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

Phase 2

Completed

• Conditions: Allergic Contact Dermatitis
• Interventions: Drug: EB01 Cream Placebo; Drug: EB01 Cream 0.2%; Drug: EB01 Cream 1.0%; Drug: EB01 Cream 2.0%

• Registration Number: NCT03680131
• Lead Sponsor: Edesa Biotech Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-19
• Study First Submitted QC: 2018-09-19
• Study First Posted: 2018-09-21
• Study Start: 2019-10-15
• Primary Completion: 2022-09-21
• Study Completion: 2023-01-17
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EB01 Cream Placebo	EB01 Cream Placebo	EB01 Cream containing 0% EB01 w/w applied BID
EB01 Cream 0.2%	EB01 Cream 0.2%	EB01 Cream containing 0.2% EB01 w/w applied BID
EB01 Cream 1.0%	EB01 Cream 1.0%	EB01 Cream containing 1.0% EB01 w/w applied BID
EB01 Cream 2.0%	EB01 Cream 2.0%	EB01 Cream containing 2.0% EB01 w/w applied BID

Primary Outcome Measures

Name	Time	Method
Mean percent change from baseline in the Contact Dermatitis Severity Index (CDSI)	Day 29

Secondary Outcome Measures

Name	Time	Method
Proportion of patients achieving at least a 4-point reduction from peak pruritis Numerical Rating Scale (NRS) score from Baseline	Days 15, 29, 59, 89, and 119
Change from baseline in Dermatology Life Quality Index (DLQI)	Days 15, 29, 59, 89, and 119
Proportion of patients achieving at least a 2-point reduction from peak pruritis Numerical Rating Scale (NRS) score from Baseline	Days 15, 29, 59, 89, and 119
Mean percent change from baseline in CDSI	Days 15, 59, 89, and 119
Proportion of subjects achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in Investigator's Static Global Assessment (ISGA)	Days 15, 29, 59, 89, and 119
Mean percent change from baseline in Body Surface Area (BSA) affected with chronic allergic contact dermatitis	Days 15, 29, 59, 89, and 119

Trial Locations

Locations (15)

Oakland Hills Dermatology P.C.; 🇺🇸 Auburn Hills, Michigan, United States

Apex Clinical Research Center, LLC; 🇺🇸 Mayfield Heights, Ohio, United States

Ark Clinical Research; 🇺🇸 Long Beach, California, United States

Foxhall Dermatology; 🇺🇸 Washington, District of Columbia, United States

Gold Coast Dermatology; 🇺🇸 Delray Beach, Florida, United States

Miami Dade Medical Research Institute, LLC; 🇺🇸 Miami, Florida, United States

The Dermatology Centre of Indiana; 🇺🇸 Plainfield, Indiana, United States

Forefront Dermatology; 🇺🇸 Louisville, Kentucky, United States

The Dermatology Clinic; 🇺🇸 Baton Rouge, Louisiana, United States

Associated Skin Care Specialists; 🇺🇸 Fridley, Minnesota, United States

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