Relationship of Skin Related SNP to Topical Skin Care Product

NCT03446079 | Completed DMC

• 1 other identifier: HCODE1
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

Demonstrate the relationship between single nucleotide polymorphisms (SNP) and response to a topical skin care product.

Conditions

Genetics; Skin Aging

Keywords

Genetic; Skin; Anti Aging; SNP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Novel SNP Identification

  6 weeks

Study Arms (1)

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.

Other: Topical Anti Aging Cream

Interventions

Topical Anti Aging Cream OTHER

Primary Subjects will take a saliva based genetic test and apply a topical anti aging cream for 6 weeks.

Also known as: Genetic Test (for association purposes only)

Primary Subjects

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• HelicalCodeMD: lead
• 23andMe, Inc.: collaborator
• Johnson & Johnson: collaborator

Study Sites (1)

Halcyon Dermatology

Laguna Hills, California, 92653, United States

Location

MeSH Terms

Interventions

Genetic Testing

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Katherine Lee, MD, MA

  Member

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Investigators and participants will be blinded to the results genetic testing results during the trial duration. Only participants will be blinded to the identity of the study product.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: February 26, 2018
• Study Start: March 19, 2018
• Primary Completion: January 31, 2019
• Study Completion: December 28, 2022
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)