | 3 | |
| Overall Study | NOT COMPLETED | 0.5% Squaric Acid | 5 | |
| Overall Study | NOT COMPLETED | Placebo Solution | 4 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Non Serious Itching, Redness, or Swelling | Skin and subcutaneous tissue disorders | 0.2% Squaric Acid | 8 | 17 | 8 |
| other | Non Serious Itching, Redness, or Swelling | Skin and subcutaneous tissue disorders | 0.5% Squaric Acid | 5 | 18 | 5 |
| other | Non Serious Itching, Redness, or Swelling | Skin and subcutaneous tissue disorders | Placebo Solution | 2 | 19 | 2 |
| other | Other Non Serious AE | Skin and subcutaneous tissue disorders | 0.2% Squaric Acid | 1 | 17 | 1 |
| other | Other Non Serious AE | Skin and subcutaneous tissue disorders | 0.5% Squaric Acid | 1 | 18 | 1 |
| other | Other Non Serious AE | Skin and subcutaneous tissue disorders | Placebo Solution | 1 | 19 | 1 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.2% Squaric Acid | ||
| Total, all-cause mortality | 0.5% Squaric Acid | ||
| Total, all-cause mortality | Placebo Solution | ||
| Total, other adverse events | 0.2% Squaric Acid | 9 | 17 |
| Total, other adverse events | 0.5% Squaric Acid | 6 | 18 |
| Total, other adverse events | Placebo Solution | 3 | 19 |
| Total, serious adverse events | 0.2% Squaric Acid | 0 | 17 |
| Total, serious adverse events | 0.5% Squaric Acid | 0 | 18 |
| Total, serious adverse events | Placebo Solution | 0 | 19 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01971385
GET https://conductscience.org/api/trials/v1/NCT01971385/registered