Dermatology clinical trials
Dermatology is a highly subjective therapeutic area, and many primary endpoint assessments require a
clinician to evaluate skin lesions. Clinical outcome assessments (COAs) and advanced imaging technology, coupled with clinical training and engagement with patients on reliable reporting all contribute to quality dermatological studies.
Clinical outcome assessments (COA) are a key endpoint in most dermatology studies, and regulatory agencies and best practices strongly recommend the use of electronic data collection to improve compliance and data accuracy.
In addition, proper training for patients, caregivers, and site staff is required to generate quality outcome data. Our eCOA solution is designed for efficiency and reducing inter- and intra-rater variability.
For clinician-reported outcomes (ClinROs), i.e., PASI, EASI, IGA, SCORAD:
- Automatic scoring for reducing site burden and minimizing error
- Built in logic for faster more efficient data entry
- Reference images of severity scores for more consistent scoring
- Rater training for standardizing assessment evaluation methods
For patient-reported outcomes (PROs):
- Alarms to remind participants to complete symptom diaries (i.e., pain, itch)
- Rapid deployment of commonly used PRO assessments such as the Dermatology Life Quality Index (DLQI) and patient diaries such as Worst Itch Numeric Rating Scale (WI-NRS)
- Participant training to reduce placebo effect, increase accuracy of PRO reporting, and increase compliance
Clario also offers a solution that combines eCOA with photo and audio endpoint capture. Clinicians can track progress visually over time to measure treatment efficacy more accurately. The single secure device is dual-purpose for both ePRO assessments and photo capture, improving patient compliance. And the solution not only reduces site visits to keep patients safe but works in hybrid and virtual modalities.
eCOA Multimedia is ideal for dermatology trials. The solution is integrated into the normal eCOA workflow. The camera automatically activates along with instructions for questions that require an image. The photo is linked to the patient’s eCOA assessment and submitted automatically and securely to the study database. The image is then processed securely, de-identified, and analyzed using Clario’s market-leading imaging capabilities.
Clario’s imaging technology harnesses the power of artificial intelligence and an expert team of scientists to offer an advanced, flexible solution for your dermatology studies. With a cloud-based platform, Clario’s imaging management platform allows for easy access and complete visibility into data throughout the course of your dermatology trial.
Dermatology use cases include:
- Capturing lesions and counts
- Acne counts
- Monitoring skin/nail progression
- Skin malignancy
- Cross-section of tissue structures
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