The Influence of Personal Care Products on the Skin Microbiome

Microbiome Clinical Trial

Official title:

The Influence of Personal Care Products on the Skin Microbiome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03819179
• Other study ID #: 1161875
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: February 6, 2018

Study information

• Verified date: January 2019
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 6, 2018
• Est. primary completion date: February 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Microbiome

Intervention

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.
• 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).
• 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).
• 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).
• 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.

Locations

Country	Name	City	State
United States	UC Davis Department of Dermatology, Clinical Trials Unit	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 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
Primary	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	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