Skin LesionNCT02740257
Smartphone Application to Detect Skin Lesions
An observational study of Skin Lesion, run by Northwestern University at 1 site in United States.
Trial summary
The primary objective of Part One of this study is to determine the sensitivity of an automated total body digital photography (TBDP) app to detect color and size changes in the human skin, and whether a new lesion has arisen. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Lesion
- What is being tested?
- Photos
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 2 Sep 2022
- Phase
- Observational
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with various skin types (Fitzpatrick I-IV)
Who may be able to join
- Males and females age 18 - 85.
- Subjects with the following skin types:
- Always burns, never tans or
- Burns easily, then develops light tan or
- Burns moderately, then develops light tan or
- Burns minimally rarely, then develops moderate tan.
Show all 11Show fewer
- Subjects who deny prior skin reactions to washable markers.
- Subjects who have natural skin markings on at least 3 areas of their body.
- Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator in English.
- Subjects are able to complete the study procedures.
- Subjects are willing to have digital photos taken of them.
Who cannot join
- Subjects who have a history of skin disease (eg. vitiligo, psoriasis)
- Subjects with the following skin types:
- Never burns, always develops a dark tan or
- Never burns, no noticeable change in appearance.
- Part Two (only):
- H] Subjects must be high risk. High risk is defined as subjects with conditions including, but not limited to: dysplastic nevus syndrome, previous history of melanoma/non-melanoma skin cancer, fair skin, >16 nevi, family history of melanoma, immunosuppressed status I] Subjects must have an iPhone 4S or newer, or an iPad Air 2, iPad Mini 4 or iPad Pro in order to download and use the application and take photographs of high enough quality for the physician to analyze if needed.
Show all 12Show fewer
- J] Subjects must have someone who is able to take photos of the subject every month. The designated individual may or may not be present at the initial encounter.
- 4.2 Exclusion Criteria A] Subjects who have a history of skin disease (eg. vitiligo, psoriasis)
- B] Subjects with the following skin types:
- Never burns, always develops a dark tan or
- Never burns, no noticeable change in appearance. Part Two (only) C] Subjects without the appropriate devices for app download. The appropriate devices are iPhone 4s or newer, or iPad Air 2, iPad Mini 4 or iPad Pro.
- D] Subjects who do not have someone who is capable of taking photos of the subject every month.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: Skin Lesion Detection With Novel Total Body Digital Photography Smartphone Application
The primary objective of Part One of this study is to determine the sensitivity of an automated total body digital photography (TBDP) app to detect color and size changes in the human skin, and whether a new lesion has arisen.
The primary objective of Part Two is to test the sensitivity and specificity as well as feasibility of field use of an automated TBDP app to detect pigmented and non-pigmented skin lesions in high risk populations.
Read the detailed description
SkinIO is an early-stage healthcare IT company specializing in education, early detection, and prevention of skin cancer. This study will utilize their product, skinIO, an enhanced full-body skin cancer screening system that works on mobile devices and tablets to track changes in skin over time without any additional imaging hardware. skinIO enables dermatology staff to photograph high-risk patients in 13 medical photography poses to quickly capture full-body skin surfaces at multiple resolutions using a mobile device. These images are automatically uploaded to a HIPAA-compliant server environment where they will be rapidly processed to detect any spots, lesions, and moles. Dermatologists will then be able to annotate these images and flag specific images for follow-up every month.
In order to assess whether or not the software will accurately detect spot changes, the investigators will test the product on a sample of volunteer subjects.
Part One:
The study population will undergo one study visit. This visit will include 2 sets of photos taken by the research team after the collection of a small amount of identifying and contact information for each subject. There will be an initial 3-5 photographs taken of areas of the body that have at least 3 natural or artificial skin markings (ie. moles, angiomas, scars, keloids, seborrheic keratosis, small tattoos, etc). These markings will allow the app to calculate the parameters of any original lesions, and thereby more accurately detect new markings or changes based on these calculations. Once the original photographs are taken, one of each individual's original skin marking will be enhanced/enlarged with a marking pen, as well as 3- 5 new marks added to the skin. A Sharpie brush tip permanent marker will be utilized to make the new skin markings. These markers have been AP certified to be non-toxic. The following colors have been chosen: orange, black, brown, red, blue, purple, yellow and pink. A second photograph will be taken of the same areas of the body chosen for initial photographs to determine if the application could detect the changes. This group will not have their images sent to a dermatologist for evaluation, as they are artificially produced.
Part Two:
In order to test the sensitivity and feasibility of field of use of the TBDP app, a second convenience sample of patients will be recruited. Recruitment will be done in waiting rooms with the attending physician's consent. If needed, recruitment will be done outside of the waiting room in the form of flyers, website and e-mail announcements. This population will consist of patients with known high risk to have new/changing lesions, and who fall within the Fitzpatrick skin types I-IV. High risk patients include, but are not limited to, those with dysplastic nevus syndrome, previous history of melanoma/non-melanoma skin cancer, fair skin, >16 nevi, family history of melanoma, and/or immunosuppressed status. The first photography session will be taken by the research team in all 13 projections. Each projection corresponds to each body area that will be photographed to ensure total body photography. After the first visit, the patient will be instructed to take photographs every month for 12 months using the TBDP app on their smart phone or tablet, and have follow-up research appointments every 6 months. The patient will be provided a user guide with written instructions for application use. The TBDP app has a built-in reminder system for the patient. Any changes detected by the app will be stored on the research team's database. Standard of care will be followed for any new/changing lesions. Patients will be recommended to have a follow-up appointment with their dermatologist, within 2 weeks. No procedures will be completed by the research team, and a physician will not be seeing the patients during their research appointments. During these visits, the research team will compare the photographs taken by the TBDP app to the patient's skin to see how sensitive the app is. Patients will continue their regular office visits at 6 months and/or 12 months as per standard of care for high risk patients. The research team will use information from chart reviews for assessment of the outcome for new or changing lesions.
- Conditions
- Skin Lesion
- Being tested
- Photos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotosOther
Photos will be taken of skin lesion markings using a smart phone or tablet
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Artificial Lesions | Photos will be taken of skin lesion markings using a smartphone Receives: Other: Photos | |
| Group 2 high risk | A convenience sample of patients will be recruited. This population will consist of patients with known high risk to have new/changing lesions, and who fall within the Fitzpatrick skin types I-IV. High risk patients include, but are not limited to, those with dysplastic nevus syndrome, previous history of melanoma/non-melanoma skin cancer, fair skin, >16 nevi, family history of melanoma, and/or immunosuppressed status. The first photography session will be taken by the research team in all 13 projections. After the first visit, the patient will be instructed to take photographs every month for 12 months using the TBDP app on their smart phone or tablet, and have follow-up research appointments every 6 months. Receives: Other: Photos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of an automated total body digital photography (TBDP)
We will assess whether or not the photography software can accurately detect spot changes. We will test the product on a sample of volunteer subjects. The study population will undergo one study visit and will include 2 sets of photos. There will be an initial 3-5 photographs taken of areas of the body that have at least 3 natural or artificial skin markings. These markings will allow the app to calculate the parameters of any original lesions, and thereby more accurately detect new markings or changes based on these calculations. Once the original photographs are taken, one of each individual's original skin marking will be enhanced/enlarged with a marking pen, as well as 3-5 new marks added to the skin. A Sharpie brush tip permanent marker will be utilized to make the new skin markings. A second photograph will be taken of the same areas of the body chosen for the initial photographs in order to determine if the application could detect the changes.
Measured: Baseline
Secondary outcomes (1)
Sensitivity of an automated total body digital photography (TBDP) in high risk subjects
Data will be compared between the last picture taken by the app before the clinic visit and the lesions seen by the clinician at the clinic visit. Total number of lesions will be those detected by the clinician, which were not present in the baseline skin evaluation.
Measured: Baseline, 6 and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startMar 2016
- Primary completion7 Nov 2018
- Study completion2 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Skin LesionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatrice Nardone, Northwestern University
- Investigators
- Beatrice Nardone, MD, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740257
- Sponsor's protocol ID
- STU00202166
- Status last verified
- Jan 2023
- First submitted
- 31 Mar 2016
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Brewer AC, Endly DC, Henley J, Amir M, Sampson BP, Moreau JF, Dellavalle RP. Mobile applications in dermatology. JAMA Dermatol. 2013 Nov;149(11):1300-4. doi: 10.1001/jamadermatol.2013.5517.
