Phase
Condition
Allergy
Scalp Disorders
Hives (Urticaria)
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject over 18 years of age
Subject able to read, understand and give documented informed consent
Subject willing and able to comply with the protocol requirements for the duration ofthe study
Subject with health insurance coverage according to local regulations
For woman with childbearing potential :
Use of a highly effective method of birth control from at least 1 month prior tostudy enrollment until the last visit
Negative urine pregnancy test at inclusion visit A highly effective method ofbirth controlled is defined as one which results in a low failure rate (i.e. lessthan 1% per year) when used consistently and correctly, such as implants,combined oral contraceptives, intrauterine device, double barrier methods (e.g.condom with spermicide), sexual abstinence or vasectomized partner. Woman with nochildbearing potential is defined as: woman with amenorrhea for at least 12months (without an alternative medical cause); woman who had undergone apermanent sterilization method (eg bilateral tubal occlusion which includes tuballigation procedures, hysterectomy, bilateral salpingectomy, bilateraloophorectomy); or otherwise be incapable of pregnancy.
Subject diagnosed with moderate-to-severe AD, defined as SCORAD≥20 and/or EASI≥7 (Eichenfield et al., 2014)
Subject with AD involvement of 10% (or more) Body Surface Area (BSA) according tocomponent A of SCORAD
Subject with I, II, III or IV skin phototype (according to Fitzpatrick scale)
Subject accepting skin prick-tests and skin biopsies
Subject having a least one non lesional area on the body (off head and neck, feet andhands)
Subject eligible for systemic treatment
Failure, intolerance or contraindication to available systemic treatments (i.e.cyclosporine/methotrexate)
Exclusion
Exclusion Criteria:
Pregnancy or breast-feeding women, or planning to become pregnant or breastfeed duringthe study
Women unwilling to use adequate birth control, if of reproductive potential andsexually active.
Subject currently experiencing or having a history of other concomitant skinconditions that would interfere with evaluation of AD
History of allergic reaction to local anesthetic product
History of wound healing disorders (e.g. hypertrophic scars, keloids)
Subject with known active infection to HBV, HCV or HIV
Subject with known helminth infection
Subject with known blood dyscrasia
Subject having an allergen immunotherapy within 3 months before study
Subject treated by antihistamine 5 days before study. Please note, antihistamineadministered to treat allergic rhino conjunctivitis is allowed after V1.
Subject treated with an investigational drug within 8 weeks or within 5 half-life (ifknown), whichever is longer, before the baseline visit
Subject treated with cyclosporine, methotrexate oral corticosteroids, azathioprine,mycophenolate mofetil, and/or any other systemic immunosuppressor/immunomodulatorwithin 4 weeks before the study
Subject treated by a biologic therapy within 5 half-life before the study
Subject treated with ultraviolet therapy within 4 weeks before study
Subject treated with a live (attenuated) vaccine within 12 weeks before baseline visit
Subject having a planned surgery during the study
Subject presenting clinically significant medical disease that is uncontrolled despitetreatment that is likely, in the opinion of the investigator, to impact patient'sability to participate in the study or to impact the study efficacy or safetyassessments
Subject with any additional condition that, in the opinion of the investigator, mayinterfere with the assessment or put the subject at risk
Linguistic or mentally incapacity to sign the consent form
Subject protect by the law (adult under guardianship, or hospitalized in a public orprivate institution for a reason other than study, or incarcerated)
Subject in an exclusion period from a previous study or who is participating inanother clinical trial
Study Design
Connect with a study center
Service d'Allergologie et Immunologie Clinique - Hôpital Lyon Sud
Pierre-Bénite, 69495
FranceActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.