At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 139 enrolled
Drug / intervention
SADBE +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multi-site, Randomized, Double-blind, Vehicle-controlled Study of the Efficacy and Safety of Squaric Acid Dibutyl Ester (SADBE) in Subjects With Recurrent Herpes Labialis - Single Versus Two-dose Arm Application
In Brief
A Phase 2 clinical trial evaluating SADBE and Placebo for Herpes Labialis and Cold Sore. Completed, enrolled 139 participants across 5 sites.
Detailed Summary
This study evaluates the safety and efficacy of SADBE in the prevention of recurrent herpes labialis in adults. Two-thirds of the participants will receive a SADBE solution, while the other third will receive only the vehicle as a placebo control. The solutions will be administered topically to the patient's arms. The study will compare a single-arm application versus a two-arm application versus two placebo doses on the arm.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHerpes Labialis, Cold Sore
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartDec 2016
Primary CompletionDec 2018
TodayJul 2026
First PostedNov 17, 2016
Enrollment StartDec 1, 2016
Primary CompletionDec 20, 2018
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.6 years ago
Interventions
SADBEdrug
Topical solution
Placeboother
Topical solution