NCT03900676

Efficacy and Safety Study of VB-1953 Topical Gel for Inflammatory Facial Acne Vulgaris

A Phase 2, Randomized, Multicenter, Double-blind, Vehicle-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of VB-1953 Topical Gel When Applied Once or Twice Daily for 12 Weeks in Subjects With Moderate to Severe Inflammatory Facial Acne Vulgaris

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Vyome Therapeutics Inc. · Industry
• Sex: All
• Age: 9 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Dose-ranging Study in the Treatment of Acne Vulgaris,

Detailed description

This will be a Phase 2, multicenter, randomized, double-blinded, dose-ranging, parallel arm comparison study in male and non-pregnant female subjects, 9 through 45 years of age (inclusive) with facial acne vulgaris. This dose-ranging study, intended to identify the dose(s), will consist of 7 study visits over 14 weeks:

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	VB-1953 - 2%	Topical Gel
DRUG	VB-1953 - 0% (Vehicle)	Topical Gel

Timeline

• Start date: 2019-04-09
• Primary completion: 2019-11-01
• Completion: 2020-03-01
• First posted: 2019-04-03
• Last updated: 2019-10-01

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study