Surfing the Three Waves of AI in Clinical Skin Imaging with Scarletred® Vision

Artificial intelligence is rapidly transforming clinical research, and dermatology is no exception. Over the past decade, clinical skin imaging has evolved from simple photographic documentation to standardized, data-driven, and AI-assisted analysis. However, many clinical trials still rely on fragmented imaging workflows, subjective visual assessments, and hardware-dependent solutions that limit scalability and data comparability.

At SCARLETRED, we observe that organizations adopt AI in distinct stages of maturity. Some focus primarily on improving operational efficiency, others already use imaging data for quantitative analysis, and a smaller group is moving toward fully AI-assisted clinical scoring. We describe this evolution as the Three Waves of AI in Clinical Skin Imaging. Our framework helps Sponsors, CROs, and investigators to assess where they currently stand and understand how to unlock the full potential of AI-enabled skin drug research via Scarletred® Vision.

The key question is very simple:

Are you already riding the AI wave — and if so, which wave are you on?

Efficiency, quality, and transformation in clinical skin imaging trials

In dermatology, the impact of Artificial Intelligence depends on one key requirement: standardized, high-precision skin imaging data. Without reproducible images and objective measurements, AI cannot unfold its potential.

Scarletred® Vision was developed to address this challenge. As a modular, smartphone-based digital skin imaging platform, it enables clinical research partners to navigate the Three Waves of AI in clinical skin imaging: efficiency, quality, and transformation.

From subjective assessment to standardized digital imaging

Clinical skin assessment has traditionally relied on visual examination and manual documentation. These methods can be time-consuming and difficult to standardize, and may result in variability between investigators, study sites, and devices.  

Hardware-based imaging systems do not always deliver consistent, reproducible results. This can limit the reliability of longitudinal evaluations and reduce the quality and usability of data for retrospective analyses.

At the same time, regulatory approval and real-world evidence data generation increasingly require objective, standardized documentation of skin conditions and treatment effects.

A modular platform for clinical skin imaging

Scarletred® Vision is designed as a modular Software-as-a-Service (SaaS) platform with three functional packages:

1. Imaging SaaS for standardized skin documentation and dataset management
2. Analysis SaaS for quantitative measurement of skin parameters
3. AI SaaS for automated disease severity scoring

The Scarletred® Vision Imaging SaaS forms the foundation of our solution. Analysis and AI functionalities can be activated at any stage of a clinical trial, enabling a gradual expansion of capabilities.

The Three Waves of AI in clinical skin imaging

Wave 1: Efficiency – scalable clinical imaging

The first wave of AI focuses on optimizing processes. By standardizing image acquisition and documentation, Scarletred® Vision reduces manual effort and operational complexity in clinical trials.

Imaging workflows become faster, more scalable, and easier to manage across multiple sites.  

Remote monitoring decreases on-site activities and supports decentralized trial designs. Our AI-assisted image calibration provides distance and angle guidance, and the platform enables data comparison before and after the study.

Wave 2: Quality – images as quantitative data

The second wave of AI focuses on quantitative analysis. Scarletred® Vision Analysis SaaS provides clinically validated quantification of key skin parameters, including erythema, pigmentation and pigment changes, texture, lesion area, and 2D/3D metrics.

With the support of AI, these quantitative imaging markers allow precise analysis and monitoring of treatment effects over time. All images are stored securely and chronologically, which is why real-time or retrospective analysis remains possible even when advanced analysis capabilities are activated at a later stage.

Wave 3: Transformation – AI-driven scoring

The third wave of AI transforms clinical skin assessment.

Our AI Agent ARORA® AI integrates multiple quantitative skin parameters to generate automated disease severity scores - aligning with dermatological Gold Standard scoring systems.  

This standardizes data-driven scoring across trial sites and reduces variability from subjective assessments.

By combining standardized image acquisition, quantitative biomarkers, and algorithm-based scoring, clinical skin imaging shifts from descriptive documentation to a structured, reproducible, and scalable method of objective assessment.

Changing clinical skin imaging at its core

Scarletred® Vision addresses key challenges in clinical skin imaging:

1. Variability is reduced via standardized, device-agnostic imaging without hardware dependency.
2. Inefficiency is minimized by automated documentation and analysis.
3. Subjectivity is reduced with reproducible imaging and quantitative markers.
4. Data comparability is increased through a centralized data overview via the web platform and mobile app.

As a result, clinical skin imaging trials become more standardized, reproducible, and data-driven across all sites and study phases.  

However, our system consistently ensures that doctors remain in control: Our AI Agent serves as decision support. The primary and ultimate decisive authority stays entirely with doctors and physicians.  

Scarletred® Vision enables partners to surf all Three Waves of AI - efficiency, quality, and transformation - building a strong foundation for AI-enabled dermatological research.

Standardized Imaging with Scarletred® Vision

Scarletred® Vision Imaging SaaS is a CE Class 1m certified Software as a Medical Device (SaMD), ensuring consistency and comparability across clinical trials.  

It is smartphone-based (iOS and Android) and requires no additional hardware. Using the Scarletred® Vision mobile app, users capture skin images guided by standardized protocols.  

A calibration patch - the Scarletred® Skin Patch - is placed on healthy skin near the target area to enable color and intensity calibration and to guide distance and perspective. Key imaging parameters such as lightning, angle, distance, framing, and skin ethnicity are standardized.  

In addition, anatomical body areas can be tagged, and structured questionnaires (ePRO, eCOA, DLQI) capture disease characteristics, symptoms, quality of life and patient diaries as well as clinical outcomes.

Each patient uses an anonymized QR code, ensuring data privacy. All data is securely stored and monitored on the Scarletred® Vision web platform, enabling remote access and longitudinal tracking of treatment effects.