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

NCT05079737 | Unknown

• 1 other identifier: DermTech 21-02
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Photoaging

Outcome Measures

Primary Outcomes (1)

• Prevalence rate of mutations

  The prevalence rate of selected DNA mutations will be quantitated

  1 day

Secondary Outcomes (2)

• Correlate gene mutations with demographic information

  1 day

• Correlation gene mutation with sun exposure scores

  1 day

Study Arms (2)

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.

Other: Mutation Burden

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.

Other: Mutation Burden

Interventions

Mutation Burden OTHER

Subjects will have their facial samples analyzed for DNA mutation burden.

Subjects with Fitzpatrick Skin Type I-III; Subjects with Fitzpatrick Skin Type IV-VII

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DermTech: lead

Study Sites (1)

West Dermatology

San Diego, California, 92121, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

Study Officials

• Loren Clarke, MD

  DermTech

  STUDY DIRECTOR

Central Study Contacts

James Rock

CONTACT

18582052736; jrock@dermtech.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: October 15, 2021
• Study Start: February 12, 2021
• Primary Completion: June 15, 2022
• Study Completion: September 15, 2022
• Last Updated: October 15, 2021

Record last verified: 2021-09

Locations

US (1)