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

Primary Purpose

Allergic Contact Dermatitis

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
EB01 Cream Placebo
EB01 Cream 0.2%
EB01 Cream 1.0%
EB01 Cream 2.0%
Sponsored by
Edesa Biotech Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Contact Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA

All subjects:

  1. Men and women ≥ 18 years old, inclusive, at the time of consent.
  2. 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:

    1. Woman who has had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy);
    2. 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).
  3. For men involved in any sexual intercourse that could lead to pregnancy, subject must agree to use one of the effective contraceptive methods listed in Inclusion Criterion #2 from Day 1 until at least 4 weeks after the last study product application. If the female partner of a male subject use any of the hormonal contraceptive methods listed above, this contraceptive method must be used by the female partner from at least 4 weeks before Day 1 until at least 4 weeks after the last study product application.
  4. Female of childbearing potential has had a negative pregnancy test at screening visit .
  5. Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
  6. Subjects must be willing to comply with all study procedures and must be available for the duration of the study.

HV only:

1. 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:

  1. 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).
  2. Subject has moderate to severe chronic allergic contact dermatitis at Day 1, defined by either one of the following:

    • CDSI score ≥ 7
    • CDSI score of severe (3) in ≥ 2 of the 5 assessed symptoms (Fissures, Scaling Redness, Pruritus, Dryness)
  3. Subject has allergic contact dermatitis covering between 0.5% to 10% of the total BSA at Day 1.
  4. Subject has an ISGA ≥ 3 at Day 1.
  5. The subject has had a positive patch test ("+", "++" or "+++" reaction) to an allergen that is suspected to be involved in the current allergic contact dermatitis in the past 5 years (obtain written documentation of patch test result if possible).

    Alternatively, the Subject agrees to undergo patch testing during the screening period (patch testing needs to be initiated but not completed prior to Day 1). Guidelines for patch test interpretation are provided in Appendix 2. The measure of the degree of the reaction will be determined on the basis of the reading 2 and 3-4 days post application.

  6. Subject agrees to only apply personal care products (i.e. makeup and eyeshadow) that do not contain their allergen(s) on lesions only after applying the IP.
  7. Subject agrees not to apply any personal care products on allergic contact dermatitis lesions prior to site visits.

Subjects with allergic contact dermatitis in the Open Label Extension:

1. Subject has completed the main study.

EXCLUSION CRITERIA

All subjects:

  1. Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
  2. 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.
  3. 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.
  4. Subject is known to have immune deficiency or is immunocompromised.
  5. 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.
  6. Subject had a major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.
  7. 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.
  8. Subject has a known history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or infection with human immunodeficiency virus).
  9. 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.
  10. 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.
  11. Subject has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
  12. Subject is currently receiving a nonbiological investigational product or device or has received one within 2 weeks prior to Day 1.
  13. Subject has received any UV-B phototherapy (including tanning beds) or excimer laser within 2 weeks prior to Day 1.
  14. 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.
  15. Subject has a known hypersensitivity to EB01 or its excipients.
  16. Subject has uncontrolled diabetes.
  17. Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.

HV only:

  1. Subject has history of recurrent chronic or presence of allergic contact dermatitis.
  2. Subject has used any medicated topical product on the face within 2 weeks prior to Day 1.

Subjects with allergic contact dermatitis only:

  1. Subjects with active atopic dermatitis lesions overlapping with allergic contact dermatitis lesions at Day 1.
  2. Subject has clinically infected allergic contact dermatitis lesions (bacterial, viral, or fungal).
  3. Subject has allergic contact dermatitis on lips or mucous membranes only.
  4. Subject has used dupilumab within 12 weeks prior to Day 1.
  5. Subject has used doxepin within 1 week prior to Day 1.
  6. Subject has used hydroxyzine or diphenhydramine within 1 week prior to Day 1.
  7. Subject has used topical products containing urea within 1 week prior to Day 1.
  8. Subject has used systemic antibiotics within 1 weeks or topical antibiotics on lesions of allergic contact dermatitis within 1 week prior to Day 1.
  9. Subject has used any topical medicated treatment for allergic contact dermatitis within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, crisaborole and any other topical phosphodiesterase-4 inhibitor, calcineurin inhibitors, tars, bleach, antimicrobials and medical devices.

