Skin Diseases, InfectiousNCT05608382
Effect of an Antiseptic Solution on the Skin Microbiome
A study testing sterile Phosphate Buffer Saline and SGW13 in people with Skin Diseases, Infectious, run by Center for Innovation and Research Organization at 1 site in United States.
Trial summary
The objective of this study is simulate the clinical use of an antiseptic solution in a 24 hour window and the recovery to baseline conditions at 1 month following application. Efficacy will be simulated as the capacity of the material to reduce or clear the skin bacterial population from a representative skin area… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Diseases, Infectious
- What is being tested?
- sterile Phosphate Buffer Saline and SGW13
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2022to 18 Mar 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject may be eligible for study participation if all of the following criteria are met:
- Subject is male or female greater than 18 years of age.
- Subject does not have a history of skin allergies/atopia (e.g. atopic dermatitis).
- Subject does not have a history of skin disease (e.g scleroderma, vitiligo, psoriasis) or a chronic systemic disease affecting the skin (e.g systemic lupus erythematosus).
- Subject is willing to have materials applied and follow the protocol.
- Subject agrees to avoid exposure of the test sites to the sun, chemical product, clothes and to refrain from touching the area of application (for T0 [baseline], T1 [5 minutes], T2 [2 hours]).
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- Subject agrees to refrain from getting a bath/shower before T3 (24 h).
- Subject agrees to avoid scrubbing, applying, and/or washing the test area with new soap, moistures, powders, lotions, cosmetic or toiletry products during the study.
- Subject is able to follow directions as outlined in the protocol and anticipates being available for all study visits.
- Subject is willing to participate in all study evaluations.
- Subject is in generally good health.
- Subject is willing to sign the Informed Consent form prior to study participation
Who cannot join
- Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control.
- Subject is immunologically compromised or has received specific topical treatment (antimicrobial or not-antimicrobial), during the last month.
- Subject reports a history of allergies to antiseptics.
- Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study.
- Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Innovation and Research Organization
Philadelphia, Pennsylvania, 19107
About this study
The objective of this study is simulate the clinical use of an antiseptic solution in a 24 hour window and the recovery to baseline conditions at 1 month following application. Efficacy will be simulated as the capacity of the material to reduce or clear the skin bacterial population from a representative skin area: the anteromedial forearm.
- Conditions
- Skin Diseases, Infectious
- Being tested
- sterile Phosphate Buffer Saline, SGW13
- Medical subject headings
- Skin Diseases, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sterile Phosphate Buffer SalineOther
control group
SGW13Other
active comparator
| Study group | Role | What they receive |
|---|---|---|
| sterile Phosphate Buffer Saline (PBS) | Placebo comparator | Not described Receives: Other: sterile Phosphate Buffer Saline |
| SGW13 | Experimental | Not described Receives: Other: SGW13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colony Forming Unit (CFU) count
Comparison of the number of CFUs counted for each treatment arm
Measured: 5 minutes
Colony Forming Unit (CFU) count
Comparison of the number of CFUs counted for each treatment arm
Measured: 2 hours
Colony Forming Unit (CFU) count
Comparison of the number of CFUs counted for each treatment arm
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start7 Mar 2022
- Primary completion15 Mar 2022
- Study completion18 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Diseases, InfectiousStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Innovation and Research Organization
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Javad Parvizi, MD, Principal investigator, Center for Innovation and Research Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608382
- Sponsor's protocol ID
- SGW2022
- Status last verified
- Oct 2022
- First submitted
- 1 Nov 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Antiseptic Solution on the Skin Microbiome
- ClinicalTrials.gov ID
- NCT05608382
- Acronym / sponsor ID
- SGW2022
- Conditions
- Skin Diseases, Infectious
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Center for Innovation and Research OrganizationResearch network
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 18 Mar 2022 (actual)
- First posted
- 8 Nov 2022 (actual)
- 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.
The objective of this study is simulate the clinical use of an antiseptic solution in a 24 hour window and the recovery to baseline conditions at 1 month following application. Efficacy will be simulated as the capacity of the material to reduce or clear the skin bacterial population from a representative skin area: the anteromedial forearm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sterile Phosphate Buffer Saline (PBS) | Placebo comparator | Other: sterile Phosphate Buffer Saline |
| SGW13 | Experimental | Other: SGW13 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- A subject may be eligible for study participation if all of the following criteria are met:
- Subject is male or female greater than 18 years of age.
- Subject does not have a history of skin allergies/atopia (e.g. atopic dermatitis).
- Subject does not have a history of skin disease (e.g scleroderma, vitiligo, psoriasis) or a chronic systemic disease affecting the skin (e.g systemic lupus erythematosus).
- Subject is willing to have materials applied and follow the protocol.
Key exclusion criteria (5 listed)
- Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control.
- Subject is immunologically compromised or has received specific topical treatment (antimicrobial or not-antimicrobial), during the last month.
- Subject reports a history of allergies to antiseptics.
- Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study.
- Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs.
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 |
|---|---|---|
| sterile Phosphate Buffer Salinecontrol group | Other | sterile Phosphate Buffer Saline (PBS) |
| SGW13active comparator | Other | SGW13 |
Primary outcome
Colony Forming Unit (CFU) count
Time frame: 5 minutes
Comparison of the number of CFUs counted for each treatment arm
Colony Forming Unit (CFU) count
Time frame: 2 hours
Comparison of the number of CFUs counted for each treatment arm
Colony Forming Unit (CFU) count
Time frame: 24 hours
Comparison of the number of CFUs counted for each treatment arm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
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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.
Javad Parvizi, MD principal investigator
Center for Innovation and Research Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sterile Phosphate Buffer Saline and SGW13 in people with Skin Diseases, Infectious, run by Center for Innovation and Research Organization at 1 site in United States.
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 12 inclusion and 5 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: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Colony Forming Unit (CFU) count (time frame: 5 minutes). The study lists 3 primary outcomes in all. 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 8 Nov 2022.