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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

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

Conditions
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Photoaging

Intervention / Treatment
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* Other: Mutation Burden


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females at least 21 years of age presenting to the clinic for medical consultation; In good health, determined by no clinically significant findings from medical history, Willing to complete all study procedures required by the protocol; and Willing to provide informed consent to participate in this trial. Exclusion Criteria: Have any skin disorder including acne, rosacea, psoriasis, atopic dermatitis and active skin cancer(s) that appear in the facial area where sample collection will be taken and could confound the results of the trial; Has a suspicious lesion (i.e., actinic keratosis lesion) in an area that is expected to be sampled and requires further medical follow-up, Pregnant or breast feeding, Hospitalization within 4 weeks before enrollment, Previously provided samples for this study, Receipt of any investigational drug therapy within four weeks of study enrollment, or concurrent participation in another interventional clinical study, Documented substance abuse, any other significant medical condition that would indicate an unreasonable risk to the potential study participate or potential interference with the procedures, or would negatively affect the study subject's reliability and compliance with the study schedule of events, and Chemical peel or treatment with a laser in the facial area within 3 months prior to enrollment.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with Fitzpatrick Skin Type I-III<br>Subjects 21 years of age or older with Fitzpatrick Skin Type I-III will be enrolled and analyzed by age. | Other: Mutation Burden<br>* Subjects will have their facial samples analyzed for DNA mutation burden.<br>|
| Subjects with Fitzpatrick Skin Type IV-VII<br>Subjects 21 years of age or older with Fitzpatrick Skin Type IV-VII will be enrolled and analyzed by age. | Other: Mutation Burden<br>* Subjects will have their facial samples analyzed for DNA mutation burden.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence rate of mutations | The prevalence rate of selected DNA mutations will be quantitated | 1 day | 

Secondary Outcome Measures

| Outcome Measure | 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 | 1 day |