Sites / Locations

  • Ark Clinical Research
  • Foxhall Dermatology
  • Gold Coast Dermatology
  • Miami Dade Medical Research Institute, LLC
  • The Dermatology Centre of Indiana
  • Forefront Dermatology
  • The Dermatology Clinic
  • Associated Skin Care Specialists
  • JUVA Skin & Laser Center
  • UNC Dermatology and Skin Cancer Center
  • Bexly Dermatology
  • West Virginia Research Institute
  • Lynderm Research Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

EB01 Cream Placebo

EB01 Cream 0.2%

EB01 Cream 1.0%

EB01 Cream 2.0%

Arm Description

EB01 Cream containing 0% EB01 w/w applied BID

EB01 Cream containing 0.2% EB01 w/w applied BID

EB01 Cream containing 1.0% EB01 w/w applied BID

EB01 Cream containing 2.0% EB01 w/w applied BID

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean percent change from baseline in CDSI
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)
Proportion of patients achieving at least a 2-point reduction from peak pruritis Numerical Rating Scale (NRS) score from Baseline
Proportion of patients achieving at least a 4-point reduction from peak pruritis Numerical Rating Scale (NRS) score from Baseline
Mean percent change from baseline in Body Surface Area (BSA) affected with chronic allergic contact dermatitis
Change from baseline in Dermatology Life Quality Index (DLQI)

Full Information

First Posted
September 19, 2018
Last Updated
September 9, 2022
Sponsor
Edesa Biotech Inc.
Collaborators
JSS Medical Research Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03680131
Brief Title
Evaluation of EB01 Cream for the Treatment of Chronic Allergic Contact Dermatitis
Official Title
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 Chronic Allergic Contact Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edesa Biotech Inc.
Collaborators
JSS Medical Research Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Contact Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EB01 Cream Placebo
Arm Type
Active Comparator
Arm Description
EB01 Cream containing 0% EB01 w/w applied BID
Arm Title
EB01 Cream 0.2%
Arm Type
Experimental
Arm Description
EB01 Cream containing 0.2% EB01 w/w applied BID
Arm Title
EB01 Cream 1.0%
Arm Type
Experimental
Arm Description
EB01 Cream containing 1.0% EB01 w/w applied BID
Arm Title
EB01 Cream 2.0%
Arm Type
Experimental
Arm Description
EB01 Cream containing 2.0% EB01 w/w applied BID
Intervention Type
Drug
Intervention Name(s)
EB01 Cream Placebo
Intervention Description
Vehicle Cream containing 0% EB w/w applied BID
Intervention Type
Drug
Intervention Name(s)
EB01 Cream 0.2%
Intervention Description
EB01 Cream containing 0.2% EB01 w/w applied BID
Intervention Type
Drug
Intervention Name(s)
EB01 Cream 1.0%
Intervention Description
EB01 Cream containing 1.0% EB01 w/w applied BID
Intervention Type
Drug
Intervention Name(s)
EB01 Cream 2.0%
Intervention Description
EB01 Cream containing 2.0% EB01 w/w applied BID
Primary Outcome Measure Information:
Title
Mean percent change from baseline in the Contact Dermatitis Severity Index (CDSI)
Time Frame
Day 29
Secondary Outcome Measure Information:
Title
Mean percent change from baseline in CDSI
Time Frame
Days 15, 59, 89, and 119
Title
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)
Time Frame
Days 15, 29, 59, 89, and 119
Title
Proportion of patients achieving at least a 2-point reduction from peak pruritis Numerical Rating Scale (NRS) score from Baseline
Time Frame
Days 15, 29, 59, 89, and 119
Title
Proportion of patients achieving at least a 4-point reduction from peak pruritis Numerical Rating Scale (NRS) score from Baseline
Time Frame
Days 15, 29, 59, 89, and 119
Title
Mean percent change from baseline in Body Surface Area (BSA) affected with chronic allergic contact dermatitis
Time Frame
Days 15, 29, 59, 89, and 119
Title
Change from baseline in Dermatology Life Quality Index (DLQI)
Time Frame
Days 15, 29, 59, 89, and 119
Other Pre-specified Outcome Measures:
Title
Treatment-emergent adverse events (TEAEs)
Description
Number of events
Time Frame
To Day 36, and for open-label extension to Day 119
Title
Tolerability assessed using a numerical rating scale
Description
Tolerability will be assessed using a numerical rating scale from 0 to 10, and will evaluate skin burning, stinging and pruritus during treatment
Time Frame
To Day 36, and for open-label extension to Day 119

