Interactions Between Skincare Product Ingredients and the Skin Microbiome

Dysbiosis Clinical Trial

Official title:

Interactions Between Skincare Product Ingredients and the Skin Microbiome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04476732
• Other study ID #: 1529276
• Status: Completed
• Phase: N/A
• Start date: February 11, 2020
• Est. completion date: July 16, 2020

Study information

• Verified date: July 2020
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 16, 2020
• Est. primary completion date: July 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dysbiosis

Intervention

Other:
• Paraben-free skincare product
Paraben-free lotion will be applied twice a day for one week.
• Paraben-containing skincare product
Paraben-containing lotion will be applied twice a day for one week.

Locations

Country	Name	City	State
United States	UC Davis Dermatology Department	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, 1 week, 2 weeks