Open label exploratory study to evaluate the effect of dupilumab on skin barrier function in patients with moderate to severe atopic dermatitis - BALISTAD

Sanofi-Aventis Recherche & Développement0 个研究点开始时间: 2021年8月17日最近更新: 2021年8月24日

适应症

试验速览

暂无简介。

•- Participant must be between 12 to 65 years of age (inclusive), at the time of signing the informed consent.
•Atopic dermatitis patients:
•- Male or female patients.
•- Patients with AD diagnosis according to Hanifin and Rajka criteria at least 1 year before screening.
•- 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 product monograph
•- 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:
•- Age and gender matched to a selected AD patient. 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..
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 24
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 24
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- 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.
•- Healthy volunteers with a personal history of an atopic condition.

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