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Interactions Between Skincare Product Ingredients and the Skin Microbiome

Primary Purpose

Dysbiosis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Paraben-free skincare product

Paraben-containing skincare product

About this trial

This is an interventional basic science trial for Dysbiosis focused on measuring microbiome, skincare, skin, paraben, phthalate

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Individuals aged 15 and over
No known medical conditions that, in the investigator's opinion, may interfere with study participation.

Exclusion Criteria:

Individuals who have been on any medication (including antibiotics, probiotics, prebiotics) that has caused a change in current skin composition of interest based on the opinion of the investigator.
Individuals with systemic antibiotic use within last 60 days.
Individuals with topical antibiotic use on the test sites within last 30 days
Individuals unwilling/unable to avoid topical antibiotics, systemic antibiotics, prebiotics, and probiotics during study.
No other interfering skin products should be used during duration of study. (Paraben-free & phthalate-free personal product "safe" list will be provided for other uses during study period if needed).
Individuals unwilling or unable to undergo 1 week wash-in with paraben/phthalate-free products if needed in the opinion of the investigator.
Female volunteers who are pregnant or are actively breastfeeding or planning a pregnancy within two months. (There is no known concern for risk to fetus but pregnancy can alter the microbiome being studied)
Female volunteers who have started a new hormonal birth control agent or switched to a hormonal birth control agent within the past 60 days
Individuals using any interfering skin products in the opinion of the investigator within 2 weeks of enrollment into the study.
Individuals who have participated in any other clinical studies using the same test sites (face) in the past 14 days
Individuals with a known history of hypersensitivity to any ingredients to the cosmetic agent that is being assessed
Individuals who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study at the discretion of the investigator.

Sites / Locations

UC Davis Dermatology Department

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paraben-free then Paraben-containing

Arm Description

Paraben free facial lotion is applied twice a day for 1 week and measurements are taken. Then, paraben-containing facial lotion is applied twice a day for 1 week and measurements are taken.

Outcomes

Primary Outcome Measures

Change in detected paraben levels

Demonstrate the ability to detect chemicals (specifically parabens) found in common ingredients in personal care products on human skin. Collection of isopropyl alcohol forehead wipe and subsequent detection and quantification of parabens by GC-QTOF-MS (gas chromatography) and LC-QTOF-MS (liquid chromatography). Comparisons between baseline, week 1, and week 2 will be made.

Secondary Outcome Measures

Influence of skincare product ingredient (specifically parabens) on facial skin microbiome

Document changes in microbial community composition following application of skin care ingredients of controversial concern (parabens) in comparison with changes following application of products not containing these ingredients. This is assessed by facial swab collections, DNA extraction, and determination of a list of specific bacterial species present at each time point. Comparisons between baseline, week 1, and week 2 will be made.

Full Information

NCT ID

NCT04476732

First Posted

May 15, 2020

Last Updated

July 30, 2020

Sponsor

University of California, Davis

1. Study Identification

Unique Protocol Identification Number

NCT04476732

Brief Title

Interactions Between Skincare Product Ingredients and the Skin Microbiome

Official Title

Interactions Between Skincare Product Ingredients and the Skin Microbiome

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

February 11, 2020 (Actual)

Primary Completion Date

July 16, 2020 (Actual)

Study Completion Date

July 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a study of the influence of skincare products containing chemicals such as parabens and phthalates on the skin microbiome.

Detailed Description

Skin serves as a critical barrier between our bodies and the environment and the locus for a diverse and active microbial community. The composition and metabolic activity of the microbial community on the skin is presumably influenced by the local chemical environment, which includes natural skin lipids (e.g., squalene and sapienic acid), components of personal care products applied directly to skin, and semi-volatile organic compounds (SVOCs) that reach the skin through gas phase absorption, dust deposition, and direct contact with surfaces. Common semi-volatile ingredients in skin care products include phthalates, parabens, and UV blocking compounds (e.g., oxybenzone, octocrylene or homosalate). The investigators have recently demonstrated a method of collecting chemicals from areas of skin with infrequent direct dermal contact using alcohol wipes to assess passive air to skin partitioning of both target and nontarget compounds (Garrido et al., in review). Low-volatility reaction products can accumulate in skin oils and act as skin irritants, with the potential of being absorbed into the bloodstream. With methods developed for chemical and microbiome sampling, the overall goal of the proposed research is to develop an understanding of the two-way interaction between organic chemicals on the skin and the composition of the skin microbiome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dysbiosis

Keywords

microbiome, skincare, skin, paraben, phthalate

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Paraben-free then Paraben-containing

Arm Type

Experimental

Arm Description

Paraben free facial lotion is applied twice a day for 1 week and measurements are taken. Then, paraben-containing facial lotion is applied twice a day for 1 week and measurements are taken.

Intervention Type

Other

Intervention Name(s)

Paraben-free skincare product

Intervention Description

Paraben-free lotion will be applied twice a day for one week.

Intervention Type

Other

Intervention Name(s)

Paraben-containing skincare product

Intervention Description

Paraben-containing lotion will be applied twice a day for one week.

Primary Outcome Measure Information:

Title

Change in detected paraben levels

Description

Time Frame

Baseline, 1 week, 2 weeks

Secondary Outcome Measure Information:

Title

Influence of skincare product ingredient (specifically parabens) on facial skin microbiome

Description

Time Frame

Baseline, 1 week, 2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Individuals aged 15 and over No known medical conditions that, in the investigator's opinion, may interfere with study participation. Exclusion Criteria: Individuals who have been on any medication (including antibiotics, probiotics, prebiotics) that has caused a change in current skin composition of interest based on the opinion of the investigator. Individuals with systemic antibiotic use within last 60 days. Individuals with topical antibiotic use on the test sites within last 30 days Individuals unwilling/unable to avoid topical antibiotics, systemic antibiotics, prebiotics, and probiotics during study. No other interfering skin products should be used during duration of study. (Paraben-free & phthalate-free personal product "safe" list will be provided for other uses during study period if needed). Individuals unwilling or unable to undergo 1 week wash-in with paraben/phthalate-free products if needed in the opinion of the investigator. Female volunteers who are pregnant or are actively breastfeeding or planning a pregnancy within two months. (There is no known concern for risk to fetus but pregnancy can alter the microbiome being studied) Female volunteers who have started a new hormonal birth control agent or switched to a hormonal birth control agent within the past 60 days Individuals using any interfering skin products in the opinion of the investigator within 2 weeks of enrollment into the study. Individuals who have participated in any other clinical studies using the same test sites (face) in the past 14 days Individuals with a known history of hypersensitivity to any ingredients to the cosmetic agent that is being assessed Individuals who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study at the discretion of the investigator.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raja K Sivamani, MD

Organizational Affiliation

UC Davis Dermatology Clinical Trials Unit

Official's Role

Principal Investigator

Facility Information:

Facility Name

UC Davis Dermatology Department

City

Sacramento

State/Province

California

ZIP/Postal Code

95820

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Interactions Between Skincare Product Ingredients and the Skin Microbiome

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