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New treatment option for Eczema
Official title Effects of Treatments on Atopic Dermatitis
ClinicalTrials.gov ID: NCT01631617
What this study is testing
What is Trimethoprim/sulfamethoxazole (TMP/SMZ)?
Trimethoprim/sulfamethoxazole (TMP/SMZ) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for eczema.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: \- Atopic dermatitis, or eczema, is a chronic skin disorder. Patients sometimes have infections with S.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 50. Healthy volunteers may be eligible.
You may be able to join if
- Cohorts 1 [NO FURTHER ACCRUAL], 2 [INACTIVE], 4 [NO FURTHER ACCRUAL] and 5 [INACTIVE]: Healthy Volunteers
- Males and females aged 18-50 years at time of initial protocol sampling
- people must participate fully and be willing to comply with the procedures of the protocol
- people must be co-enrolled in NIH protocol 08-HG-0059
- Ability of subject to understand and provide written informed consent
You likely can't join if
- Cohorts 1 [NO FURTHER ACCRUAL] and 2 [INACTIVE]: Healthy Volunteers
- Does not meet inclusion criteria
- Any female with symptoms and/or serum hormone levels consistent with perimenopause or menopause
- Use of systemic antibiotics in 12 months preceding baseline sampling
- Use of swimming pools, hot tubs, or whirlpools in 7 days preceding baseline sampling
- Use of topical or oral complementary/alternative medicine (CAM) agents within 4 weeks of initiation of treatment
See the full eligibility criteria
Who can join
- Cohorts 1 [NO FURTHER ACCRUAL], 2 [INACTIVE], 4 [NO FURTHER ACCRUAL] and 5 [INACTIVE]: Healthy Volunteers
- Males and females aged 18-50 years at time of initial protocol sampling
- people must participate fully and be willing to comply with the procedures of the protocol
- people must be co-enrolled in NIH protocol 08-HG-0059
- Ability of subject to understand and provide written informed consent
- Access to bathing facilities (Cohort 2 [INACTIVE])
- Ability to swallow capsules or tablets Cohort 3 [INACTIVE]: Atopic Dermatitis Patients
- people must be aged 2-50 years
- people must be co-enrolled in NIH protocol 08-HG-0059
- people must have a diagnosis of atopic dermatitis on the basis of the criteria defined by UK Working Party s Diagnostic Criteria for Atopic Dermatitis
- people must have a primary care provider
- people must have an Objective SCORAD (SCORing Atopic Dermatitis) of greater than or equal to 15 indicating AD severity of moderate to severe
- Prior to initiation of assigned by chance treatment, people must have signs of bacterial skin infections (skin weeping, crusting, and/or pustules)
- Access to bathing facilities
- All people and/or their Legally Authorized Representative (LAR) must have the ability and agree to participate fully and comply with the procedures of the protocol and provide informed consent. Pediatric patients will...
- people previously enrolled in Cohorts 1 [NO FURTHER ACCRUAL] and 4 [INACTIVE] who completed on-protocol antibiotic regimen
- people must participate fully and be willing to comply with the procedures of the protocol
- Ability of subject to understand and provide written informed consent
What rules you out
- Cohorts 1 [NO FURTHER ACCRUAL] and 2 [INACTIVE]: Healthy Volunteers
- Does not meet inclusion criteria
- Any female with symptoms and/or serum hormone levels consistent with perimenopause or menopause
- Use of systemic antibiotics in 12 months preceding baseline sampling
- Use of swimming pools, hot tubs, or whirlpools in 7 days preceding baseline sampling
- Use of topical or oral complementary/alternative medicine (CAM) agents within 4 weeks of initiation of treatment
- Known allergic reaction to sulfa, beta-lactam, or tetracycline class drugs; or lidocaine or epinephrine
- Family history of toxic epidermal necrolysis
- Known allergy or sensitivity to sodium hypochlorite (NaOCl)
- History of AD or asthma
- Inability to comply with the requirements of the protocol
- Pregnant or lactating
- people with a primary or acquired immunodeficiency, including HIV seropositiviy
- Any chronic past or present medical illness, including chronic skin diseases like psoriasis
- people receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants
- people who provide direct healthcare or reside in healthcare facilities or in non-hospital settings such as, assisted living facilities, homeless shelters, jails and prisons as well as people with frequent exposure to...
- Does not meet inclusion criteria
- Any female with symptoms and/or serum hormone levels consistent with perimenopause or menopause
- Known allergic reaction to beta-lactam class drugs, lidocaine, or epinephrine
- Family history of toxic epidermal necrolysis
- Known allergic reaction to sodium hypochlorite (NaOCl)
- Use of systemic antibiotics within 8 weeks, or topical antibiotics on intended sampling sites within 3 weeks, prior to baseline sampling
- Use of topical corticosteroids on all intended sampling sites within 7 days, prior to baseline sampling
- Use of topical or oral CAM agents within 4 weeks of initiation of treatment
- people with known primary or acquired immunodeficiency
- people with unstable or uncontrolled medical conditions that could require hospitalization during the initial month of the study or who have been hospitalized for treatment of these conditions in the one month prior to...
- people receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants within 7 days or 5 half-lives (whichever is the longer time period) of initiating...
- people who are currently receiving or have received chemotherapy or radiation for treatment of malignancies within the previous 6 months
- Pregnancy or lactating Cohorts 4 [NO FURTHER ACCRUAL] and 5 [INACTIVE]: Healthy Volunteers
- Does not meet inclusion criteria
- Any female with symptoms and/or serum hormone levels consistent with perimenopause or menopause
- Use of systemic antibiotics in 12 months preceding baseline sampling
- Use of swimming pools, hot tubs, or whirlpools in 7 days preceding baseline sampling
- Use of topical or oral complementary/alternative medicine (CAM) agents within 4 weeks of initiation of treatment
- (Cohort 4 [NO FURTHER ACCRUAL]) Known allergic reaction to sulfa class drugs; or lidocaine or epinephrine
- (Cohort 5 [INACTIVE]) Known allergic reaction to tetracycline class drugs; or lidocaine or epinephrine
- Family history of toxic epidermal necrolysis
- History of AD or asthma
- Inability to comply with the requirements of the protocol
- Pregnant or lactating
- people with a primary or acquired immunodeficiency, including HIV seropositivity
- Any chronic past or present medical illness, including chronic skin diseases like psoriasis
- people receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants
- people who provide direct healthcare or reside in healthcare facilities or in non-hospital settings such as assisted living facilities, homeless shelters, jails and prisons as well as people with frequent exposure to...
- Does not meet inclusion criteria
- Use of swimming pools, hot tubs, or whirlpools in 7 days preceding sampling
- Use of topical or oral CAM agents within 1 week or 4 weeks, respectively, prior to sampling
- Pregnant or lactating females in all cohorts are excluded from participating due to the potential effects of the above listed antimicrobials on the developing human fetus or nursing infant; listed in Sections 11.1...
- Smokers and people who use smokeless tobacco products are excluded in all cohorts due to tobacco s unknown impact on human oral mucosa and microflora.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.