Virtual Clinical Trials in Atopic Dermatitis

Eczema is the most prevalent skin disease. It has a high impact on the quality of life of the sufferers. Prurit is a very bothersome symptom that can become an obsession and cause a vicious circle. Lesions can also have a high impact on self-esteem, in particular when they affect the face or other visible parts of the body. The prevalence of eczema has doubled within the last 3 decades.

Cause is unknown and the search for triggers is a key to identifying sources and eliminating them. Healint provides tools to help patients identify their triggers and treatments. No single treatment can work on every patient and our goal is to propose a personalized treatment to each, based on their symptomatology. One way to help patients is also to speed up new treatment approvals.

This is also a step in which Healint plays a role, by conducting virtual clinical trials for the assessment of new treatments. We have developed tools that allow the clinician to rate the severity of the disease using the scales most commonly used for this disease. We also offer the possibility for patients to self-rate their symptoms in order to assess a treatment efficacy.

Evaluating the characteristics of a lesion is often subject to a bias. In order to reduce the risk of misinterpretation, we collect pictures that are assessed centrally by two independent trained evaluators who are blind to the treatment. In parallel, we use AI-based image recognition to assess symptoms. This dramatically increases the quality of the data, reduces the background noise and thus the number of patients needed for each trial. This generates accelerated study results and several months saved and thus an earlier market reach.

EASI

(ClinRO)

The Eczema Area and Severity Index is a validated scoring system that grades the physical signs of atopic dermatitis/eczema. It is the most commonly used as a primary endpoint in clinical trials. It’s actually recommended to use it in every clinical trial since 2013, after the HOME-III meeting (Harmonising Outcome Measures for Eczema). The score is based on a severity value of 0 to 3, for 4 dimensions (erythema, edema/population, excoriation and lichenifaction) on 4 zones of  the body (head and neck, trunk, upper limbs, lower limbs), taking into account the percentage of each zone affected by eczema. The complex algorithm is calculated automatically by our software to reduce human error.

Pruritus NRS

(PRO)

Employed in all clinical trials, as primary or secondary endpoint, the pruritus Numerical Rating Scale is used to score the subjective symptom of itching. It is an 11-level scale from 0 (no itch at all) to 10 (worst imaginable itch). It can be used to assess the average daily itch, the worst daily itch, or it can cover a different recall time, all depending on the protocol. 

DLQI

(PRO)

The Dermatology Life Quality Index is not specific to eczema, but is used to assess the impact of a skin disease on a sufferer. Most of the time it is only a secondary endpoint of clinical trials. At Healint we think that the patient well being is more important than mere visible symptoms.

SCORAD

(ClinRO/PRO)

The SCORAD (SCORing Atopic Dermatitis) is a tool used in clinical research that was developed to standardize the evaluation of the extent and severity of Atopic Dermatitis. It assesses three components of the disease: the affected body surface area, severity of clinical signs (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness), and symptoms (itch, sleeplessness). A patient reported version of the SCORAD is also available. 

We recently conducted a study on atopic dermatitis. In this study, among others, we ran the pain NRS (Numerical Rating scale). The baseline was rather low for people with Eczema, as compared to what we have observed in other conditions. When asked to rate the pain intensity over the last 24 hours, patients reported an average of 4.94 on this scale from 0 to 10. The interesting fact was that when asked to rate their pain over 1 week, 1 month or 1 year, pain intensity was higher and higher. For 1 year recall, the average reached 6.02 on this scale. This difference of 1.06 point was significant.

The breakdown of pain level is interesting to analyse:

The graph on the right shows a decrease of the lower pain values (0 to 4) and an increase of higher pain values (7-10) when the duration of recall increases. When asked to recall the last 24 hours, lower pain values are reported by 41% of respondents, while that percentage drops to 20% when asked to recall a longer time period of 12 months.

Similarly, higher pain values are reported by 34% of the respondents when asked to recall the last 24 hours, which increases to 45% when asked to recall the last 12 months. This could mean that a person perceives their long-term condition as more painful than a short-term attack.

Conclusion

Overestimation of pain at recall is frequently reported in scientific literature. Our findings suggest that the reason for this is that the recall of pain intensity increases over time, thus leading to a perceived higher pain intensity the longer the recall period. It is thus important to report pain level daily rather than over time when testing the efficacy of new relief methods for your conditions.