ErysipelasNCT02902822
Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo
A study testing Screening and Tele-dermatology in people with Erysipelas and Impetigo, run by Centro Studi Gised at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Erysipelas, Impetigo, Herpes Zoster
- What is being tested?
- Screening and Tele-dermatology
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 461 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2016to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects currently working at the Local Health Authority of the province of Bergamo
Who cannot join
- Subjects who are not able to use the tele-dermatology system or who have no access to the website or the specific app.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tele-dermatology of Skin Cancer: a Randomized Trial Comparing Remote Assessment With Conventional Visits in a Cohort of Local Health Authority Employees in the Province of Bergamo (the Shoot the Mole Study)
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.
- Conditions
- Erysipelas, Impetigo, Herpes Zoster, Molluscum Contagiosum, Warts, Tinea
- Being tested
- Screening, Tele-dermatology
- Keywords
- melanoma, non-melanoma skin cancer, mole, app, cliccailneo
- Medical subject headings
- Erysipelas, Impetigo, Herpes Zoster, Molluscum Contagiosum, Warts, Tinea, Melanoma, Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreeningProcedure or surgery
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:
- bacterial skin infections - pyoderma - or viral (erysipelas, impetigo, herpes zoster, molluscum contagiosum, viral warts);
- fungal skin infections (tinea corporis, cruris, pedis);
- pigmented tumors (melanoma);
- non-melanocytic tumors (actinic keratoses, basal cell or squamous cell carcinoma).
Tele-dermatologyDevice
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:
- bacterial skin infections - pyoderma - or viral (erysipelas, impetigo, herpes zoster, molluscum contagiosum, viral warts);
- fungal skin infections (tinea corporis, cruris, pedis);
- pigmented tumors (melanoma);
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Screening | Active comparator | This arm includes all subjects randomized to regular dermatological follow-up visits on annual basis. Receives: Procedure: Screening |
| Tele-dermatology | Experimental | This arm includes all subjects randomized to the use of a tele-dermatology system for the evaluation of newly onset non-widespread skin lesions. Receives: Device: Tele-dermatology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of at least one non-widespread skin lesion identified and clinically confirmed as suspected / highly suspected
Measured: Two years
Secondary outcomes (4)
Agreement between the tele-dermatology system and the direct dermatological visit as assessed by Cohen's kappa (within the experimental arm).
Measured: 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).
Measured: Within the two years study period
Proportion of subjects who have at least one anticipated follow-up visit (within the comparator arm).
Measured: Within the two years study period
Proportion of subjects with at least one missed scheduled visit at follow-up(within the comparator arm).
Measured: Within the two years study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErysipelasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Studi Gised
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luigi Naldi, MD, Principal investigator, Centro Studi Gised
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902822
- Sponsor's protocol ID
- CLICCAILNEO_2
- Status last verified
- May 2019
- First submitted
- 8 Sep 2016
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-dermatology of Skin Cancer: a Randomized Trial Comparing Remote Assessment With Conventional Visits in a Cohort of Local Health Authority Employees in the Province of Bergamo (the Shoot the Mole Study)
- ClinicalTrials.gov ID
- NCT02902822
- Acronym / sponsor ID
- CLICCAILNEO_2
- Conditions
- Erysipelas, Impetigo, Herpes Zoster, Molluscum Contagiosum, Warts, Tinea
- Keywords
- melanoma, non-melanoma skin cancer, mole, app, cliccailneo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- Centro Studi GisedUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening | Active comparator | Procedure: ScreeningThis arm includes all subjects randomized to regular dermatological follow-up visits on annual basis. |
| Tele-dermatology | Experimental | Device: Tele-dermatologyThis arm includes all subjects randomized to the use of a tele-dermatology system for the evaluation of newly onset non-widespread skin lesions. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects currently working at the Local Health Authority of the province of Bergamo
Key exclusion criteria (1 listed)
- Subjects who are not able to use the tele-dermatology system or who have no access to the website or the specific app.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScreeningThe 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). | Procedure or surgery | Screening |
| Tele-dermatologyThe 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. | Device | Tele-dermatology |
Primary outcome
Cumulative incidence of at least one non-widespread skin lesion identified and clinically confirmed as suspected / highly suspected
Time frame: Two years
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Naldi, MD principal investigator
Centro Studi Gised
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening and Tele-dermatology in people with Erysipelas and Impetigo, run by Centro Studi Gised at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of at least one non-widespread skin lesion identified and clinically confirmed as suspected / highly suspected (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2019.