CClinicalTrials.gg
Status unknownNCT05079737Updated Oct 15, 2021

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

An observational study in Photoaging, sponsored by DermTech. Status unknown at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-15.

Sponsored by DermTech · Observational

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Ecologic or community
Time perspective
Other
Enrollment
5,000
Ages
21 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Photoaging

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03

In context

Skin Diseases

538 studies on the registry are indexed under Skin Diseases; 91 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 168 across 147 observational studies indexed under Skin Diseases.

Browse Skin Diseases studies →

Lead sponsor

DermTech is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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.
05

Study design

Observational model
Ecologic or community
Time perspective
Other
Enrollment
5,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • OtherMutation Burden

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

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What researchers measure

Primary outcomes

  1. Prevalence rate of mutations

    The prevalence rate of selected DNA mutations will be quantitated

    Time frame: 1 day

Secondary outcomes

  1. Correlate gene mutations with demographic information

    prevalence of mutations relative to age, sex, race and ethnicity

    Time frame: 1 day

  2. Correlation gene mutation with sun exposure scores

    prevalence of mutations relative to life time sun exposure

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
  • West Dermatology
    San Diego, California 92121, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05079737
Lead sponsor
DermTech
Responsible party
Sponsor
First posted
Oct 15, 2021
Start date
Feb 12, 2021
Primary completion
Jun 15, 2022 (estimated)
Completion
Sep 15, 2022 (estimated)
Last update
Oct 15, 2021

Study contacts

James Rock
Contact
jrock@dermtech.com
18582052736
Loren Clarke, MD
study director · DermTech

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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