Atopic Dermatitis (AD)NCT07813611
Secondary Bacterial Infections and Nasal Colonization in Scabies and Atopic Dermatitis
An observational study of Atopic Dermatitis (AD) and Scabies, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study will evaluate the microbiological profile of secondary bacterial infection and nasal colonization in participants with scabies or atopic dermatitis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis (AD), Scabies, Impetigo
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2026to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants presenting to a dermatology clinic will include patients with dermatologist-confirmed scabies or atopic dermatitis and active impetiginized skin lesions, as well as healthy controls without inflammatory skin disease or signs of infection.
Who may be able to join
- Scabies group: dermatologist-confirmed scabies and an active impetiginized skin lesion.
- Atopic dermatitis group: dermatologist-confirmed atopic dermatitis and an active impetiginized skin lesion.
- Healthy control group: no inflammatory skin disease or clinical signs of infection.
- Written informed consent (and appropriate parent/guardian permission when applicable).
Who cannot join
- Systemic or topical antibiotic use within the previous 14 days.
- Active nasal infection or nasal symptoms.
- History of nasal surgery or anatomic nasal deformity.
- TEST DRAFT NOTE: The source protocol contains wording that may conflict with inclusion of healthy controls; the final eligibility text must be reconciled with the ethics-approved protocol before release.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Microbiological Profile of Secondary Bacterial Infections and Nasal Colonization in Patients With Scabies and Atopic Dermatitis: A Prospective Observational Study
This prospective observational study will evaluate the microbiological profile of secondary bacterial infection and nasal colonization in participants with scabies or atopic dermatitis. Bacteria isolated from impetiginized skin lesions and nasal swabs will be compared, and antimicrobial susceptibility patterns will be assessed. Healthy participants without an inflammatory skin disease or signs of infection will provide nasal swabs as a control group. Patients will be followed on days 7 and 14 to assess clinical response and related clinical measures.
Read the detailed description
Participants with dermatologist-confirmed scabies or atopic dermatitis and active impetiginized skin lesions will undergo clinical assessment and microbiological sampling. A superficial swab will be obtained from the infected skin lesion and a nasal swab will be obtained from the nasal vestibules. Healthy controls will undergo nasal sampling only. Cultures will be evaluated for Staphylococcus aureus, Streptococcus pyogenes, and other bacterial isolates. Antimicrobial susceptibility testing will be performed according to European Committee on Antimicrobial Susceptibility Testing (EUCAST) guidance. Skin and nasal isolates will be compared at the species level and by antimicrobial resistance profile. Clinical data include age, sex, disease duration, comorbidities, recent treatments, itch severity using a 0-10 visual analog scale, and lesion morphology, location, number, and excoriation. Patients will be contacted on days 7 and 14 to assess clinical response, new lesion development, change in itch severity, treatment adherence, and local or systemic adverse events.
- Conditions
- Atopic Dermatitis (AD), Scabies, Impetigo
- Keywords
- Staphylococcus aureus, Streptococcus pyogenes, Nasal colonization, Impetiginization, Antimicrobial resistance, MRSA
- Medical subject headings
- Dermatitis, Atopic, Scabies, Impetigo, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Scabies with impetiginized lesions | Participants with dermatologist-confirmed scabies and an active impetiginized skin lesion suggestive of secondary bacterial infection. | |
| Atopic dermatitis with impetiginized lesions | Participants with dermatologist-confirmed atopic dermatitis and an active impetiginized skin lesion suggestive of secondary bacterial infection. | |
| Healthy controls | Participants without an inflammatory skin disease or clinical signs of infection; nasal swab sampling only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of bacterial species between impetiginized skin lesion and nasal cultures
Among participants in the scabies and atopic dermatitis groups with paired evaluable skin and nasal cultures, concordance will be defined as isolation of the same bacterial species from both anatomical sites. Species-level agreement will be summarized and evaluated using Cohen's kappa coefficient.
Measured: At baseline (enrollment)
Secondary outcomes (5)
Bacterial profile of impetiginized skin lesions
The number and proportion of lesion cultures yielding Staphylococcus aureus, Streptococcus pyogenes, other bacteria, mixed growth, or no bacterial growth will be summarized.
Measured: At baseline (enrollment)
Nasal Staphylococcus aureus carriage across study groups
The number and proportion of participants with nasal Staphylococcus aureus carriage will be summarized for the scabies, atopic dermatitis, and healthy control groups.
Measured: At baseline (enrollment)
Antimicrobial susceptibility and resistance profile of bacterial isolates
Antimicrobial susceptibility results, including methicillin resistance among Staphylococcus aureus isolates and susceptibility to the antibiotics included in the laboratory panel, will be summarized for skin and nasal isolates.
Measured: At baseline (enrollment)
Clinical response at day 14
Clinical response will be categorized as complete remission, partial response, no change, or worsening. Associations with bacterial species, methicillin resistance, antimicrobial resistance, nasal carriage, and skin-nasal concordance will be explored.