PubMed 24067948Kohler BA, Sherman RL, Howlader N, Jemal A, Ryerson AB, Henry KA, Boscoe FP, Cronin KA, Lake A, Noone AM, Henley SJ, Eheman CR, Anderson RN, Penberthy L. Annual Report to the Nation on the Status of Cancer, 1975-2011, Featuring Incidence of Breast Cancer Subtypes by Race/Ethnicity, Poverty, and State. J Natl Cancer Inst. 2015 Mar 30;107(6):djv048. doi: 10.1093/jnci/djv048. Print 2015 Jun.
PubMed 25825511Suneja T, Smith ED, Chen GJ, Zipperstein KJ, Fleischer AB Jr, Feldman SR. Waiting times to see a dermatologist are perceived as too long by dermatologists: implications for the dermatology workforce. Arch Dermatol. 2001 Oct;137(10):1303-7. doi: 10.1001/archderm.137.10.1303.
PubMed 11594853Tsang MW, Resneck JS Jr. Even patients with changing moles face long dermatology appointment wait-times: a study of simulated patient calls to dermatologists. J Am Acad Dermatol. 2006 Jul;55(1):54-8. doi: 10.1016/j.jaad.2006.04.001. Epub 2006 May 6.
PubMed 16781292Jacobson CC, Resneck JS Jr, Kimball AB. Generational differences in practice patterns of dermatologists in the United States: implications for workforce planning. Arch Dermatol. 2004 Dec;140(12):1477-82. doi: 10.1001/archderm.140.12.1477.
PubMed 15611425Robson Y, Blackford S, Roberts D. Caution in melanoma risk analysis with smartphone application technology. Br J Dermatol. 2012 Sep;167(3):703-4. doi: 10.1111/j.1365-2133.2012.11046.x. Epub 2012 Jul 5. No abstract available.
PubMed 22762381Ferrero NA, Morrell DS, Burkhart CN. Skin scan: a demonstration of the need for FDA regulation of medical apps on iPhone. J Am Acad Dermatol. 2013 Mar;68(3):515-6. doi: 10.1016/j.jaad.2012.10.045. No abstract available.
PubMed 23394920Wolf JA, Moreau JF, Akilov O, Patton T, English JC 3rd, Ho J, Ferris LK. Diagnostic inaccuracy of smartphone applications for melanoma detection. JAMA Dermatol. 2013 Apr;149(4):422-6. doi: 10.1001/jamadermatol.2013.2382.
PubMed 23325302
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Lesion Detection With Novel Total Body Digital Photography Smartphone Application
- ClinicalTrials.gov ID
- NCT02740257
- Acronym / sponsor ID
- STU00202166
- Conditions
- Skin Lesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 7 Nov 2018 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 15 Apr 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 primary objective of Part One of this study is to determine the sensitivity of an automated total body digital photography (TBDP) app to detect color and size changes in the human skin, and whether a new lesion has arisen.
The primary objective of Part Two is to test the sensitivity and specificity as well as feasibility of field use of an automated TBDP app to detect pigmented and non-pigmented skin lesions in high risk populations.
Detailed description
SkinIO is an early-stage healthcare IT company specializing in education, early detection, and prevention of skin cancer. This study will utilize their product, skinIO, an enhanced full-body skin cancer screening system that works on mobile devices and tablets to track changes in skin over time without any additional imaging hardware. skinIO enables dermatology staff to photograph high-risk patients in 13 medical photography poses to quickly capture full-body skin surfaces at multiple resolutions using a mobile device. These images are automatically uploaded to a HIPAA-compliant server environment where they will be rapidly processed to detect any spots, lesions, and moles. Dermatologists will then be able to annotate these images and flag specific images for follow-up every month.
In order to assess whether or not the software will accurately detect spot changes, the investigators will test the product on a sample of volunteer subjects.
