Phase 2 Eczema Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For healthy volunteers (some cohorts now closed or inactive — confirm current status with trial site):

• Adults between 18 and 50 years old at the time of first study samples are taken.
• People who are also enrolled in a related NIH study (protocol 08-HG-0059).
• People who are willing and able to follow all study procedures.
• People who are able to swallow capsules or tablets.
• People who are able to give written informed consent.
• People with access to bathing facilities (specific cohorts only — confirm with trial site).

For Cohort 6 (healthy volunteers — follow-up group):

• People who previously completed a specific antibiotic treatment as part of an earlier cohort in this same trial (Cohorts 1 or 4).
• People who are willing and able to follow all study procedures and give written informed consent.

For atopic dermatitis patients (this cohort is currently inactive — confirm with trial site):

• People between 2 and 50 years old.
• People who are also enrolled in the related NIH study (protocol 08-HG-0059).
• People who have a confirmed diagnosis of atopic dermatitis based on a specific set of recognised diagnostic criteria.
• People who have a regular primary care doctor or provider.
• People whose atopic dermatitis is rated as moderate to severe based on a standard scoring system (Objective SCORAD score of 15 or above).
• People who show signs of a bacterial skin infection (such as weeping, crusting, or pustules on the skin) before treatment begins.
• People who have access to bathing facilities.
• People (or their legal representative, for children) who are able to give informed consent; children will be included in age-appropriate discussions as required by NIH guidelines.

Who may not be able to join:

For healthy volunteers:

• Women who have symptoms or hormone levels suggesting they are approaching or have reached menopause.
• People who have used systemic (whole-body) antibiotics in the 12 months before the study begins.
• People who have used swimming pools, hot tubs, or whirlpools in the 7 days before the study begins.
• People who have used topical or oral complementary or alternative medicine products within 4 weeks of starting treatment.
• People with a known allergic reaction to certain antibiotic drug types (sulfa, beta-lactam, or tetracycline class drugs) or to lidocaine or epinephrine (confirm which apply to the relevant cohort with the trial site).
• People with a family history of a severe skin reaction called toxic epidermal necrolysis.
• People with a known allergy or sensitivity to sodium hypochlorite (a bleach solution).
• People with a personal history of atopic dermatitis or asthma.
• People who are unable to follow the study's requirements.
• People who are pregnant or breastfeeding.
• People with a primary or acquired immune system deficiency, including HIV.
• People with any ongoing or past chronic illness, including chronic skin conditions such as psoriasis.
• People who are currently receiving or planning to receive certain experimental treatments, ultraviolet light therapy, monoclonal antibodies, or medications that suppress the immune system.
• People who work directly in healthcare, live in healthcare facilities or settings such as assisted living facilities, homeless shelters, jails, or prisons, or who have frequent contact with laboratory animals.
• People who smoke or use smokeless tobacco products (excluded from all cohorts due to tobacco's unknown effects on the mouth and its natural bacteria).

For atopic dermatitis patients (inactive cohort — confirm with trial site):

• Women who have symptoms or hormone levels suggesting they are approaching or have reached menopause.
• People with a known allergic reaction to beta-lactam antibiotics, lidocaine, or epinephrine.
• People with a family history of toxic epidermal necrolysis.
• People with a known allergy to sodium hypochlorite.
• People who have used systemic antibiotics within 8 weeks, or topical antibiotics on the areas to be sampled within 3 weeks, before the study begins.
• People who have used topical corticosteroids on all areas to be sampled within 7 days before the study begins.
• People who have used topical or oral complementary or alternative medicine products within 4 weeks of starting treatment.
• People with a known primary or acquired immune system deficiency.
• People with unstable or poorly controlled medical conditions that might require hospitalisation during the first month of the study, or who have been hospitalised for such conditions in the month before the study begins.
• People who are currently receiving or planning to receive certain experimental treatments, ultraviolet light therapy, monoclonal antibodies, or immune-suppressing medications within 7 days or 5 half-lives of starting the study (whichever is longer — confirm with trial site).
• People who have received chemotherapy or radiation treatment for cancer within the previous 6 months.
• People who are pregnant or breastfeeding.

For Cohort 6 (healthy volunteers — follow-up):

• People who have used swimming pools, hot tubs, or whirlpools in the 7 days before sampling.
• People who have used topical complementary or alternative medicine products within 1 week, or oral complementary or alternative medicine products within 4 weeks, before sampling.
• People who are pregnant or breastfeeding (excluded across all cohorts due to potential effects of the study medications on a developing baby or nursing infant; people of childbearing potential must agree to use adequate contraception for the duration of the study).
• People who smoke or use smokeless tobacco products (excluded from all cohorts).

Important: Always verify eligibility with the trial site directly before applying.