Relationship of Skin Related SNP to Topical Skin Care Product

June 28, 2023 updated by: HelicalCodeMD

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Laguna Hills, California, United States, 92653
        • Halcyon Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. At least 21 years old in general good health as determined by a health questionnaire.
  2. Willingness to cooperate and participate by following study requirements and to report any adverse symptoms immediately.
  3. 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.
  4. 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.
  5. Willingness to avoid daily direct sun exposure on the face, whether natural or at tanning salons.
  6. 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.
  7. Completion and signing of a Informed Consent and Enrollment form, HIPAA form, photo release form, medical intake, skin habits survey.

  8. Willingness to complete all study assessments.

    -

Exclusion Criteria:

  1. 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.
  2. 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.).
  3. Uncontrolled metabolic disease such as diabetes, hyperthyroidism, or hypothyroidism or active Hepatitis, immune deficiency, or autoimmune disease as determined by the health questionnaire.
  4. Pregnancy, nursing, or planning to become pregnant during the course of the study as determined by the health questionnaire.
  5. History of skin cancer within the past 6 months.

  6. 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.

    Use of oral retinoids within 6 months of the study start.

  7. 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.
  8. 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.).
  9. Individuals currently participating in other clinical testing.
  10. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Primary Subjects
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.
Other: Topical Anti Aging Cream
Primary Subjects will take a saliva based genetic test and apply a topical anti aging cream for 6 weeks.
Other Names:
  • Genetic Test (for association purposes only)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Novel SNP Identification
Time Frame: 6 weeks
The secondary endpoint will be identification of novel SNPs through genome-wide association analysis that may be associated with response to the study product.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HelicalCodeMD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johnson & Johnson
23andMe, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katherine Lee, MD, MA, Member

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HCODE1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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