Recruiting

Observational Study

Sponsor:

DermTech

Code:

NCT05079737

Conditions

Photoaging

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Mutation Burden

Study Details

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

Study ID

NCT05079737

Start date

Feb 12, 2021

Status verified date

Sep, 2021

Completion date

Sep 15, 2022

Anticipated

Primary completion date

Jun 15, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Mutation Burden

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

Primary outcome measure

  • Prevalence rate of mutations [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Locations

West Dermatology

Recruiting

San Diego, California, United States, 92121

Contacts

More Information

Sponsor

DermTech

Last update posted

Oct 15, 2021

Last verified

Sep, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by DermTech on 2021-10-15.