NCT03819179

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
Last Updated

January 28, 2019

Status Verified

January 1, 2019

Enrollment Period

2 months

First QC Date

January 18, 2019

Last Update Submit

January 25, 2019

Conditions

Microbiome

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Self-graded skin type

    Baseline

Study Arms (5)

Serum

EXPERIMENTAL

Burt's Bees Serum

Other: Burt's Bees Serum

Serum with Biulin

EXPERIMENTAL

Burt's Bees Serum with Biulin

Other: Burt's Bees Serum with Biulin

Serum with Berenew Complex

EXPERIMENTAL

Burt's Bees Serum with Berenew Complex

Other: Burt's Bees Serum with Berenew Complex

Serum with Ecoskin

EXPERIMENTAL

Burt's Bees Serum with Ecoskin

Other: Burt's Bees Serum with Ecoskin

Serum with Bonicell

EXPERIMENTAL

Burt's Bees Serum with Bonicell

Other: Burt's Bees Serum with Bonicell

Interventions

Burt's Bees SerumOTHER

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
Burt's Bees Serum with BiulinOTHER

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 Biulin
Burt's Bees Serum with BonicellOTHER

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).

Serum with Bonicell
Burt's Bees Serum with Berenew ComplexOTHER

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 Berenew Complex
Burt's Bees Serum with EcoskinOTHER

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 Ecoskin

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales, aged 20-45
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Department of Dermatology, Clinical Trials Unit

Sacramento, California, 95816, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2019

First Posted

January 28, 2019

Study Start

December 1, 2017

Primary Completion

February 6, 2018

Study Completion

February 6, 2018

Last Updated

January 28, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)