| Eligibility |
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.
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