GeneticsNCT03446079
Relationship of Skin Related SNP to Topical Skin Care Product
A study testing Topical Anti Aging Cream in people with Genetics and Skin Aging, run by HelicalCodeMD at 1 site in United States.
Trial summary
Demonstrate the relationship between single nucleotide polymorphisms (SNP) and response to a topical skin care product. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Genetics, Skin Aging
- What is being tested?
- Topical Anti Aging Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2018to 28 Dec 2022
- Phase
- Interventional
- 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
Who may be able to join
- At least 21 years old in general good health as determined by a health questionnaire.
- Willingness to cooperate and participate by following study requirements and to report any adverse symptoms immediately.
- Willingness to discontinue the use of all facial products other than the assigned test material and their regular brands of glamour products. The glamour products must be the subject's regular brand and have been used for a minimum of one month prior to the start of the study.
- Willingness to remove make up at least 30 minutes prior to each scheduled clinic visit. No other topical products should be applied to the face until the study visit has been completed.
- Willingness to avoid daily direct sun exposure on the face, whether natural or at tanning salons.
- Willingness to discontinue antiaging cosmetics including alpha hydroxyacid products (including Lachydrin©), beta hydroxyacid products (including salicylic acid), poly hydroxyacid products, retinol products, acetyl glucosamine or other effective anti-aging topical products on the face 2 weeks prior to the start of the study and throughout the duration of the study.
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- Completion and signing of a Informed Consent and Enrollment form, HIPAA form, photo release form, medical intake, skin habits survey.
- Willingness to complete all study assessments.
- -
Who cannot join
- Individuals who currently or in the last month have regularly used certain topical or oral medications which, in the opinion of the Investigators, may interfere with the study or that may expose study participants to unacceptable risks. Such products include oral prescription steroids or anti-inflammatories, topical steroids, or prescription skin treatment except for mild acne, as determined by the investigators.
- Subjects who have a history of disease or current disease or regularly use topical or oral medications which, in the opinion of the Investigator, may interfere with the study or that may expose study participants to unacceptable risks. (i.e. oral or topical steroids or anti-inflammatories, etc.).
- Uncontrolled metabolic disease such as diabetes, hyperthyroidism, or hypothyroidism or active Hepatitis, immune deficiency, or autoimmune disease as determined by the health questionnaire.
- Pregnancy, nursing, or planning to become pregnant during the course of the study as determined by the health questionnaire.
- History of skin cancer within the past 6 months.
- Use of topical prescription retinoids for anti-aging including Retin-A®, Retin-A Micro®, Renova®, Avita®, Tazorac®, or Differin® within 2 weeks prior to the start of the study.
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- Use of oral retinoids within 6 months of the study start.
- Subjects must not have had mid-depth or superficial chemical peel or other anti-aging procedures on the face (laser, intense pulsed light, injectable fillers microdermabrasion, etc.) within 2 months of the study start.
- Known allergies or sensitivities to test material ingredients or any topical skin care product (i.e., alpha hydroxyacids, retinol, sunscreens, moisturizers, cleansers, masques, toners, etc.).
- Individuals currently participating in other clinical testing.
- Start of hormone use (including for birth control) or changed hormones less than three months prior to the start of the study. Qualified subjects must not be taking hormones or must have been taking them for at least three months prior to the study start.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship of Skin Related Single Nucleotide Polymorphisms to Clinical Response to a Topical Skin Care Product
Demonstrate the relationship between single nucleotide polymorphisms (SNP) and response to a topical skin care product.
Read the detailed description
Cross sectional study will utilize gene-specific candidate and genome wide association analysis to identify SNP's that may be associated with response to a topical product. Investigators and patients will be blinded to the genetic test results, and participants will be blinded to the skin product applied.
- Conditions
- Genetics, Skin Aging
- Being tested
- Topical Anti Aging Cream
- Keywords
- Genetic, Skin, Anti Aging, SNP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Anti Aging CreamOther
Also called Genetic Test (for association purposes only)
Primary Subjects will take a saliva based genetic test and apply a topical anti aging cream for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Primary Subjects | Experimental | Male or female subjects 21 or older that meet the specified inclusion/exclusion criteria taking genetic test and applying topical anti aging cream per the protocol. Receives: Other: Topical Anti Aging Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic Profile & Product Response
The primary endpoint being studied in this study is the association of the product response to the 17 candidate SNP genotypes.
