The Influence of Personal Care Products on the Skin Microbiome

To evaluate whether personal care products shift the skin microbiome bacteria and diversity after a week of daily use.

Study Overview

• Status: Completed
• Conditions: Microbiome
• Intervention / Treatment: Other: Burt's Bees Serum; Other: Burt's Bees Serum with Biulin; Other: Burt's Bees Serum with Berenew Complex; Other: Burt's Bees Serum with Ecoskin; Other: Burt's Bees Serum with Bonicell

Detailed Description

Studies have shown that microbiome is important in skin conditions such as eczema, rosacea, acne, and many other skin conditions. Personal care products are widely used on a daily basis but it is not know how these personal care products shift the skin's microbiome. The diversity of the skin microbiome is important in the maintenance of skin equilibrium as a loss of diversity predisposes to development of skin disease.

The aim of this study is to evaluate multiple over the counter products that are used on the face daily to assess how they alter skin microbiome and diversity of microflora on skin after a week of daily treatment.

A second aim of the study is to assess how baseline diversity of microbiome are different based on self-graded skin types.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • UC Davis Department of Dermatology, Clinical Trials Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Females, aged 20-45 (limiting to females so that there is not heterogeneity with the influence of hormones. Also, females are a much larger user base of personal care products)
• Individuals in good general health
• Individuals free of any dermatological or systemic disorder, which would interfere with the results, at the discretion of the investigator
• Individuals who have participated in any other clinical studies using the same test sites (face) in the past 14 days

Exclusion Criteria:

• Individuals who have been on any topical antibiotic for the past one month or oral antibiotic therapy for the past 2 months or are currently on any antibiotic therapy
• Individuals who have history of acute or chronic disease that would likely interfere with or increase the risk on study participation at the discretion of the investigator
• Individuals with active (flaring) disease or chronic skin allergies (atopic dermatitis/eczema) or those who have recently undergone treatment for skin cancer (within the last 12 months) in the area of testing on the nose and the cheeks
• Female volunteers who are pregnant or are actively nursing
• 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 who have had any medical or cosmetic procedure, such as laser resurfacing, or plastic surgery to the test site (face) within the last 6 months. This includes botulinum toxin, dermal fillers, collagen or other similar cosmetic procedure
• Individuals who are currently using or during the past 30 days have used a retinoid such as Retin A, or other Rx/over the counter (OTC) Retinyl A or currently using or during the past 14 days have used hydroquinone (skin lightening)
• Individuals with a known history of hypersensitivity to any ingredients to the cosmetic agent that is being assessed
• Individuals with self-reported oily skin that may predispose them to acne form breakouts (at the discretion of the investigator)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Serum; Burt's Bees Serum	Other: Burt's Bees Serum; This is a commercially available over-the-counter product. Ingredients: Caprylic/ Capric Trigylceride, Isopropyl Palmitate, Sweet Almond Oil, Lanette O, Water, Cetearyl Glucoside, Gluconolactone ans Sodium Benzoate, Water, Glycerin, Xanthan GUM, Tocopherol.
Experimental: Serum with Biulin; Burt's Bees Serum with Biulin	Other: Burt's Bees Serum with Biulin; This is a commercially available over-the-counter product. Ingredients: Caprylic/ Capric Trigylceride, Isopropyl Palmitate, Sweet Almond Oil, Lanette O, Water, Cetearyl Glucoside, Gluconolactone ans Sodium Benzoate, Water, Glycerin, Xanthan GUM, Tocopherol, PreBIULIN FOS (GOVA).
Experimental: Serum with Berenew Complex; Burt's Bees Serum with Berenew Complex	Other: Burt's Bees Serum with Berenew Complex; This is a commercially available over-the-counter product. Ingredients: Caprylic/ Capric Trigylceride, Isopropyl Palmitate, Sweet Almond Oil, Lanette O, Water, Cetearyl Glucoside, Gluconolactone ans Sodium Benzoate, Water, Glycerin, Xanthan GUM, Tocopherol, BeRenew CLR Complex (CLR).
Experimental: Serum with Ecoskin; Burt's Bees Serum with Ecoskin	Other: Burt's Bees Serum with Ecoskin; This is a commercially available over-the-counter product. Ingredients: Caprylic/Capric Triglyceride, Dimer Dilinoleyl Dimer Dilionoleatem, Silica, Citronellyl Methylcrotonate, Tocopheryl Acetate, Xymenynic Acid, Alpha-glucan Oligosaccharide, Fragrance, Slareolide, Polymnia sonshifolia root juice, Helianthus annuus (sunflower) seed oil, Maltodextrin, Tocopherol, Beta-sitosterol, Lactobacillus, Squalene.
Experimental: Serum with Bonicell; Burt's Bees Serum with Bonicell	Other: Burt's Bees Serum with Bonicell; This is a commercially available over-the-counter product. Ingredients: Caprylic/ Capric Trigylceride, Isopropyl Palmitate, Sweet Almond Oil, Lanette O, Water, Cetearyl Glucoside, Gluconolactone ans Sodium Benzoate, Water, Glycerin, Xanthan GUM, Tocopherol, Bonicel (Ganaden).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in skin microflora	Cotton swabs will be used to collect sample skin microbiome bacteria from the cheeks and forehead at baseline and 1 week after daily use of the intervention product. These samples will be analysed and the relative components of the microbiome will be a primary outcome.The collected measurement data will be based on a number of operational taxonomic unit (OTU).	Baseline, 7 days
Change in skin microbiome diversity	Cotton swabs will be used to collect sample skin microbiome bacteria from the cheeks and forehead at baseline and 1 week after daily use of the intervention product. These samples will be analysed and change in diversity of the microbiome will constitute a primary outcome. The collected measurement data will be based on a number of operational taxonomic unit (OTU).	Baseline, 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-graded skin type	Types are based on the Fitzpatrick Skin Type Questionnaire, which assesses various items on Genetic Disposition, Reaction to Sun Exposure, and Tanning Habits on a score from 0-4. Skin type I corresponds to a total score of 0-7. Skin type II corresponds to a total score of 8-16. Skin type III corresponds to a total score of 17-25. Skin type IV corresponds to a total score of 25-30. Skin type V-VI correspond to a total score of over 30.	Baseline

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): February 6, 2018
• Study Completion (Actual): February 6, 2018

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (Actual): January 28, 2019

Study Record Updates

• Last Update Posted (Actual): January 28, 2019
• Last Update Submitted That Met QC Criteria: January 25, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1161875

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No