Effects of Treatments on Atopic Dermatitis

• 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 theprotocol

• 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 criteriadefined 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 thanor equal to 15 indicating AD severity of moderate to severe

• Prior to initiation of randomized treatment, subjects must have signs of bacterialskin infections (skin weeping, crusting, and/or pustules)

• Access to bathing facilities

• All subjects and/or their Legally Authorized Representative (LAR) must have theability 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] whocompleted on-protocol antibiotic regimen

• Subjects must participate fully and be willing to comply with the procedures of theprotocol

• 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 perimenopauseor 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 4weeks of initiation of treatment

• Known allergic reaction to sulfa, beta-lactam, or tetracycline class drugs; orlidocaine 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 likepsoriasis

• 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 innon-hospital settings such as, assisted living facilities, homeless shelters, jailsand 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 perimenopauseor 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 intendedsampling sites within 3 weeks, prior to baseline sampling

• Use of topical corticosteroids on all intended sampling sites within 7 days, priorto 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 requirehospitalization during the initial month of the study or who have been hospitalizedfor 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 fortreatment 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 perimenopauseor 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 4weeks of initiation of treatment

• (Cohort 4 [NO FURTHER ACCRUAL]) Known allergic reaction to sulfa class drugs; orlidocaine or epinephrine

• (Cohort 5 [INACTIVE]) Known allergic reaction to tetracycline class drugs; orlidocaine 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 likepsoriasis

• 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 innon-hospital settings such as assisted living facilities, homeless shelters, jailsand prisons as well as subjects with frequent exposure to laboratory animals

Cohort 6: Healthy Volunteers

• 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 tosampling

• Pregnant or lactating females in all cohorts are excluded from participating due tothe potential effects of the above listed antimicrobials on the developing humanfetus or nursing infant; listed in Sections 11.1 through 11.5. Females ofchildbearing potential must agree to use adequate contraception (hormonal or barriermethod of birth control; abstinence) prior to study entry and for the duration ofstudy participation. Should a woman become pregnant or suspect she is pregnant whileshe is participating in this study, she should inform her treating physicianimmediately. Lactating mothers will discontinue breastfeeding prior to studyenrollment.

• Smokers and subjects who use smokeless tobacco products are excluded in all cohortsdue to tobacco s unknown impact on human oral mucosa and microflora.