| Eligibility |
Inclusion Criteria:
- Participant must be between 12 to 65 years of age (inclusive), at the time of signing
the informed consent.
- Male or Female. Contraceptive use by women should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies.
- Willing to refrain from applying any topical medication products on the target
assessment areas throughout the study until the EoT visit unless necessary to
alleviate intolerable symptoms.
- Willing to refrain taking showers or soaking in a bathtub with soaps and body washes
within 6 hours before TEWL assessments.
- Willing to NOT apply any moisturizers to the areas of the skin that are targeted
assessment areas during the entire study from Day -7 to the EoT visit.
- Willing and able to comply with all clinic visits and study-related procedures.
- Capable of understanding and giving signed informed consent/assent as will be
described in the protocol, which includes compliance with the requirements and
restrictions listed in the informed consent form (ICF) and in this protocol. For
adolescents =12 and <18 years of age a specific ICF must also be signed by the
participant's legally authorized representative.
ATOPIC DERMATITIS PAIENTS ONLY:
- Patients with AD diagnosis according to Hanifin and Rajka criteria at least 1 year
before screening.
- Investigator Global Assessment (IGA) score of =3 at screening (on the 0-4 scale).
- Patients with moderate to severe atopic dermatitis that are eligible to be treated
with dupilumab according to package insert.
- Patients with AD must have active lesions on the upper limbs or lower limbs, with
severity for lesion erythema or edema/papulation =2 at screening on the 0-3 scale of
the ISS.
- Participants should have a non-lesional (normal looking) skin area 4 cm from the edge
of the lesional area. If unable to identify non-lesional skin 4 cm from the lesional
area, it is acceptable to identify normal looking skin as close to the lesion as
possible.
HEALTHY VOLUNTEERS ONLY:
- Age and gender matched to a selected AD patient by study site. Adolescents aged 12 to
17 years will be matched by post puberty status, and adults aged 18 to 65 years will
be matched by age as close as possible within 10 years of age.
- No current or prior dermatologic or systemic condition that could interfere with the
assessments.
Exclusion Criteria:
- Medical conditions
- Previous treatment with dupilumab within 6 months prior to screening.
- Skin conditions other than AD that can confound assessments in the area of TEWL
assessments in the opinion of the investigator (ie, skin atrophy, ichthyosis,
Netherton syndrome, severe photo damage).
- Cracked, crusted, oozing, or bleeding AD lesions in the designated lesional assessment
area leaving insufficient skin that is adequate for TEWL assessments.
- Ocular disorder that in the opinion of the investigator could adversely affect the
individual's risk for study participation. Examples include -but are not limited to-
individuals with a history of active cases of herpes keratitis; Sjogren's syndrome,
keratoconjunctivitis sicca or dry eye syndrome that require daily use of supplemental
lubrication; or individuals with ocular conditions that require the use of ocular
corticosteroids or cyclosporine.
- Systemic AD treatment or phototherapy within 4 weeks of baseline.
- Topical AD treatment within 1 week of baseline. Face and neck may be treated with
topical steroids during the washout period if approved by the investigator.
- Severe prior or concomitant illness(es) that, in the investigator's judgment, would
adversely affect the patient's participation in the study. Examples include, but are
not limited to patients with short life expectancy, patients with uncontrolled
diabetes (hemoglobin A1c =9%), patients with cardiovascular conditions (eg, Class III
or IV cardiac failure according to the New York Heart Association classification),
severe renal conditions (eg, patients on dialysis), hepato-biliary conditions (eg,
Child-Pugh class B or C), neurological conditions (eg, demyelinating diseases), active
major autoimmune diseases (eg, lupus, inflammatory bowel disease, rheumatoid
arthritis, etc), other severe endocrinological, gastrointestinal, metabolic,
pulmonary, psychiatric (known suicidal intentions),lymphatic diseases, or any
illness(es) that resulted in prior or current use of chemotherapy or radiation . The
specific justification for patients excluded under this criterion will be noted in
study documents (chart notes, electronic case report forms [eCRF], screening logs,
etc).
- History of hypersensitivity reaction to tape or adhesives. Prior/concomitant therapy
- Treatment with an investigational drug within 8 weeks or within 5 half-lives (if
known) prior to Day 1, whichever is longer.
- Treatment with live (attenuated) vaccine within 4 weeks before the baseline visit.
Prior/concurrent clinical study experience
- Current participation in another investigational clinical study. Other exclusions
- Individuals accommodated in an institution because of regulatory or legal order;
prisoners or participants who are legally institutionalized
- Participant not suitable for participation, whatever the reason, as judged by the
Investigator, including medical or clinical conditions, or participants potentially at
risk of noncompliance to study procedures
- Participants are employees of the clinical study site or other individuals directly
involved in the conduct of the study, or immediate family members of such individuals
(in conjunction with section 1.61 of the ICH-GCP Ordinance E6)
- Any specific situation during study implementation/course that may raise ethics
considerations
- Sensitivity to any of the study interventions, or components thereof, or drug or other
allergy that, in the opinion of the Investigator, contraindicates participation in the
study
- Planned or anticipated major surgical procedure during the patient's participation in
this study.
- Pregnant or breast-feeding women or were planning to become pregnant or breastfeed
during the subject's participation in this study.
- Women unwilling to use adequate birth control, if of reproductive potential and
sexually active.
- Healthy volunteers with a personal history of an atopic condition.
- Healthy volunteers with use of any topical treatment anywhere except Cetaphil,
Vanicream, or the preferred moisturizer not containing additives on non-targeted skin
areas.
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