A Prospective, Observational Study of Clinician and Patient-reported Outcomes in Patients With Dermatological Conditions

Launched by OM1, INC. · Oct 7, 2021

Keywords

ClinConnect Summary

ClinPRO-DERM is a multi-center, observational study that will follow adults with one of five skin conditions—alopecia areata, atopic dermatitis (eczema), hidradenitis suppurativa, psoriasis, or vitiligo—for up to two years. Researchers will collect information from doctors and from patients about how active the disease is, how symptoms affect daily life, and overall quality of life. The goal is to understand how these conditions change over time in real-world care and what factors are linked to better or worse outcomes.

If you’re eligible, you would be adults 18 or older who can read English and have a confirmed diagnosis of one of the study conditions. You’d need a smartphone or internet-enabled device to complete periodic patient surveys and be willing to participate for up to two years. This is not a drug trial—there are no treatments given by the study itself, just observation during usual care. The study is currently enrolling by invitation and is based in places like OM1 in Boston, with results expected around 2026.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult (defined as the age of majority in their state of residence or older) at enrollment
• • Able to read and communicate in English
• • Have a smart phone or other internet enabled device capable of PRO data collection
• • Diagnosed with a qualifying, clinically confirmed, diagnosis of a study condition in the judgement of the treating physician at presentation
• • Willing and able to provide informed consent
• • Willing to participate in the collection of patient-reported outcomes for up to two years
• Exclusion Criteria:
• • Current (or planned) participation in an interventional clinical trial where treatment and/or management of any of the study conditions is being dictated by a protocol.
• • Patient is not expected to be actively followed (i.e., seen at least annually as part of routine care) at the site for the duration of the follow-up period.