NCT03680131

Evaluation of EB01 Cream for the Treatment of Chronic Allergic Contact Dermatitis

A Randomized, Double-Blind, Vehicle-Controlled, Sample Size Adaptive Design Study to Evaluate the Safety and Efficacy of Topically Applied EB01 Cream in Healthy Adult Volunteers and Adult Subjects with Moderate to Severe Chronic Allergic Contact Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Edesa Biotech Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of EB01 Cream (0.2%, 1.0%, 2.0%) applied twice per day (BID) for the treatment of moderate to severe chronic allergic contact dermatitis (ACD). The purpose of the open label extension is to assess the long-term safety, tolerability, and efficacy of EB01 2.0% cream in subjects with moderate to severe chronic allergic contact dermatitis.

Conditions

• Allergic Contact Dermatitis

Interventions

Type	Name	Description
DRUG	EB01 Cream Placebo	Vehicle Cream containing 0% EB w/w applied BID
DRUG	EB01 Cream 0.2%	EB01 Cream containing 0.2% EB01 w/w applied BID
DRUG	EB01 Cream 1.0%	EB01 Cream containing 1.0% EB01 w/w applied BID
DRUG	EB01 Cream 2.0%	EB01 Cream containing 2.0% EB01 w/w applied BID

Timeline

• Start date: 2019-10-15
• Primary completion: 2022-09-21
• Completion: 2023-01-17
• First posted: 2018-09-21
• Last updated: 2024-11-14

Locations

15 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study