NCT02965781

Double-blind, Vehicle-controlled Study of the Efficacy and Safety of SADBE in Subjects With Recurrent Herpes Labialis

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Squarex, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Herpes Labialis
• Cold Sore

Interventions

Type	Name	Description
DRUG	SADBE	Topical solution
OTHER	Placebo	Topical solution

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-12-20
• Completion: 2018-12-20
• First posted: 2016-11-17
• Last updated: 2021-11-02
• Results posted: 2021-11-02

Locations

5 sites across 1 country: United States