Allergic Contact DermatitisPhase 2NCT03680131
Evaluation of EB01 Cream for the Treatment of Chronic Allergic Contact Dermatitis
A Phase 2 study testing EB01 Cream 0.2%, EB01 Cream 1.0% and EB01 Cream 2.0% in people with Allergic Contact Dermatitis, run by Edesa Biotech Inc. at 15 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Contact Dermatitis
- What is being tested?
- EB01 Cream 0.2%, EB01 Cream 1.0% and EB01 Cream 2.0%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 211 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 15 Oct 2019to 17 Jan 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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 study period (patch testing needs to be completed by Day 36). 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.
Who cannot join
- 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.
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- 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 2 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 1 week 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.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States14 sites
Oakland Hills Dermatology P.C.
Auburn Hills, Michigan, 48326
The Dermatology Clinic
Baton Rouge, Louisiana, 70808
Bexly Dermatology
Bexley, Ohio, 43209
UNC Dermatology and Skin Cancer Center
Chapel Hill, North Carolina, 27516
Gold Coast Dermatology
Delray Beach, Florida, 33446
Associated Skin Care Specialists
Fridley, Minnesota, 55432
Ark Clinical Research
Long Beach, California, 90806
Forefront Dermatology
Louisville, Kentucky, 40202
Apex Clinical Research Center, LLC
Mayfield Heights, Ohio, 44124
Miami Dade Medical Research Institute, LLC
Miami, Florida, 33176
West Virginia Research Institute
Morgantown, West Virginia, 26505
JUVA Skin & Laser Center
New York, New York, 10022
The Dermatology Centre of Indiana
Plainfield, Indiana, 46168
Foxhall Dermatology
Washington D.C., District of Columbia, 20016
About this study
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 Moderate to Severe Chronic Allergic Contact Dermatitis
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
- Being tested
- EB01 Cream Placebo, EB01 Cream 0.2%, EB01 Cream 1.0%, EB01 Cream 2.0%
- Medical subject headings
- Dermatitis, Allergic Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EB01 Cream PlaceboDrug
Vehicle Cream containing 0% EB w/w applied BID
EB01 Cream 0.2%Drug
EB01 Cream containing 0.2% EB01 w/w applied BID
EB01 Cream 1.0%Drug
EB01 Cream containing 1.0% EB01 w/w applied BID
EB01 Cream 2.0%Drug
EB01 Cream containing 2.0% EB01 w/w applied BID
| Study group | Role | What they receive |
|---|---|---|
| EB01 Cream Placebo | Active comparator | EB01 Cream containing 0% EB01 w/w applied BID Receives: Drug: EB01 Cream Placebo |
| EB01 Cream 0.2% | Experimental | EB01 Cream containing 0.2% EB01 w/w applied BID Receives: Drug: EB01 Cream 0.2% |
| EB01 Cream 1.0% | Experimental | EB01 Cream containing 1.0% EB01 w/w applied BID Receives: Drug: EB01 Cream 1.0% |
| EB01 Cream 2.0% | Experimental | EB01 Cream containing 2.0% EB01 w/w applied BID Receives: Drug: EB01 Cream 2.0% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percent change from baseline in the Contact Dermatitis Severity Index (CDSI)
Measured: Day 29
Secondary outcomes (6)
Mean percent change from baseline in CDSI
Measured: 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)
Measured: Days 15, 29, 59, 89, and 119
Mean percent change from baseline in Body Surface Area (BSA) affected with chronic allergic contact dermatitis
Measured: Days 15, 29, 59, 89, and 119
Change from baseline in Dermatology Life Quality Index (DLQI)
Measured: 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
Measured: Days 15, 29, 59, 89, and 119
Proportion of patients achieving at least a 4-point reduction from peak pruritis Numerical Rating Scale (NRS) score from Baseline
Measured: Days 15, 29, 59, 89, and 119
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start15 Oct 2019
- Primary completion21 Sep 2022
- Study completion17 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Contact DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edesa Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- JSS Medical Research Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680131
- Sponsor's protocol ID
- EB01-01-2018
- Status last verified
- Nov 2024
- First submitted
- 19 Sep 2018
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Moderate to Severe Chronic Allergic Contact Dermatitis
- ClinicalTrials.gov ID
- NCT03680131
- Acronym / sponsor ID
- EB01-01-2018
- Conditions
- Allergic Contact Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Edesa Biotech Inc.Industry (pharma, biotech, devices)
- Collaborators
- JSS Medical Research Inc.
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 21 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EB01 Cream Placebo | Active comparator | Drug: EB01 Cream PlaceboEB01 Cream containing 0% EB01 w/w applied BID |
| EB01 Cream 0.2% | Experimental | Drug: EB01 Cream 0.2%EB01 Cream containing 0.2% EB01 w/w applied BID |
| EB01 Cream 1.0% | Experimental | Drug: EB01 Cream 1.0%EB01 Cream containing 1.0% EB01 w/w applied BID |
| EB01 Cream 2.0% | Experimental | Drug: EB01 Cream 2.0%EB01 Cream containing 2.0% EB01 w/w applied BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 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.
- 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.
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EB01 Cream PlaceboVehicle Cream containing 0% EB w/w applied BID | Drug | EB01 Cream Placebo |
| EB01 Cream 0.2%EB01 Cream containing 0.2% EB01 w/w applied BID | Drug | EB01 Cream 0.2% |
| EB01 Cream 1.0%EB01 Cream containing 1.0% EB01 w/w applied BID | Drug | EB01 Cream 1.0% |
| EB01 Cream 2.0%EB01 Cream containing 2.0% EB01 w/w applied BID | Drug | EB01 Cream 2.0% |
Primary outcome
Mean percent change from baseline in the Contact Dermatitis Severity Index (CDSI)
Time frame: Day 29
6 secondary outcomes
Mean percent change from baseline in CDSI
Time frame: 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)
Time frame: Days 15, 29, 59, 89, and 119
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
Change from baseline in Dermatology Life Quality Index (DLQI)
Time frame: 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
Time frame: Days 15, 29, 59, 89, and 119
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EB01 Cream 0.2%, EB01 Cream 1.0% and EB01 Cream 2.0% in people with Allergic Contact Dermatitis, run by Edesa Biotech Inc. at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean percent change from baseline in the Contact Dermatitis Severity Index (CDSI) (time frame: Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.