NCT03977792

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

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: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Laboratoire Boreaderme Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Recurrent Herpes Labialis

Interventions

Type	Name	Description
DRUG	BOR15001L7	BOR15001L7 topically applied to infected area, 5 times a day, until complete healing of the infection.
DRUG	Docosanol Cream 10%	Comparator product topically applied to infected area, 5 times a day, until complete healing of the infection.

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-07-01
• Completion: 2022-07-01
• First posted: 2019-06-06
• Last updated: 2020-09-07