Periodic Reporting for period 2 - ScanZ (Digital acne assessment tool enabling acne diagnosis in cost and time efficient way)
Berichtszeitraum: 2017-09-01 bis 2019-02-28
Oral isotretinoin is a highly effective therapy for acne but is currently only available via an appropriately trained dermatologist and as a hospital only prescription due to potential serious adverse effects including teratogenicity and concerns about a causal relationship between the drug and depression / suicidal ideation. Female patients on isotretinoin require monthly follow up as part of a pregnancy prevention programme. More cost-effective care pathways and avoidance of waste are priorities for health service providers. This is all compounded by the fact that the majority of dermatologists use subjective, typically administrative methods of classifying acne lesions. Without objective, quantified data, the treatments are more costly. Severe acne is generally treated with strong drugs, e.g. tetracycline, that can induce serious side effect such as skin irritation, burning or redness, peeling, scaling or discoloration of the skin, increased tendency to sunburn, upset stomach, dizziness, light-headedness or even fetal malformations for pregnant women.
Neglecting to take care of acne may lead to permanent physical effects, like scarring or disfigurement that can also accompany long-lasting psychosocial effects: depression, anxiety, poor self-image and poor self-esteem, or even suicidality. Recent studies had proved that 56% of acne sufferers are more likely to have feelings of isolation and loneliness, 5% of acne patients have considered suicide and 5% have higher unemployment rate compared to adults without acne.
mySkin aims to significantly contribute to a sustainable and cost efficient healthcare system by automating and simplifying the assessment of acne severity. In the PH2 project mySkin seeks to clinically validate, qualify and certify the medical device through a large-scale multicentre medical trial and to develop a high quality and large scale database. The expected outcome of the project is to bring a medically certified MD device to the European market at the end of PH2.
From months 12-30 of the project the SME beneficiary focused on product development: a) hardware development and pro-production prototypes, b) preparation of the software for the evaluation of ScanZ in a clinical trial, c) regulatory filings, preparation of the SME beneficiary for implementation of the Quality Management System (QMS), and d) development of the healthcare economic strategy to assess the impact of ScanZ. Two in-person workshops and training visits have been successfully conducted. 2 deliverables have been successfully achieved. Due to technical and production delays in delivering ScanZ units for the clinical trials as well as hardware complications (identified as risks #1 and #2 in the original grant), the final months were dedicated to restructuring the software portion of ScanZ to mitigate the risks and complete the project within the extended timeline. The last months of the project were also dedicated to restructuring the regulatory approach to ScanZ as a class IIa medical device."
By the end of the project, ScanZ will have implemented the first step to the overall platform which is the Hospital information system, a class IIA device that enables nurse practitioners to conduct follow-ups of Isotretinoin patients using a fully digital approach.