Phase 1 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:

• The participant (or their parent or legal guardian, if applicable) must be able to understand and agree to take part in the study.
• Participants must be male or female, aged 6 years or older.
• Participants must have been diagnosed with active atopic dermatitis (eczema) according to recognised standard diagnostic criteria.
• Participants must have at least 7 cm² of affected skin on the arms, legs, and/or trunk (areas such as the face, neck, hands, feet, and skin folds do not count toward this requirement).
• Participants must have eczema covering at least 3% of their total body surface area, as measured during a standard eczema severity assessment.
• Participants must have a disease severity score of 2 or higher on a standard clinical rating scale (confirm with trial site).
• Participants who are able to become pregnant must either be willing to avoid sexual activity that could result in pregnancy, or be willing to use an FDA-approved form of contraception throughout the study — including options such as permanent sterilisation of a partner, long-acting devices (e.g., IUDs or implants used for at least 7 days before the baseline visit), short-acting hormonal methods (e.g., the pill, patch, or ring used for at least 30 days before the baseline visit), or barrier methods (e.g., condoms, diaphragm with spermicide).
• Participants who are able to become pregnant must have received negative pregnancy test results at both the screening and baseline visits.

Who may not be able to join:

• People who are unable or unwilling to give written consent or follow the study requirements.
• People who are currently pregnant or breastfeeding, or who have a positive pregnancy test at screening or baseline.
• People who have a known sensitivity or intolerance to any of the following products used in the study: Dove® fragrance-free bar soap, Cetaphil® lotion, alcohol-based cleansers, certain steroid ointments (clobetasol, fluocinonide, triamcinolone, hydrocortisone), glycerol, hydroxyethylcellulose, or soy products.
• People whose eczema has not responded to strong topical steroid treatments within the past 6 months.
• People with a history of a serious or life-threatening reaction to tape or adhesives.
• People with a known allergy to all antibiotics in a specific list of medications to which the study bacteria (S. hominis A9) are sensitive (confirm full antibiotic list with trial site).
• People with a major skin barrier condition such as open wounds or certain rare inherited skin disorders (e.g., Netherton's syndrome).
• People with a weakened immune system (e.g., due to HIV/AIDS or certain immune disorders) or an autoimmune disease.
• People with an active cancer diagnosis, except for certain non-melanoma skin cancers in areas not involved in the treatment.
• People with a history of psychiatric illness, or alcohol or drug misuse, that the study investigator believes could affect their ability to follow the study protocol.
• People currently taking part in another clinical trial, or who have taken an experimental drug within 8 weeks (or five half-lives, whichever is longer) before screening.
• People who have been treated with non-steroid immune-suppressing medicines in the 6 months before screening.
• People who have received a biologic medication (including dupilumab) within 16 weeks before screening.
• People who have taken oral or injectable eczema treatments (other than oral steroids) within 16 weeks or five half-lives before screening, whichever is longer.
• People who have used oral retinoid medications (e.g., isotretinoin) within 60 days before screening.
• People who have undergone allergy immunotherapy within 30 days before screening.
• People who live with or have close contact with individuals who have severe skin barrier problems or weakened immune systems (e.g., a spouse, child, or household member).
• People who, in the investigator's opinion, may have difficulty stopping their usual topical eczema treatments, prescription moisturisers, antibiotics, oral steroids, or light therapy in preparation for the baseline visit.
• People with any other medical condition or finding that the investigator believes could increase their risk, affect their ability to follow the study, or affect the reliability of the results.
• People whose eczema covers more than 30% of their total body surface area at the baseline visit.
• People with an active bacterial, viral, or fungal skin infection at baseline (with the exception of certain nail or foot fungal infections).
• People with significant breaks, cracks, open wounds, or weeping skin in the areas where the study product would be applied, particularly if these suggest an active infection (minor breaks in areas not used for sampling may be considered at the investigator's discretion).
• People who have used topical eczema treatments — including steroids or calcineurin inhibitors — on the arms, legs, or trunk within 7 days before the baseline visit.
• People who have used prescription medical-device moisturisers (e.g., Atopiclair®, MimyX®, Epicream®) on the arms, legs, or trunk within 7 days before the baseline visit.
• People who have used any antibiotic, antifungal, antiparasitic, or antiviral medicine — either systemically or topically on the arms, legs, or trunk — within 14 days before the baseline visit (certain antiviral medicines may be permitted with approval from the study team).
• People who have used any topical product not specified by the study protocol on the arms, legs, or trunk within 7 days before the baseline visit.
• People who have used systemic (oral or injected) corticosteroids for any reason within 28 days before the baseline visit.
• People who have used systemic corticosteroids to treat an asthma flare-up within 3 months before the baseline visit.
• People who require high-dose inhaled corticosteroids (above a specified threshold) to control their asthma at the time of the baseline visit (confirm threshold with trial site).
• People who have received any light-based skin therapy (e.g., UVB, UVA1, PUVA) or who regularly use a tanning bed (more than twice a week) within 28 days before the baseline visit.

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