Baseline Biomarkers and 3D Bioprinted Skin Model in Atopic Dermatitis

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

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

Open for enrollment

Contact information:

Jessica Hafeman

(507) 422-6964

Hafeman.Jessica@mayo.edu

More information

Publications

Publications are currently not available