Actinic Keratosis, Basal Cell Carcinoma, Erysipelas, Herpes Zoster, Impetigo, Melanoma, Molluscum Contagiosum, Squamous Cell Carcinoma, Tinea, Warts
Conditions
Keywords
melanoma, non-melanoma skin cancer, mole, app, cliccailneo
Brief summary
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.
Interventions
PROCEDUREScreening
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).
DEVICETele-dermatology
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.
Sponsors
Centro Studi Gised
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Subjects currently working at the Local Health Authority of the province of Bergamo
Exclusion criteria
* Subjects who are not able to use the tele-dermatology system or who have no access to the website or the specific app.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative incidence of at least one non-widespread skin lesion identified and clinically confirmed as suspected / highly suspected | Two years |
Secondary
| Measure | Time frame |
|---|---|
| Agreement between the tele-dermatology system and the direct dermatological visit as assessed by Cohen's kappa (within the experimental arm). | 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). | Within the two years study period |
| Proportion of subjects who have at least one anticipated follow-up visit (within the comparator arm). | Within the two years study period |
| Proportion of subjects with at least one missed scheduled visit at follow-up(within the comparator arm). | Within the two years study period |
Countries
Italy
Outcome results
None listed