Measured: 14 days after enrollment
Development of new skin lesions during follow-up
The occurrence of new lesions during the 14-day follow-up period will be recorded.
Measured: Through 14 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies 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
- Time perspective
- Prospective
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tunç Ozen, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Investigators
- TEST INVESTIGATOR - REPLACE, Principal investigator, TEST AFFILIATION - REPLACE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813611
- Sponsor's protocol ID
- SCAB-AD-NASAL-TEST-001
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiological Profile of Secondary Bacterial Infections and Nasal Colonization in Patients With Scabies and Atopic Dermatitis: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07813611
- Acronym / sponsor ID
- SCAB-AD-NASAL-TEST-001
- Conditions
- Atopic Dermatitis (AD), Scabies, Impetigo
- Keywords
- Staphylococcus aureus, Streptococcus pyogenes, Nasal colonization, Impetiginization, Antimicrobial resistance, MRSA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 10 Sep 2026 (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.
This prospective observational study will evaluate the microbiological profile of secondary bacterial infection and nasal colonization in participants with scabies or atopic dermatitis. Bacteria isolated from impetiginized skin lesions and nasal swabs will be compared, and antimicrobial susceptibility patterns will be assessed. Healthy participants without an inflammatory skin disease or signs of infection will provide nasal swabs as a control group. Patients will be followed on days 7 and 14 to assess clinical response and related clinical measures.
Detailed description
Participants with dermatologist-confirmed scabies or atopic dermatitis and active impetiginized skin lesions will undergo clinical assessment and microbiological sampling. A superficial swab will be obtained from the infected skin lesion and a nasal swab will be obtained from the nasal vestibules. Healthy controls will undergo nasal sampling only. Cultures will be evaluated for Staphylococcus aureus, Streptococcus pyogenes, and other bacterial isolates. Antimicrobial susceptibility testing will be performed according to European Committee on Antimicrobial Susceptibility Testing (EUCAST) guidance. Skin and nasal isolates will be compared at the species level and by antimicrobial resistance profile. Clinical data include age, sex, disease duration, comorbidities, recent treatments, itch severity using a 0-10 visual analog scale, and lesion morphology, location, number, and excoriation. Patients will be contacted on days 7 and 14 to assess clinical response, new lesion development, change in itch severity, treatment adherence, and local or systemic adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Scabies with impetiginized lesions | – | –Participants with dermatologist-confirmed scabies and an active impetiginized skin lesion suggestive of secondary bacterial infection. |
| Atopic dermatitis with impetiginized lesions | – | –Participants with dermatologist-confirmed atopic dermatitis and an active impetiginized skin lesion suggestive of secondary bacterial infection. |
| Healthy controls | – | –Participants without an inflammatory skin disease or clinical signs of infection; nasal swab sampling only. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants presenting to a dermatology clinic will include patients with dermatologist-confirmed scabies or atopic dermatitis and active impetiginized skin lesions, as well as healthy controls without inflammatory skin disease or signs of infection.
Key inclusion criteria (4 listed)
- Scabies group: dermatologist-confirmed scabies and an active impetiginized skin lesion.
- Atopic dermatitis group: dermatologist-confirmed atopic dermatitis and an active impetiginized skin lesion.
- Healthy control group: no inflammatory skin disease or clinical signs of infection.
- Written informed consent (and appropriate parent/guardian permission when applicable).
Key exclusion criteria (4 listed)
- Systemic or topical antibiotic use within the previous 14 days.
- Active nasal infection or nasal symptoms.
- History of nasal surgery or anatomic nasal deformity.
- TEST DRAFT NOTE: The source protocol contains wording that may conflict with inclusion of healthy controls; the final eligibility text must be reconciled with the ethics-approved protocol before release.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concordance of bacterial species between impetiginized skin lesion and nasal cultures
Time frame: At baseline (enrollment)
Among participants in the scabies and atopic dermatitis groups with paired evaluable skin and nasal cultures, concordance will be defined as isolation of the same bacterial species from both anatomical sites. Species-level agreement will be summarized and evaluated using Cohen's kappa coefficient.
5 secondary outcomes
Bacterial profile of impetiginized skin lesions
Time frame: At baseline (enrollment)
Nasal Staphylococcus aureus carriage across study groups
Time frame: At baseline (enrollment)
Antimicrobial susceptibility and resistance profile of bacterial isolates
Time frame: At baseline (enrollment)
Clinical response at day 14
Time frame: 14 days after enrollment
Development of new skin lesions during follow-up
Time frame: Through 14 days after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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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.
TEST INVESTIGATOR - REPLACE principal investigator
TEST AFFILIATION - REPLACE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis (AD) and Scabies, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 15 Sep 2026. 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 Turkey (Türkiye). 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TEST CONTACT - REPLACE (+90 000 000 0000, test-contact@example.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance of bacterial species between impetiginized skin lesion and nasal cultures (time frame: At baseline (enrollment)). 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 15 Sep 2026.