PhotoagingNCT05079737
Sample Collection Study to Assess Prevalence of Gene Mutations: Establishing Population Norms
An observational study of Photoaging, run by DermTech at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Photoaging
- What is being tested?
- Mutation Burden
- Type of treatment
- Injection or infusion
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2021to 15 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
West Dermatology
San Diego, California, 92121
Leslie Aguilar, 858-657-1004, laguilar@CLDerm.com
Hannon
About this study
Official title: A Sample Collection Study to Assess the Prevalence of Gene Mutations Associated With Photoaging in Facial Skin From Adults: Establishing Population Norms
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.
- Conditions
- Photoaging
- Being tested
- Mutation Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mutation BurdenOther
Subjects will have their facial samples analyzed for DNA mutation burden.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Mutation Burden |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence rate of mutations
The prevalence rate of selected DNA mutations will be quantitated
Measured: 1 day
Secondary outcomes (2)
Correlate gene mutations with demographic information
prevalence of mutations relative to age, sex, race and ethnicity
Measured: 1 day
Correlation gene mutation with sun exposure scores
prevalence of mutations relative to life time sun exposure
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start12 Feb 2021
- Primary completion15 Jun 2022 (estimated)
- Study completion15 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotoagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DermTech
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loren Clarke, MD, Study director, DermTech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079737
- Sponsor's protocol ID
- DermTech 21-02
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sample Collection Study to Assess the Prevalence of Gene Mutations Associated With Photoaging in Facial Skin From Adults: Establishing Population Norms
- ClinicalTrials.gov ID
- NCT05079737
- Acronym / sponsor ID
- DermTech 21-02
- Conditions
- Photoaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- DermTechUniversity, hospital or other
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 15 Jun 2022 (estimated)
- Study completion
- 15 Sep 2022 (estimated)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with Fitzpatrick Skin Type I-III | – | Other: Mutation BurdenSubjects 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 | – | Other: Mutation BurdenSubjects 21 years of age or older with Fitzpatrick Skin Type IV-VII will be enrolled and analyzed by age. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mutation BurdenSubjects will have their facial samples analyzed for DNA mutation burden. | Other | Subjects with Fitzpatrick Skin Type I-III, Subjects with Fitzpatrick Skin Type IV-VII |
Primary outcome
Prevalence rate of mutations
Time frame: 1 day
The prevalence rate of selected DNA mutations will be quantitated
2 secondary outcomes
Correlate gene mutations with demographic information
Time frame: 1 day
Correlation gene mutation with sun exposure scores
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loren Clarke, MD study director
DermTech
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Photoaging, run by DermTech at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Rock (18582052736, jrock@dermtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence rate of mutations (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.