Interactions Between Skincare Product Ingredients and the Skin Microbiome

NCT04476732 | Completed

• 1 other identifier: 1529276
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dysbiosis

Keywords

microbiome; skincare; skin; paraben; phthalate

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 1 week, 2 weeks

Secondary Outcomes (1)

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

  Baseline, 1 week, 2 weeks

Study Arms (1)

Paraben-free then Paraben-containing

EXPERIMENTAL

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.

Other: Paraben-free skincare product; Other: Paraben-containing skincare product

Interventions

Paraben-free skincare product OTHER

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

Paraben-free then Paraben-containing

Paraben-containing skincare product OTHER

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

Paraben-free then Paraben-containing

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Dermatology Department

Sacramento, California, 95820, United States

Location

MeSH Terms

Conditions

Dysbiosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Raja K Sivamani, MD

  UC Davis Dermatology Clinical Trials Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: July 20, 2020
• Study Start: February 11, 2020
• Primary Completion: July 16, 2020
• Study Completion: July 16, 2020
• Last Updated: August 3, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)