An Observer-Blinded, Randomized, Aqueous Gel-Controlled Trial of the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Onychomycosis

NCT05491603 Phase 2 SUSPENDED

This is a randomized, observer-blinded, Aqueous Gel-controlled trial examining the safety and efficacy of daily application of DBI-001 Gel vs. DBI-002 Gel vs. Aqueous Gel for 24 consecutive weeks in subjects with onychomycosis.

Details

Lead sponsor	DermBiont, Inc.
Phase	Phase 2
Status	SUSPENDED
Enrolment	60
Start date	2023-11
Completion	2023-11-30

Conditions

• Onychomycosis

Interventions

• DBI-001
• DBI-002
• Aqueous Gel

Primary outcomes

• Change in percentage of involved great toenail(s) — 24 weeks of participation
  Absolute change from Baseline in percent of involved treatment-targeted great toenail(s) at Week 24.
• Changes in signs and symptoms of Onychomycosis — Baseline through End of Study (up to 48 weeks of participation)
  Change from baseline in individual signs and symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 of sites treated with DBI-001 Gel or DBI-002 Gel. The minimum value is 0 and the maximum value is 4.

Countries

United States