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

NCT03680131 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2024-11-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • JSS Medical Research Inc.

    collaborator INDUSTRY

  • Edesa Biotech Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-15
Primary Completion
2022-09-21
Completion
2023-01-17
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03680131 on ClinicalTrials.gov