Smartphone Application to Detect Skin Lesions

NCT02740257 | Completed

• 1 other identifier: STU00202166
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Skin Lesion

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (1)

• Sensitivity of an automated total body digital photography (TBDP) in high risk subjects

  Baseline, 6 and 12 months follow-up

Study Arms (2)

Group 1 Artificial Lesions

Photos will be taken of skin lesion markings using a smartphone

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.

Other: Photos

Interventions

Photos OTHER

Photos will be taken of skin lesion markings using a smart phone or tablet

Group 1 Artificial Lesions; Group 2 high risk

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals with various skin types (Fitzpatrick I-IV)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (8)

• 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.

  PMID: 24067948 RESULT

• Kohler 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.

  PMID: 25825511 RESULT

• Suneja 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.

  PMID: 11594853 RESULT

• Tsang 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.

  PMID: 16781292 RESULT

• Jacobson 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.

  PMID: 15611425 RESULT

• Robson 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.

  PMID: 22762381 RESULT

• Ferrero 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.

  PMID: 23394920 RESULT

• Wolf 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.

  PMID: 23325302 RESULT

Study Officials

• Beatrice Nardone, MD, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 15, 2016
• Study Start: March 1, 2016
• Primary Completion: November 7, 2018
• Study Completion: September 2, 2022
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)