An Open Label Study to Evaluate the Safety and Efficacy of BOR15001L7 for the Treatment of Cold Sores in Patients With Recurrent Herpes Labialis

Recurrent Herpes Labialis Clinical Trial

Official title: A Randomized, Open Label, Non-inferiority Study to Compare the Safety and Efficacy of BOR15001L7 to Docosanol 10% in Patients With Recurrent Herpes Labialis

Status Not yet recruiting

Clinical Trial Summary

BOR15001L7 is a natural product. The primary objective of this study is to demonstrate its non-inferiority to docosanol 10% based on the healing time of cold sores in patients with recurrent herpes labialis.

Clinical Trial Description

Secondary objectives are to:

1. Evaluate the efficacy of BOR1500L7 on:

• The reduction of ulcerative lesions rates following the prodromal stage;

• The extension of the delay prior to first ulcerative lesions occurence following the prodromal stage;

• The decrease of cumulative ulcerative lesions dimensions during papule, vesicles, ulcers/soft and hard crust stages;

• The decrease of symptoms intensity (pain, tingling, itching, burning sensation) during prodromal, erythema, papule, vesicles, ulcers/soft crust, hard crust, re-epithelialize stages;

• The reduction of symptoms duration (pain, tingling, itching, burning sensation) during the prodromal, erythema, papule, vesicles, ulcers/soft crust, hard crust, re-epithelialize stages in subjects with recurrent herpes labialis;

2. Evaluate the safety and tolerability of BOR15001L7 in subjects with recurrent herpes labialis ;

Related Conditions & MeSH terms

• Herpes Labialis
• Recurrent Herpes Labialis

• NCT number: NCT03977792
• Study type: Interventional
• Source: Laboratoire Boreaderme Inc.
• Contact: Etienne Khoury, PhD, CCRP
• Phone: (418) 545-1252
• Email: etienne.khoury@ecogene21.org
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 2020
• Completion date: July 2022