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This is a multi-center, sample collection study to quantitatively assess the presence of gene mutations in subject's skin collected non-invasively. Subjects who consult with a dermatologist or other clinicians will be approached for participation in the study. Once IRB approved informed consent is obtain, subject demographic information, history of sun exposure and samples will be collected.
This is a multi-center, sample collection study to quantitatively assess the presence of gene mutations in subject's skin collected non-invasively. Subjects who consult with a dermatologist or other clinicians will be approached for participation in the study. Once confirmation of participation is confirmed subjects will undergo the informed consent process.
Once consented the subject will have their medical history reviewed, concomitant medications and demographic information recorded, complete a sun-exposure questionnaire, have photoaging characteristics (such as melasma, wrinkles, AK lesion(s)) recorded, record their assessment of photoaging, have skin samples collected non-invasively and complete the local skin reaction and local tolerability assessments. A select number of subjects will also have a facial photograph taken.
If the location to be sampled contains a lesion, then the collection should occur as close as possible to the target area. The site staff and/or subject will be responsible for collecting the skin samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with Fitzpatrick Skin Type I-III | Subjects 21 years of age or older with Fitzpatrick Skin Type I-III will be enrolled and analyzed by age. |
| |
| Subjects with Fitzpatrick Skin Type IV-VII | Subjects 21 years of age or older with Fitzpatrick Skin Type IV-VII will be enrolled and analyzed by age. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mutation Burden | Other | Subjects will have their facial samples analyzed for DNA mutation burden. |
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence rate of mutations | The prevalence rate of selected DNA mutations will be quantitated | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Correlate gene mutations with demographic information | prevalence of mutations relative to age, sex, race and ethnicity | 1 day |
| Correlation gene mutation with sun exposure scores | prevalence of mutations relative to life time sun exposure |
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Inclusion Criteria:
Exclusion Criteria:
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Up to approximately 5,000 adults presenting to clinics for consultations will be enrolled into this study.
Subjects will be enrolled across a wide range of demographics and age ranges. A minimum of 3000 subjects of Fitzpatrick Skin Type I-III skin types (Group 1) and 1000 subjects of Fitzpatrick IV-VI (Group 2) will be enrolled. This will include, but is not limited to races such as Caucasian, African American, and subjects of Asian descent. At least 100 subjects per Fitzpatrick Skin Type group will be from the following age ranges; 21-30, 31-40, 41-50, 51-60 and >61 will be enrolled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James Rock | Contact | 18582052736 | jrock@dermtech.com |
| Name | Affiliation | Role |
|---|---|---|
| Loren Clarke, MD | DermTech | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Dermatology | Recruiting | San Diego | California | 92121 | United States |
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Skin samples collected non-invasively from the face using the DermTech non-invasive sample collection kit will be collected and stored for future DNA mutation assessment.
| 1 day |