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
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