NCT05079737

Sample Collection Study to Assess Prevalence of Gene Mutations: Establishing Population Norms

A Sample Collection Study to Assess the Prevalence of Gene Mutations Associated With Photoaging in Facial Skin From Adults: Establishing Population Norms

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: DermTech · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Photoaging

Interventions

Type	Name	Description
OTHER	Mutation Burden	Subjects will have their facial samples analyzed for DNA mutation burden.

Timeline

• Start date: 2021-02-12
• Primary completion: 2022-06-15
• Completion: 2022-09-15
• First posted: 2021-10-15
• Last updated: 2021-10-15

Locations

1 site across 1 country: United States