The purpose of this study is to demonstrate the validity and utility of a tele-dermatology system in the midterm periodic screening of non-widespread skin lesions of recent onset or for which a specialized early classification is deemed to change the prognosis - including precancerous skin lesions as well as melanoma and non-melanoma skin cancers - compared to control visits at fixed follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
461
The screening visit consists in a general dermatological examination of the subject, with special focus on the onset of the following skin diseases during the follow-up period: 1. bacterial skin infections - pyoderma - or viral (erysipelas, impetigo, herpes zoster, molluscum contagiosum, viral warts); 2. fungal skin infections (tinea corporis, cruris, pedis); 3. pigmented tumors (melanoma); 4. non-melanocytic tumors (actinic keratoses, basal cell or squamous cell carcinoma).
The system consists in a simple web-based/smartphone application through which subjects can send pictures of recently onset non-widespread skin lesions with special focus on the following diseases: 1. bacterial skin infections - pyoderma - or viral (erysipelas, impetigo, herpes zoster, molluscum contagiosum, viral warts); 2. fungal skin infections (tinea corporis, cruris, pedis); 3. pigmented tumors (melanoma); 4. non-melanocytic tumors (actinic keratoses, basal cell or squamous cell carcinoma). A dermatology will judge online pictures based on a standard scale. Each subject who will use the system will be also seen by routine clinical visit to confirm the online diagnosis. Subjects who will not send any picture will be seen for a dermatological examination at the end of each year.
Local Health Authority (ATS)
Bergamo, Italy
Cumulative incidence of at least one non-widespread skin lesion identified and clinically confirmed as suspected / highly suspected
Time frame: Two years
Agreement between the tele-dermatology system and the direct dermatological visit as assessed by Cohen's kappa (within the experimental arm).
Time frame: Within the two years study period
Cumulative incidence of at least one non-widespread skin lesion identified as suspected / highly suspected among subjects who did not use the tele-dermatology system (within the experimental arm).
Time frame: Within the two years study period
Proportion of subjects who have at least one anticipated follow-up visit (within the comparator arm).
Time frame: Within the two years study period
Proportion of subjects with at least one missed scheduled visit at follow-up(within the comparator arm).
Time frame: Within the two years study period
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