Relationship of Skin Related SNP to Topical Skin Care Product

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: Completed
• Conditions: Genetics; Skin Aging
• Intervention / Treatment: Other: Topical Anti Aging Cream

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: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks

Collaborators and Investigators

• Sponsor: HelicalCodeMD
• Collaborators: Johnson & Johnson; 23andMe, Inc.
• Investigators: Principal Investigator: Katherine Lee, MD, MA, Member

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2018
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): December 28, 2022

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: February 23, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Genetic; Skin; Anti Aging; SNP
• Other Study ID 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