Part One:
The study population will undergo one study visit. This visit will include 2 sets of photos taken by the research team after the collection of a small amount of identifying and contact information for each subject. There will be an initial 3-5 photographs taken of areas of the body that have at least 3 natural or artificial skin markings (ie. moles, angiomas, scars, keloids, seborrheic keratosis, small tattoos, etc). These markings will allow the app to calculate the parameters of any original lesions, and thereby more accurately detect new markings or changes based on these calculations. Once the original photographs are taken, one of each individual's original skin marking will be enhanced/enlarged with a marking pen, as well as 3- 5 new marks added to the skin. A Sharpie brush tip permanent marker will be utilized to make the new skin markings. These markers have been AP certified to be non-toxic. The following colors have been chosen: orange, black, brown, red, blue, purple, yellow and pink. A second photograph will be taken of the same areas of the body chosen for initial photographs to determine if the application could detect the changes. This group will not have their images sent to a dermatologist for evaluation, as they are artificially produced.
Part Two:
In order to test the sensitivity and feasibility of field of use of the TBDP app, a second convenience sample of patients will be recruited. Recruitment will be done in waiting rooms with the attending physician's consent. If needed, recruitment will be done outside of the waiting room in the form of flyers, website and e-mail announcements. This population will consist of patients with known high risk to have new/changing lesions, and who fall within the Fitzpatrick skin types I-IV. High risk patients include, but are not limited to, those with dysplastic nevus syndrome, previous history of melanoma/non-melanoma skin cancer, fair skin, >16 nevi, family history of melanoma, and/or immunosuppressed status. The first photography session will be taken by the research team in all 13 projections. Each projection corresponds to each body area that will be photographed to ensure total body photography. After the first visit, the patient will be instructed to take photographs every month for 12 months using the TBDP app on their smart phone or tablet, and have follow-up research appointments every 6 months. The patient will be provided a user guide with written instructions for application use. The TBDP app has a built-in reminder system for the patient. Any changes detected by the app will be stored on the research team's database. Standard of care will be followed for any new/changing lesions. Patients will be recommended to have a follow-up appointment with their dermatologist, within 2 weeks. No procedures will be completed by the research team, and a physician will not be seeing the patients during their research appointments. During these visits, the research team will compare the photographs taken by the TBDP app to the patient's skin to see how sensitive the app is. Patients will continue their regular office visits at 6 months and/or 12 months as per standard of care for high risk patients. The research team will use information from chart reviews for assessment of the outcome for new or changing lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Artificial Lesions | – | Other: PhotosPhotos will be taken of skin lesion markings using a smartphone |
| Group 2 high risk | – | Other: PhotosA convenience sample of patients will be recruited. This population will consist of patients with known high risk to have new/changing lesions, and who fall within the Fitzpatrick skin types I-IV. High risk patients include, but are not limited to, those with dysplastic nevus syndrome, previous history of melanoma/non-melanoma skin cancer, fair skin, >16 nevi, family history of melanoma, and/or immunosuppressed status. The first photography session will be taken by the research team in all 13 projections. After the first visit, the patient will be instructed to take photographs every month for 12 months using the TBDP app on their smart phone or tablet, and have follow-up research appointments every 6 months. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with various skin types (Fitzpatrick I-IV)
Key inclusion criteria (11 listed)
- Males and females age 18 - 85.
- Subjects with the following skin types:
- Subjects who deny prior skin reactions to washable markers.
- Subjects who have natural skin markings on at least 3 areas of their body.
- Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator in English.
Key exclusion criteria (12 listed)
- Subjects who have a history of skin disease (eg. vitiligo, psoriasis)
- Subjects with the following skin types:
- H] Subjects must be high risk. High risk is defined as subjects with conditions including, but not limited to: dysplastic nevus syndrome, previous history of melanoma/non-melanoma skin cancer, fair skin, >16 nevi, family history of melanoma, immunosuppressed status I] Subjects must have an iPhone 4S or newer, or an iPad Air 2, iPad Mini 4 or iPad Pro in order to download and use the application and take photographs of high enough quality for the physician to analyze if needed.
- J] Subjects must have someone who is able to take photos of the subject every month. The designated individual may or may not be present at the initial encounter.
