Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT02740257
Eligibility Criteria:
Inclusion Criteria:
* Males and females age 18 - 85.
* Subjects with the following skin types:
1. Always burns, never tans or
2. Burns easily, then develops light tan or
3. Burns moderately, then develops light tan or
4. 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.
Exclusion Criteria:
* Subjects who have a history of skin disease (eg. vitiligo, psoriasis)
* Subjects with the following skin types:
1. Never burns, always develops a dark tan or
2. 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.
4.2 Exclusion Criteria A\] Subjects who have a history of skin disease (eg. vitiligo, psoriasis)
B\] Subjects with the following skin types:
1. Never burns, always develops a dark tan or
2. 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02740257
Study Brief:
Protocol Section:
NCT02740257