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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02763163
Other study ID # 1059/15
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 2, 2016
Last updated May 5, 2016
Start date May 2016
Est. completion date September 2016

Study information

Verified date May 2016
Source Institute for Skin Research, Israel
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date September 2016
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria:

- Healthy volunteers between the age of 20-60.

Exclusion Criteria:

- 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.

Study Design

Observational Model: Cohort


Related Conditions & MeSH terms


Intervention

Behavioral:
Sun exposure routine


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Institute for Skin Research, Israel Fischer Pharmaceuticals Ltd.

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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