Baseline Biomarkers and 3D Bioprinted Skin Model in Atopic Dermatitis

Overview

Acerca de este estudio

The purpose of thisstudy is to define the standard clinical features of atopic dermatitis, or eczema, a skin condition that affects many people.  

Elegibilidad para participar

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Male and female adults aged ≥ 18 years (at the screening visit) with capacity to consent.
  • Diagnosis of moderate-to-severe Atopic Dermatitis (AD) as defined by the Hanifin and Rajka (1980) criteria.
  • AD duration of at least 3 months.
  • IGA score of 2 to 3 at the screening visit.
  • Treatment naïve and/or willing to pursue 30-day wash-out period if they are using topical medications, oral medications, or injectable medications.
  • For participants who sign photography consent, at least 1 target lesion that measures at least 5 cm2 at the screening visit. The target lesion must be representative of the participant's disease state but not located on the hands, feet, genitalia, face, scalp, or intertriginous areas.

Exclusion Criteria:

  • Unstable history of atopic dermatitis (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks before baseline/visit 0.
  • Disease history concerns, i.e., lymphoma, immunodeficiency, chronic infections such as HIV, hepatitis, or tuberculosis, dialysis, and/or history of skin cancer within 5 years.
  • Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline/visit 0.
  • Active acute bacterial, fungal, or viral skin infection (e.g., herpes simplex, herpes zoster, chicken pox, clinically infected AD, impetigo) within 1 week before the baseline/visit 0.
  • Insufficient area of uninvolved (control) skin.
  • Relative contraindications to skin biopsy (e.g., serum platelets < 10; allergy to lidocaine).
  • Atopic dermatitis exclusive to areas of the hands, feet, face, scalp, intertriginous areas, or genitalia.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/10/23. Questions regarding updates should be directed to the study team contact.

Ubicaciones participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Ubicación de Mayo Clinic Estado Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Saranya Wyles, M.D., Ph.D.

Inscripción cerrada

Contact information:

Jessica Hafeman

(507) 422-6964

Hafeman.Jessica@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20549899

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