Exploratory Study of the Cutaneous Penetration of Biodegradable Polymeric Microparticles in Atopic Dermatitis

• Status: Terminated
• Trial end date: 2017-10-03
• Target enrollment: 0
• Participant gender: All

Summary

This proof of concept study aims to assess in patients suffering from atopic dermatitis if polymeric microparticles reach the pilosebaceous follicles of inflamed skin.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Besancon
• Collaborator: University of Franche-Comté

Criteria

Inclusion Criteria:

• Healthy volunteers:

• Volunteers over 18

• Male volunteers under 65 or women of childbearing age (with a negative pregnancy test obtained at least 3 weeks before inclusion)

• Caucasian volunteers

• Volunteers having never shown any type of skin lesions regardless of its origin especially any allergic skin reactions.

• Volunteers having signed a free and informed consent form

• Volunteers affiliated to a social security system

• Patients:

• Patients over 18

• Male patients under 65 or women of childbearing age (with a negative pregnancy test obtained at least 3 weeks before inclusion)

• Caucasian patients

• Acute phase of atopic dermatitis with a SCORAD between 15 and 40

• Patients suffering from atopic dermatitis skin lesions ≥ 1.5 cm² on the inside of the forearm

• Patients having been treated by class II dermocorticoids with a two-week wash-out prior to inclusion

• Patients having signed a free and informed consent form

• Patients affiliated to a social security system

Exclusion Criteria:

• Participants under 18

• Pregnant or Breastfeeding women

• Post-menopausal women

• Patients having skin lesions adjacent to the selected area

• Patients with complications of atopic dermatitis

• SCORAD <15 or >40

• Patients being treated with a topical or a systemic treatment influencing the skin penetration of the microparticles

• Patients allergics to any component of the formulation

• Patients using cosmetic products on their forearms

• Patients planning to expose themselves to the sun

• Patients with a known immune deficiency

• Patients allergic to any product or device used before, during or after the skin biopsy

• Patients suffering from known wound healing disorders

• Patients with known inherited ou acquired hemostasis disorders

• Patients unable to follow the protocol requirements

• Patients currently involved in another clinical trial (or whose participation has ended less than 2 weeks before inclusion)

• Patients who are not affiliated to a social security system

• Patients in an exclusion period following participation in another clinical trial

• Incapacitated adults

• Participants placed under tutorship or curatorship

• Participants under judicial protection