The Influence of Personal Care Products on the Skin Microbiome

NCT ID: NCT03819179

Last Updated: 2019-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2018-02-06

Brief Summary

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

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.

Conditions

Microbiome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Serum

Burt's Bees Serum

Group Type: EXPERIMENTAL

Burt's Bees Serum

Intervention Type: OTHER

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.

Serum with Biulin

Burt's Bees Serum with Biulin

Group Type: EXPERIMENTAL

Burt's Bees Serum with Biulin

Intervention Type: OTHER

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).

Serum with Berenew Complex

Burt's Bees Serum with Berenew Complex

Group Type: EXPERIMENTAL

Burt's Bees Serum with Berenew Complex

Intervention Type: OTHER

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).

Serum with Ecoskin

Burt's Bees Serum with Ecoskin

Group Type: EXPERIMENTAL

Burt's Bees Serum with Ecoskin

Intervention Type: OTHER

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.

Serum with Bonicell

Burt's Bees Serum with Bonicell

Group Type: EXPERIMENTAL

Burt's Bees Serum with Bonicell

Intervention Type: OTHER

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).

Interventions

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.

Intervention Type: 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).

Intervention Type: 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).

Intervention Type: 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).

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UC Davis Department of Dermatology, Clinical Trials Unit

Sacramento, California, United States

Countries

United States

Other Identifiers

1161875

Identifier Type: -

Identifier Source: org_study_id