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โ† Trials
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Effects of Treatments on Atopic Dermatitis

RecruitingPhase 2Ages 2 Years - 50 YearsAllNational Institute of Arthritis and Musculoskeletโ€ฆ
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In plain words

What the trial is, and whether it could suit you

Background: \- Atopic dermatitis, or eczema, is a chronic skin disorder. Patients sometimes have infections with S. aureus bacteria. Researchers want to study how eczema treatments affect the number and the type of bacteria on the skin. Objectives: \- To study the effect of eczema treatments on skin bacteria. Eligibility: * Individuals between 2 and 25 years of age who have moderate to severe atopic dermatitis. * Healthy volunteers between 18 and 40 years of age with no history of eczema. Design: * Participants will be screened with a physical exam and medical history. Research samples will be collected. Skin biopsies may also be performed. * All participants will be assigned to one of several study groups. * Healthy volunteers must not have taken antibiotics in the year before the start of the study. * All participants will have regular study visits during their 1-year participat

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
* INCLUSION CRITERIA: 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 * Subjects must participate fully and be willing to comply with the procedures of the protocol * Subjects 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 * Subjects must be aged 2-50 years * Subjects must be co-enrolled in NIH protocol 08-HG-0059 * Subjects must have a diagnosis of atopic dermatitis on the basis of the criteria defined by UK Working Party s Diagnostic Criteria for Atopic Dermatitis * Subjects must have a primary care provider * Subjects 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 randomized treatment, subjects must have signs of bacterial skin infections (skin weeping, crusting, and/or pustules) * Access to bathing facilities * All subjects 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 be included in age appropriate discussions and age appropriate assent will be obtained in accordance with NIH guidelines. -Ability of subject to understand and provide written informed consent Cohort 6: Healthy Volunteers * Subjects previously enrolled in Cohorts 1 \[NO FURTHER ACCRUAL\] and 4 \[INACTIVE\] who completed on-protocol antibiotic regimen * Subjects must participate fully and be willing to comply with the procedures of the protocol * Ability of subject to understand and provide written informed consent EXCLUSION CRITERIA: 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 * Subjects with a primary or acquired immunodeficiency, including HIV seropositiviy * Any chronic past or present medical illness, including chronic skin diseases like psoriasis * Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants * Subjects 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 subjects with frequent exposure to laboratory animals Cohort 3 \[INACTIVE\]: Atopic Dermatitis Patients * 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 * Subjects with known primary or acquired immunodeficiency * Subjects 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 baseline sampling * Subjects 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 treatment on this protocol * Subjects 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 * Subjects with a primary or acquired immunodeficiency, including HIV seropositivity * Any chronic past or present medical illness, including chronic skin diseases like psoriasis * Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants * Subjects who provide direct healthcare or reside in healthcare facilities or in non-hospit
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What it tests

  • Trimethoprim/sulfamethoxazole (TMP/SMZ)
  • Cephalexin
  • Doxycycline
  • Sodium hypochlorite
  • Placebo capsules
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Where

1 site
National Institutes of Health Clinical Center
Bethesda, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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