Atopic DermatitisPhase 4NCT06397781
Effect of S. Aureus Skin Decolonization on Disease Severity in Atopic Dermatitis Patients
A Phase 4 study testing Skin Cleanser Combination No.1 in people with Atopic Dermatitis, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Our hypothesis is that S. aureus skin decolonization in atopic dermatitis reduces disease severity and favorably alters the function and gene expression of epidermal and immune skin cells that contribute to disease severity. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Skin Cleanser Combination No.1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2031to Dec 2039
- Phase
- Phase 4
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female participants ≥6 yrs of age
- Meet atopic dermatitis Standard Diagnostic Criteria
- SCORAD > 40.
Who cannot join
- . Enrollment in another clinical trial
- Hypersensitivity to an agent used for the skin decolonization protocol
- Use within 4 weeks of systemic treatment with immunosuppressive/immunomodulating drugs (corticosteroids, cyclosporine, mycophenolate, azathioprine, methotrexate)
- Phototherapy for AD within 4 weeks
- Treatment with biologics (dupilumab, omalizumab, benralizumab, etc) within sixteen weeks
- Use of topical steroids, topical calcineurin inhibitors within 7 days
Show all 15Show fewer
- Bleach baths within 7 days of the first Visit
- Use of oral or topical antibiotics within 21 days of the beginning of the study
- Asthmatics receiving more than 500 μg per day of inhaled corticosteroids
- History of (HIV, hepatitis B, hepatitis C, tuberculosis malignancy
- Skin comorbidities that may interfere with assessments: psoriasis, cutaneous T Cell lymphoma,,
- Severe ongoing medical illnesses e.g. cardiovascular, renal disease, autoimmune disease.
- Febrile illness at time of visits
- Suspected immune deficiency or family history of primary immunodeficiency
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
Principal Investigator, MD, MS
About this study
Our hypothesis is that S. aureus skin decolonization in atopic dermatitis reduces disease severity and favorably alters the function and gene expression of epidermal and immune skin cells that contribute to disease severity.
Read the detailed description
Patients will sign an informed consent and assent to participate. Skin and both nares will be cultured for S aureus. A blood sample and two 2 mm skin biopsies will be obtained one from non-lesional skin and another one from lesional skin). The patients will be instructed in the use of the three-week S. aureus decolonization regimen and provided with the medications (sulfamethoxazole/trimethoprim and Mupirocin ointment) and Chlorhexidine. The second visit will take place immediately at the end of the three-week S. aureus skin decolonization regimen. Disease severity will be assessed, the skin and nares will be re-cultured, and skin biopsies and blood will be obtained.
- Conditions
- Atopic Dermatitis
- Being tested
- Skin Cleanser Combination No.1
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Cleanser Combination No.1Drug
- Mupirocin 2% nasal ointment to the anterior nares to be applied twice daily
- Chlorhexidine 4% topical soap (Hibiclens) to be used every other day in the shower or bath from the neck down and then completely rinsed.
- Sulfamethoxazole/trimethoprim (Bactrim): one double strength (DS) tablet (800 mg/160 mg) twice per day for adolescents and adults. Dosing for pediatric patients will be calculated to 5 to 6 mg/kg trimethoprim also given twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Skin Cleansing Regimen | Experimental | 1. Mupirocin 2% nasal ointment to the anterior nares to be applied twice daily
2. Chlorhexidine 4% topical soap (Hibiclens) to be used every other day in the shower or bath from the neck down and then completely rinsed.
3. Sulfamethoxazole/trimethoprim (Bactrim): one double strength (DS) tablet (800 mg/160 mg) twice per day for adolescents and adults Receives: Drug: Skin Cleanser Combination No.1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity Scoring of Atopic Dermatitis Index
severity index
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 Jan 2031 (estimated)
- Primary completionDec 2035 (estimated)
- Study completionDec 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wanda Phipatanakul, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397781
- Sponsor's protocol ID
- IRB-P00047752
- Status last verified
- Mar 2026
- First submitted
- 30 Apr 2024
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of S. Aureus Skin Decolonization on Disease Severity in Atopic Dermatitis Patients
- ClinicalTrials.gov ID
- NCT06397781
- Acronym / sponsor ID
- IRB-P00047752
- Conditions
- Atopic Dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2031 (estimated)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2039 (estimated)
- First posted
- 3 May 2024 (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.
Our hypothesis is that S. aureus skin decolonization in atopic dermatitis reduces disease severity and favorably alters the function and gene expression of epidermal and immune skin cells that contribute to disease severity.
Detailed description
Patients will sign an informed consent and assent to participate. Skin and both nares will be cultured for S aureus. A blood sample and two 2 mm skin biopsies will be obtained one from non-lesional skin and another one from lesional skin). The patients will be instructed in the use of the three-week S. aureus decolonization regimen and provided with the medications (sulfamethoxazole/trimethoprim and Mupirocin ointment) and Chlorhexidine. The second visit will take place immediately at the end of the three-week S. aureus skin decolonization regimen. Disease severity will be assessed, the skin and nares will be re-cultured, and skin biopsies and blood will be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin Cleansing Regimen | Experimental | Drug: Skin Cleanser Combination No.11. Mupirocin 2% nasal ointment to the anterior nares to be applied twice daily 2. Chlorhexidine 4% topical soap (Hibiclens) to be used every other day in the shower or bath from the neck down and then completely rinsed. 3. Sulfamethoxazole/trimethoprim (Bactrim): one double strength (DS) tablet (800 mg/160 mg) twice per day for adolescents and adults |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female participants ≥6 yrs of age
- Meet atopic dermatitis Standard Diagnostic Criteria
- SCORAD > 40.
Key exclusion criteria (15 listed)
- . Enrollment in another clinical trial
- Hypersensitivity to an agent used for the skin decolonization protocol
- Use within 4 weeks of systemic treatment with immunosuppressive/immunomodulating drugs (corticosteroids, cyclosporine, mycophenolate, azathioprine, methotrexate)
- Phototherapy for AD within 4 weeks
- Treatment with biologics (dupilumab, omalizumab, benralizumab, etc) within sixteen weeks
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 |
|---|---|---|
| Skin Cleanser Combination No.11. Mupirocin 2% nasal ointment to the anterior nares to be applied twice daily 2. Chlorhexidine 4% topical soap (Hibiclens) to be used every other day in the shower or bath from the neck down and then completely rinsed. 3. Sulfamethoxazole/trimethoprim (Bactrim): one double strength (DS) tablet (800 mg/160 mg) twice per day for adolescents and adults. Dosing for pediatric patients will be calculated to 5 to 6 mg/kg trimethoprim also given twice daily. | Drug | Skin Cleansing Regimen |
Primary outcome
Severity Scoring of Atopic Dermatitis Index
Time frame: 3 weeks
severity index
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 10 Mar 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Skin Cleanser Combination No.1 in people with Atopic Dermatitis, run by Boston Children's Hospital 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 3 inclusion and 15 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 10 Mar 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Principal Investigator (617-355-6000, asthma@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity Scoring of Atopic Dermatitis Index (time frame: 3 weeks). 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 10 Mar 2026.