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Relationship of Skin Related SNP to Topical Skin Care Product

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03446079
Recruitment Status : Enrolling by invitation
First Posted : February 26, 2018
Last Update Posted : February 21, 2019
Sponsor:
Collaborators:
23andMe, Inc.
Johnson & Johnson
Information provided by (Responsible Party):
HelicalCodeMD

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

Condition or disease Intervention/treatment Phase
Genetics Skin Aging Other: Topical Anti Aging Cream Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Relationship of Skin Related Single Nucleotide Polymorphisms to Clinical Response to a Topical Skin Care Product
Actual Study Start Date : March 19, 2018
Estimated Primary Completion Date : April 19, 2020
Estimated Study Completion Date : April 19, 2020

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 Name: Genetic Test (for association purposes only)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446079


Locations
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United States, California
Halcyon Dermatology
Laguna Hills, California, United States, 92653
Sponsors and Collaborators
HelicalCodeMD
23andMe, Inc.
Johnson & Johnson
Investigators
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Principal Investigator: Katherine Lee, MD, MA Member
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Responsible Party: HelicalCodeMD
ClinicalTrials.gov Identifier: NCT03446079    
Other Study ID Numbers: HCODE1
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HelicalCodeMD:
Genetic
Skin
Anti Aging
SNP