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

NCT03680131 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: EB01-01-2018
• Study Type: interventional
• Target: 211
• Locations: 2 countries
• Sites: 15

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.

Conditions

Allergic Contact Dermatitis

Outcome Measures

Primary Outcomes (1)

• Mean percent change from baseline in the Contact Dermatitis Severity Index (CDSI)

  Day 29

Secondary Outcomes (6)

• 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

• 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

Other Outcomes (2)

• Treatment-emergent adverse events (TEAEs)

  To Day 36, and for open-label extension to Day 119

• Safety and tolerability assessments

  To Day 36, and for open-label extension to Day 119

Study Arms (4)

EB01 Cream Placebo

ACTIVE COMPARATOR

EB01 Cream containing 0% EB01 w/w applied BID

Drug: EB01 Cream Placebo

EB01 Cream 0.2%

EXPERIMENTAL

EB01 Cream containing 0.2% EB01 w/w applied BID

Drug: EB01 Cream 0.2%

EB01 Cream 1.0%

EXPERIMENTAL

EB01 Cream containing 1.0% EB01 w/w applied BID

Drug: EB01 Cream 1.0%

EB01 Cream 2.0%

EXPERIMENTAL

EB01 Cream containing 2.0% EB01 w/w applied BID

Drug: EB01 Cream 2.0%

Interventions

EB01 Cream Placebo DRUG

Vehicle Cream containing 0% EB w/w applied BID

EB01 Cream Placebo

EB01 Cream 0.2% DRUG

EB01 Cream containing 0.2% EB01 w/w applied BID

EB01 Cream 0.2%

EB01 Cream 1.0% DRUG

EB01 Cream containing 1.0% EB01 w/w applied BID

EB01 Cream 1.0%

EB01 Cream 2.0% DRUG

EB01 Cream containing 2.0% EB01 w/w applied BID

EB01 Cream 2.0%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects:
• Men and women ≥ 18 years old, inclusive, at the time of consent.
• For women of childbearing potential involved in any sexual intercourse that could lead to pregnancy: the subject must agree to use an effective contraceptive method from at least 4 weeks before Day 1 until at least 4 weeks after the last study product application. Effective contraceptive methods include hormonal contraceptives (combined oral contraceptive, patch, vaginal ring, injectable, or implant), intrauterine devices or intrauterine systems, vasectomized partner(s), tubal ligation, or a barrier method of contraception (male condom, female condom, cervical cap, diaphragm, contraceptive sponge) in conjunction with spermicide.
• Note: Subjects must have been on a stable dose of hormonal contraceptives for at least 4 weeks before Day 1.
• Note: The above list of contraceptive methods does not apply to subjects who are abstinent for at least 4 weeks before Day 1 and will continue to be abstinent from penile-vaginal intercourse throughout the study. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant.
• Note: A woman of nonchildbearing potential is as follows:
• Woman who has had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy);
• Woman who has had a cessation of menses for at least 12 months without an alternative medical cause, and a follicle-stimulating hormone (FSH) test confirming nonchildbearing potential (refer to laboratory reference ranges for confirmatory levels).
• Female of childbearing potential has had a negative pregnancy test at screening visit.
• Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
• Subjects must be willing to comply with all study procedures and must be available for the duration of the study.
• HV only:
• \. Subject is in good general health, according to the investigator's judgment based on medical history and physical examination/laboratory/ECG/vital signs assessments.
• Subjects with allergic contact dermatitis only:
• Subject has at least 3-month history of allergic contact dermatitis (information obtained from medical chart or subject's physician, or directly from the subject).

You may not qualify if:

• All subjects:
• Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
• Current or recurrent disease, other than allergic contact dermatitis (applicable to subject with allergic contact dermatitis only), that could affect the action, absorption, or disposition of the study drug, or clinical or laboratory assessments.
• Subject has a history of skin disease or presence of skin condition, other than allergic contact dermatitis (applicable to subject with allergic contact dermatitis only) that, in the opinion of the investigator, would interfere with the study assessments.
• Subject is known to have immune deficiency or is immunocompromised.
• Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1. Subjects with successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix are not to be excluded.
• Subject had a major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.
• Subject has any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
• Subject has a known history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or infection with human immunodeficiency virus).
• Subject has used systemic treatments (other than biologics) that could affect allergic contact dermatitis (applicable to subjects with allergic contact dermatitis only) or is known to cause cutaneous irritation or sensitization reactions less than 2 weeks prior to Day 1 (e.g., oral/injectable corticosteroids, retinoids, calcineurin inhibitors, methotrexate, cyclosporine, hydroxycarbamide \[hydroxyurea\], azathioprine) Note: Intranasal corticosteroids and inhaled corticosteroids for stable medical conditions are allowed. Eye drops containing corticosteroids are allowed.
• Use of any prescription or over-the-counter (OTC) medication that, in the opinion of the Principal Investigator, could affect (improve or worsen) the allergic contact dermatitis condition or is known to cause cutaneous irritation or sensitization reactions.
• Subject has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
• Subject is currently receiving a nonbiological investigational product or device or has received one within 2 weeks prior to Day 1.
• Subject has received any UV-B phototherapy (including tanning beds) or excimer laser within 2 weeks prior to Day 1.
• Subject had excessive sun exposure, is planning a trip to a sunny climate, or has used tanning booths within 2 weeks prior to Day 1 or is not willing to minimize natural and artificial sunlight exposure during the study. Use of sunscreen products and protective apparel are recommended when exposure cannot be avoided. If sunscreen is applied to ACD lesions, it should be applied after the IP.

Sponsors & Collaborators

• Edesa Biotech Inc.: lead
• JSS Medical Research Inc.: collaborator

Study Sites (15)

Ark Clinical Research

Long Beach, California, 90806, United States

Location

Foxhall Dermatology

Washington D.C., District of Columbia, 20016, United States

Location

Gold Coast Dermatology

Delray Beach, Florida, 33446, United States

Location

Miami Dade Medical Research Institute, LLC

Miami, Florida, 33176, United States

Location

The Dermatology Centre of Indiana

Plainfield, Indiana, 46168, United States

Location

Forefront Dermatology

Louisville, Kentucky, 40202, United States

Location

The Dermatology Clinic

Baton Rouge, Louisiana, 70808, United States

Location

Oakland Hills Dermatology P.C.

Auburn Hills, Michigan, 48326, United States

Location

Associated Skin Care Specialists

Fridley, Minnesota, 55432, United States

Location

JUVA Skin & Laser Center

New York, New York, 10022, United States

Location

UNC Dermatology and Skin Cancer Center

Chapel Hill, North Carolina, 27516, United States

Location

Bexly Dermatology

Bexley, Ohio, 43209, United States

Location

Apex Clinical Research Center, LLC

Mayfield Heights, Ohio, 44124, United States

Location

West Virginia Research Institute

Morgantown, West Virginia, 26505, United States

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X2, Canada

Location

MeSH Terms

Conditions

Dermatitis, Allergic Contact

Condition Hierarchy (Ancestors)

Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 21, 2018
• Study Start: October 15, 2019
• Primary Completion: September 21, 2022
• Study Completion: January 17, 2023
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (14); CA (1)