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA 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). For men involved in any sexual intercourse that could lead to pregnancy, subject must agree to use one of the effective contraceptive methods listed in Inclusion Criterion #2 from Day 1 until at least 4 weeks after the last study product application. If the female partner of a male subject use any of the hormonal contraceptive methods listed above, this contraceptive method must be used by the female partner from at least 4 weeks before Day 1 until at least 4 weeks after the last study product application. 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: 1. 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). Subject has moderate to severe chronic allergic contact dermatitis at Day 1, defined by either one of the following: CDSI score ≥ 7 CDSI score of severe (3) in ≥ 2 of the 5 assessed symptoms (Fissures, Scaling Redness, Pruritus, Dryness) Subject has allergic contact dermatitis covering between 0.5% to 10% of the total BSA at Day 1. Subject has an ISGA ≥ 3 at Day 1. The subject has had a positive patch test ("+", "++" or "+++" reaction) to an allergen that is suspected to be involved in the current allergic contact dermatitis in the past 5 years (obtain written documentation of patch test result if possible). Alternatively, the Subject agrees to undergo patch testing during the screening period (patch testing needs to be initiated but not completed prior to Day 1). Guidelines for patch test interpretation are provided in Appendix 2. The measure of the degree of the reaction will be determined on the basis of the reading 2 and 3-4 days post application. Subject agrees to only apply personal care products (i.e. makeup and eyeshadow) that do not contain their allergen(s) on lesions only after applying the IP. Subject agrees not to apply any personal care products on allergic contact dermatitis lesions prior to site visits. Subjects with allergic contact dermatitis in the Open Label Extension: 1. Subject has completed the main study. EXCLUSION CRITERIA 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. Subject has a known hypersensitivity to EB01 or its excipients. Subject has uncontrolled diabetes. Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1. HV only: Subject has history of recurrent chronic or presence of allergic contact dermatitis. Subject has used any medicated topical product on the face within 2 weeks prior to Day 1. Subjects with allergic contact dermatitis only: Subjects with active atopic dermatitis lesions overlapping with allergic contact dermatitis lesions at Day 1. Subject has clinically infected allergic contact dermatitis lesions (bacterial, viral, or fungal). Subject has allergic contact dermatitis on lips or mucous membranes only. Subject has used dupilumab within 12 weeks prior to Day 1. Subject has used doxepin within 1 week prior to Day 1. Subject has used hydroxyzine or diphenhydramine within 1 week prior to Day 1. Subject has used topical products containing urea within 1 week prior to Day 1. Subject has used systemic antibiotics within 1 weeks or topical antibiotics on lesions of allergic contact dermatitis within 1 week prior to Day 1. Subject has used any topical medicated treatment for allergic contact dermatitis within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, crisaborole and any other topical phosphodiesterase-4 inhibitor, calcineurin inhibitors, tars, bleach, antimicrobials and medical devices.
Facility Information:
Facility Name
Ark Clinical Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Foxhall Dermatology
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Gold Coast Dermatology
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33446
Country
United States
Facility Name
Miami Dade Medical Research Institute, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
The Dermatology Centre of Indiana
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Forefront Dermatology
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
The Dermatology Clinic
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Associated Skin Care Specialists
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
JUVA Skin & Laser Center
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
UNC Dermatology and Skin Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
Facility Name
Bexly Dermatology
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Facility Name
West Virginia Research Institute
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
Lynderm Research Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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