HealthyNCT02763163
Examination of the Link Between Sun Exposure Routine and Bacteria Population of the Skin
An observational study of Healthy, run by Institute for Skin Research, Israel.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sun exposure routine
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 100 healthy volunteers
Who may be able to join
- Healthy volunteers between the age of 20-60.
Who cannot join
- 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.
About this study
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.
- Conditions
- Healthy
- Being tested
- Sun exposure routine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sun exposure routineBehavioural
| Study group | Role | What they receive |
|---|---|---|
| outdoor workers | Subjects with an excessive exposure to the sun on a daily basis Receives: Behavioral: Sun exposure routine | |
| office workers | Subjects who spend most of the day in a closed shaded room Receives: Behavioral: Sun exposure routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startMay 2016
- Primary completionAug 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Skin Research, Israel
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fischer Pharmaceuticals Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763163
- Sponsor's protocol ID
- 1059/15
- Status last verified
- May 2016
- First submitted
- 2 May 2016
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Link Between Sun Exposure Routine and Bacteria Population of the Skin
- ClinicalTrials.gov ID
- NCT02763163
- Acronym / sponsor ID
- 1059/15
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute for Skin Research, IsraelIndustry (pharma, biotech, devices)
- Collaborators
- Fischer Pharmaceuticals Ltd.
- Study start
- May 2016
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| outdoor workers | – | Behavioral: Sun exposure routineSubjects with an excessive exposure to the sun on a daily basis |
| office workers | – | Behavioral: Sun exposure routineSubjects who spend most of the day in a closed shaded room |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 100 healthy volunteers
Key inclusion criteria (1 listed)
- Healthy volunteers between the age of 20-60.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sun exposure routine | Behavioural | office workers, outdoor workers |
Primary outcome
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.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Institute for Skin Research, Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2016.