Measured: 6 weeks
Secondary outcomes (1)
Novel SNP Identification
The secondary endpoint will be identification of novel SNPs through genome-wide association analysis that may be associated with response to the study product.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start19 Mar 2018
- Primary completion31 Jan 2019
- Study completion28 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GeneticsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cross sectional will utilize gene-specific candidate and genome wide association analysis to identify SNP's that may be associated with response to a topical product.
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- HelicalCodeMD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 23andMe, Inc., Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- Katherine Lee, MD, MA, Principal investigator, Member
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446079
- Sponsor's protocol ID
- HCODE1
- Status last verified
- Jun 2023
- First submitted
- 20 Feb 2018
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Skin Related Single Nucleotide Polymorphisms to Clinical Response to a Topical Skin Care Product
- ClinicalTrials.gov ID
- NCT03446079
- Acronym / sponsor ID
- HCODE1
- Conditions
- Genetics, Skin Aging
- Keywords
- Genetic, Skin, Anti Aging, SNP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- HelicalCodeMDIndustry (pharma, biotech, devices)
- Collaborators
- 23andMe, Inc., Johnson & Johnson
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 26 Feb 2018 (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.
Demonstrate the relationship between single nucleotide polymorphisms (SNP) and response to a topical skin care product.
Detailed description
Cross sectional study will utilize gene-specific candidate and genome wide association analysis to identify SNP's that may be associated with response to a topical product. Investigators and patients will be blinded to the genetic test results, and participants will be blinded to the skin product applied.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cross sectional will utilize gene-specific candidate and genome wide association analysis to identify SNP's that may be associated with response to a topical product.
| Arm | Type | Receives |
|---|---|---|
| Primary Subjects | Experimental | Other: Topical Anti Aging CreamMale or female subjects 21 or older that meet the specified inclusion/exclusion criteria taking genetic test and applying topical anti aging cream per the protocol. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 21 years old in general good health as determined by a health questionnaire.
- Willingness to cooperate and participate by following study requirements and to report any adverse symptoms immediately.
- Willingness to discontinue the use of all facial products other than the assigned test material and their regular brands of glamour products. The glamour products must be the subject's regular brand and have been used for a minimum of one month prior to the start of the study.
- Willingness to remove make up at least 30 minutes prior to each scheduled clinic visit. No other topical products should be applied to the face until the study visit has been completed.
- Willingness to avoid daily direct sun exposure on the face, whether natural or at tanning salons.
Key exclusion criteria (11 listed)
- Individuals who currently or in the last month have regularly used certain topical or oral medications which, in the opinion of the Investigators, may interfere with the study or that may expose study participants to unacceptable risks. Such products include oral prescription steroids or anti-inflammatories, topical steroids, or prescription skin treatment except for mild acne, as determined by the investigators.
- Subjects who have a history of disease or current disease or regularly use topical or oral medications which, in the opinion of the Investigator, may interfere with the study or that may expose study participants to unacceptable risks. (i.e. oral or topical steroids or anti-inflammatories, etc.).
- Uncontrolled metabolic disease such as diabetes, hyperthyroidism, or hypothyroidism or active Hepatitis, immune deficiency, or autoimmune disease as determined by the health questionnaire.
- Pregnancy, nursing, or planning to become pregnant during the course of the study as determined by the health questionnaire.
- History of skin cancer within the past 6 months.
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 |
|---|---|---|
| Topical Anti Aging CreamAlso: Genetic Test (for association purposes only)Primary Subjects will take a saliva based genetic test and apply a topical anti aging cream for 6 weeks. | Other | Primary Subjects |
Primary outcome
Genetic Profile & Product Response
Time frame: 6 weeks
The primary endpoint being studied in this study is the association of the product response to the 17 candidate SNP genotypes.
1 secondary outcome
Novel SNP Identification
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Katherine Lee, MD, MA principal investigator
Member
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Anti Aging Cream in people with Genetics and Skin Aging, run by HelicalCodeMD 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 9 inclusion and 11 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: finished, as of the sponsor's last update on 3 Jul 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic Profile & Product Response (time frame: 6 weeks). 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 3 Jul 2023.