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NCT01971385 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Massachusetts General Hospital.

Completed
Registry status
Phase 1
Development phase
54
Enrollment target

NCT01971385: Completed Phase 1 study, sponsored by Massachusetts General Hospital.

NCT01971385 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01971385, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Phase 1
Development phase
54 participants
Enrollment target

Study Summary

Subjects with a history of recurrent herpes labialis will be sensitized with either 2% SADBE or placebo. Following this, subjects sensitized with 2% SADBE will received.2% sqauric acid or.5% squaric acid on their cold sore within 72 hours of a recurrence. Subjects sensitized with placebo solution will receive placebo solution on their cold sore within 72 hours of a recurrence. Subjects will be followed for up to 6 mos after application of study medication.

Primary Outcome

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

Interventions

  • DRUG Placebo solution
  • DRUG Squaric Acid solution

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2013-10
Est. Completion 2015-09
Phase Phase 1
Massachusetts General Hospital

2,032 total trials

What the finished NCT01971385 record still lists

NCT01971385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo solution is the first listed.

NCT01971385 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01971385 about?

NCT01971385 is a clinical study titled "Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis". Subjects with a history of recurrent herpes labialis will be sensitized with either 2% SADBE or placebo. Following this, subjects sensitized with 2% SADBE will received.2% sqauric acid or.5% squaric acid on their cold sore within 72 hours of a recurrence. Subjects sensitized with placebo solution wi...

What is the current status of trial NCT01971385?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2013-10. Estimated completion is 2015-09.

What interventions are being tested in trial NCT01971385?

The interventions under investigation include: Placebo solution (DRUG), Squaric Acid solution (DRUG).

Who is sponsoring clinical trial NCT01971385?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01971385's enrollment target sits among peer trials

54 931st of 2000 higher than 1,053 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01971385, the US trial registry maintained by the National Library of Medicine. NCT01971385 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.