Clinical trial NCT03819179: The Influence of Personal Care Products on the Skin Microbiome
Official title: The Influence of Personal Care Products on the Skin Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microbiome
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: Change in skin microflora
timeFrame: Baseline, 7 days
measure: Change in skin microbiome diversity
timeFrame: Baseline, 7 days
Secondary outcomes:
measure: Self-graded skin type
timeFrame: Baseline
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Department of Dermatology, Clinical Trials Unit
state: California
Study officials:
References: