Mobile health technologies in an interventional hybrid study on actinic keratosis: Results from an early phase randomized controlled trial investigating the safety and efficacy of a cytosolic phospholipase A2 inhibitor gel in photodamaged skin.

Hybrid trials are a new trend in dermatological research that leverage mobile health technologies to decentralize a subset of clinical trial elements and thereby reduce the number of in-clinic visits. In a Phase I/IIa randomized controlled hybrid trial, the safety and efficacy of an anti-proliferative and anti-inflammatory drug inhibiting cytosolic phospholipase A2 (AVX001) was tested using 1%, 3% or vehicle gel in 60 patients with actinic keratosis (AK) and assessed in-clinic as well as remotely. Over the course of 12 weeks, patients were assessed in-clinic at baseline, end of treatment (EOT) and end of study (EOS), as well as 9 times remotely on a weekly to biweekly basis.

Rapid Web-Based Recruitment of Patients With Psoriasis: Multinational Cohort Study.

Background: Wide-ranging patient recruitment not restricted to the location of the investigator will provide a better representation of the patient population in clinical studies.

Objective: Our goal was to assess the feasibility of a broad web-based recruitment strategy in an 8-week observational study of 500 study participants with psoriasis and healthy controls from locations remote from the investigator and to assess the cost associated with each participant.

Methods: A decentralized team in Denmark recruited patients with psoriasis and healthy controls using Google and Facebook advertisements and posts to Facebook groups.

The Copenhagen Actinic Keratosis Study (COAKS). A decentralised clinical trial to evaluate tolerability, safety and efficacy of daily field-directed topical treatment with cytosolic phospholipase A inhibitor, AVX001, in participants with actinic keratosis: protocol for a randomised controlled phase I/IIa trial.

Introduction: Actinic keratosis (AK) is the most common precancerous skin condition caused by long-term UV exposure. Given the high recurrence rate of 15%-53%, identifying safe and effective treatment options is warranted. AVX001, a cytosolic phospholipase Aα (cPLAα) enzyme inhibitor, is a novel anti-inflammatory drug for field-directed, self-administered, topical therapy of AK.

Mild to moderate atopic dermatitis severity can be reliably assessed using smartphone-photographs taken by the patient at home: A validation study.

Background: The use of photographs to diagnose and monitor skin diseases is gaining ground.

Objectives: To investigate the validity and reliability of photographic assessments of atopic dermatitis (AD) severity.

Methods: AD severity was evaluated in the clinic by two assessors using the Eczema Area and Severity Index (EASI), SCOring Atopic Dermatitis (SCORAD), and Investigator's Global Assessment (IGA).

Exploring Decentralized Glucose and Behaviometric Monitoring of Persons with Type 2 Diabetes in the Setting of a Clinical Trial.

Background: Clinical trials often suffer from recruitment barriers and poor adherence, which increases costs and affects trial outcomes.

Objective: To investigate the feasibility of Decentralized Clinical Trial (DCT) design elements to recruit, enroll, and engage patients with type 2 diabetes mellitus (T2DM).

Methods: Patients with T2DM were recruited through a pharmacy and online recruitment using advert on Facebook, to 3 weeks monitoring of glucose and behaviometric parameters.

Remote Rating of Atopic Dermatitis Severity Using Photo-Based Assessments: Proof-of-Concept and Reliability Evaluation.

Background: Digital imaging of dermatological patients is a novel approach to remote assessment and has recently become more relevant since telehealth and remote decentralized clinical trials are gaining ground.

Objective: We aimed to investigate whether photographs taken by a smartphone are of adequate quality to allow severity assessments to be made and to explore the usefulness of an established atopic dermatitis severity assessment instrument on photograph evaluation.

Methods: During scheduled visits in a previously published study, the investigating doctor evaluated the severity of atopic dermatitis using the Scoring AD (SCORAD) index and took photographs of the most representative lesions (target lesions) with both a smartphone and a digital single-lens reflex camera (DSLR).

High adherence and low dropout rate in a virtual clinical study of atopic dermatitis through weekly reward-based personalized genetic lifestyle reports.

Introduction: Clinical trials often suffer from significant recruitment barriers, poor adherence, and dropouts, which increase costs and negatively affect trial outcomes. The aim of this study was to examine whether making it virtual and reward-based would enable nationwide recruitment, identify patients with variable disease severity, achieve high adherence, and reduce dropouts.

Methods: In a siteless, virtual feasibility study, individuals with atopic dermatitis (AD) were recruited online.