Clinical trial NCT05079737: Sample Collection Study to Assess Prevalence of Gene Mutations: Establishing Population Norms
Official title: A Sample Collection Study to Assess the Prevalence of Gene Mutations Associated With Photoaging in Facial Skin From Adults: Establishing Population Norms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Photoaging
Lead sponsor: DermTech
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 5000
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Males and females at least 21 years of age presenting to the clinic for medical consultation;
2. In good health, determined by no clinically significant findings from medical history,
3. Willing to complete all study procedures required by the protocol; and
4. Willing to provide informed consent to participate in this trial.

Exclusion Criteria:

1. 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;
2. Has a suspicious lesion (i.e., actinic keratosis lesion) in an area that is expected to be sampled and requires further medical follow-up,
3. Pregnant or breast feeding,
4. Hospitalization within 4 weeks before enrollment,
5. Previously provided samples for this study,
6. Receipt of any investigational drug therapy within four weeks of study enrollment, or concurrent participation in another interventional clinical study,
7. 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
8. Chemical peel or treatment with a laser in the facial area within 3 months prior to enrollment.

Primary outcomes:
measure: Prevalence rate of mutations
timeFrame: 1 day
Secondary outcomes:
measure: Correlate gene mutations with demographic information
timeFrame: 1 day
measure: Correlation gene mutation with sun exposure scores
timeFrame: 1 day
Other outcomes:
Locations:
city: San Diego
country: United States
facility: West Dermatology
state: California
Study officials:
affiliation: DermTech
name: Loren Clarke, MD
role: STUDY_DIRECTOR
References: