NCT02763163

Brief Summary

These days many studies are conducted testing the symbiosis between the bacteria population to the human body's functioning. The research of the connection between the skin condition and the bacteria population is in its early stages. There is a characterization of different bacteria for different body areas depending on their composition, humidity etc. In addition, there are preliminary findings of biological receptors that react to the contact with bacteria on the surface of the skin and turn on the immune system, awakening it to cope with the new invader. Based on the above information, the investigators hypothesis is that there is a connection between the degrees of sun exposure of individuals to the growing of beneficial bacteria populations on the surface of the skin. The study will compare between the bacteria population on the skin of Israeli subjects, divided to two groups, one with an excessive exposure to the sun on a daily basis, (such as agricultural workers, lifeguards, construction, etc.), and the other of the office worker who spend most of the day in a closed shaded room.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

May 6, 2016

Status Verified

May 1, 2016

Enrollment Period

3 months

First QC Date

May 2, 2016

Last Update Submit

May 5, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Scanning the bacteria population of the surface of the skin by using swab on the cheek area. The samples of bacteria will be characterized by genetic sequencing.

    6 months

Study Arms (2)

outdoor workers

Subjects with an excessive exposure to the sun on a daily basis

Behavioral: Sun exposure routine

office workers

Subjects who spend most of the day in a closed shaded room

Behavioral: Sun exposure routine

Interventions

office workersoutdoor workers

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

100 healthy volunteers

You may qualify if:

  • Healthy volunteers between the age of 20-60.

You may not qualify if:

  • Pregnant or lactating women.
  • Volunteers with a known allergy to one of the tested materials or to their ingredients.
  • Treatment with medication such as anti-inflammatories, antihistamines,corticosteroids, systemically or topically applied, unless stopped for 2 weeks prior to the trial in the case of systemic treatment and 3 days in the case of topical treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2016

First Posted

May 5, 2016

Study Start

May 1, 2016

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

May 6, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share