- 4.2 Exclusion Criteria A] Subjects who have a history of skin disease (eg. vitiligo, psoriasis)
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 |
|---|---|---|
| PhotosPhotos will be taken of skin lesion markings using a smart phone or tablet | Other | Group 1 Artificial Lesions, Group 2 high risk |
Primary outcome
Sensitivity of an automated total body digital photography (TBDP)
Time frame: Baseline
We will assess whether or not the photography software can accurately detect spot changes. We will test the product on a sample of volunteer subjects. The study population will undergo one study visit and will include 2 sets of photos. There will be an initial 3-5 photographs taken of areas of the body that have at least 3 natural or artificial skin markings. These markings will allow the app to calculate the parameters of any original lesions, and thereby more accurately detect new markings or changes based on these calculations. Once the original photographs are taken, one of each individual's original skin marking will be enhanced/enlarged with a marking pen, as well as 3-5 new marks added to the skin. A Sharpie brush tip permanent marker will be utilized to make the new skin markings. A second photograph will be taken of the same areas of the body chosen for the initial photographs in order to determine if the application could detect the changes.
1 secondary outcome
Sensitivity of an automated total body digital photography (TBDP) in high risk subjects
Time frame: Baseline, 6 and 12 months follow-up
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 4 Jan 2023.
- Results publication: PubMed 24067948Brewer AC, Endly DC, Henley J, Amir M, Sampson BP, Moreau JF, Dellavalle RP. Mobile applications in dermatology. JAMA Dermatol. 2013 Nov;149(11):1300-4. doi: 10.1001/jamadermatol.2013.5517.
- Results publication: PubMed 25825511Kohler BA, Sherman RL, Howlader N, Jemal A, Ryerson AB, Henry KA, Boscoe FP, Cronin KA, Lake A, Noone AM, Henley SJ, Eheman CR, Anderson RN, Penberthy L. Annual Report to the Nation on the Status of Cancer, 1975-2011, Featuring Incidence of Breast Cancer Subtypes by Race/Ethnicity, Poverty, and State. J Natl Cancer Inst. 2015 Mar 30;107(6):djv048. doi: 10.1093/jnci/djv048. Print 2015 Jun.
- Results publication: PubMed 11594853Suneja T, Smith ED, Chen GJ, Zipperstein KJ, Fleischer AB Jr, Feldman SR. Waiting times to see a dermatologist are perceived as too long by dermatologists: implications for the dermatology workforce. Arch Dermatol. 2001 Oct;137(10):1303-7. doi: 10.1001/archderm.137.10.1303.
- Results publication: PubMed 16781292Tsang MW, Resneck JS Jr. Even patients with changing moles face long dermatology appointment wait-times: a study of simulated patient calls to dermatologists. J Am Acad Dermatol. 2006 Jul;55(1):54-8. doi: 10.1016/j.jaad.2006.04.001. Epub 2006 May 6.
- Results publication: PubMed 15611425Jacobson CC, Resneck JS Jr, Kimball AB. Generational differences in practice patterns of dermatologists in the United States: implications for workforce planning. Arch Dermatol. 2004 Dec;140(12):1477-82. doi: 10.1001/archderm.140.12.1477.
- Results publication: PubMed 22762381Robson Y, Blackford S, Roberts D. Caution in melanoma risk analysis with smartphone application technology. Br J Dermatol. 2012 Sep;167(3):703-4. doi: 10.1111/j.1365-2133.2012.11046.x. Epub 2012 Jul 5. No abstract available.
- Results publication: PubMed 23394920Ferrero NA, Morrell DS, Burkhart CN. Skin scan: a demonstration of the need for FDA regulation of medical apps on iPhone. J Am Acad Dermatol. 2013 Mar;68(3):515-6. doi: 10.1016/j.jaad.2012.10.045. No abstract available.
- Results publication: PubMed 23325302Wolf JA, Moreau JF, Akilov O, Patton T, English JC 3rd, Ho J, Ferris LK. Diagnostic inaccuracy of smartphone applications for melanoma detection. JAMA Dermatol. 2013 Apr;149(4):422-6. doi: 10.1001/jamadermatol.2013.2382.
- Individual participant dataSharing planned: No
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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.
Beatrice Nardone, MD, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Lesion, run by Northwestern University at 1 site in United States.
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 11 inclusion and 12 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 4 Jan 2023. 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 United States. 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?
Sensitivity of an automated total body digital photography (TBDP) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02740257, which also lists 8 linked publications.
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 4 Jan 2023.