Phase 2 Eczema Trial, Recruiting

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

Who might be able to join this trial:

• People aged 2 years or older at the time of giving consent to take part
• People who have been diagnosed with atopic dermatitis (eczema) using a recognised set of medical criteria, with a history of the condition lasting at least 6 months (or at least 3 months for children under 6)
• People whose eczema is rated as mild or moderate by a study doctor at both the screening visit and the first study day
• People who have eczema affecting the head (including face, but not the scalp where hair grows), neck, body (not including the groin or genitals), or limbs, covering between 2% and 20% of the body's total skin surface at screening and day one
• People who have at least one eczema patch measuring roughly 5 cm² or larger that is not on the hands, feet, or genitals, and is a good example of their eczema overall
• People whose eczema scores fall within a specific moderate range on a standard eczema severity measurement tool (EASI score between 3 and 21)
• People who rate their itch at 4 or higher out of 10 on a standard scale at screening and day one
• People who have been on a stable dose of any permitted medicines for at least 14 days before day one
• People who are willing to avoid using any topical products, including cosmetics and skin cleansers, on their eczema patches during the treatment period
• People who are willing and able to attend all scheduled visits and follow all study requirements
• Female participants who are not pregnant, not breastfeeding, and either cannot become pregnant or agree to use an approved method of contraception during the study; male participants who also agree to follow contraception guidance

Who may not be able to join:

• People whose eczema has been rapidly getting better or worse on its own in the 4 weeks before day one, as judged by the study doctor
• People who have another skin condition, significant scarring, or unusual skin pigmentation that could interfere with assessing their eczema or affect their safety
• People whose eczema only appears on the hands or feet, with no history of it appearing in other typical areas such as the face or skin folds
• People who have a type of atopic dermatitis other than the standard form being studied
• People currently using or expected to use other treatments that the study doctor believes could affect the course of their eczema
• People who have had UV light therapy or significant artificial UV exposure within 2 weeks before screening, or who plan to have such exposure during the study
• People who have recently used certain medicines that require a waiting period before joining, including: biologic medicines such as dupilumab (within the longer of 5 half-lives or 12 weeks); certain immune-suppressing medicines including oral steroids, cyclosporin, methotrexate, azathioprine, or similar drugs (within 4 weeks); systemic antibiotics (within 2 weeks); other topical eczema treatments apart from basic moisturisers, topical antiviral, antibacterial, antifungal, or steroid creams, or oral antibiotics (within 1 week)
• People who have been treated for cancer in the past 5 years, except for certain non-spreading skin cancers that have been fully removed or treated
• People who have another active or recurring skin condition, other than eczema, that could make it hard to assess results
• People who have had a serious, ongoing, or poorly controlled condition affecting the kidneys, liver, blood, digestive system, metabolism, hormones, lungs, heart, or nervous system within the past 3 months
• People who have been hospitalised for a body-wide infection in the past 3 months
• People who have needed intravenous or injected antimicrobials, antivirals, antifungals, or certain other injected medicines within the past 3 months
• People who have had major surgery or serious injury within 3 months before screening, or who have major surgery planned during the study
• People who have a known allergy to zabalafin or any ingredient in the study gel
• People who have depression that is not well controlled with medication, or who have severe depression or thoughts of self-harm (confirm with trial site)
• Female participants who test positive on a pregnancy test within 24 hours before being assigned to a treatment group
• People who have received a live or live-attenuated vaccine within 30 days before the first dose of the study treatment (certain approved COVID-19 vaccines may be permitted — confirm with trial site)
• People who are currently in another clinical trial or have taken an investigational medicine within 90 days or 5 half-lives (whichever is longer) before day one
• Staff members at the trial site who are directly involved in running the study, and their family members
• People who have had alcohol or substance misuse problems within 6 months before screening that the study doctor believes would interfere with participation
• People who have any medical or psychiatric condition that the study doctor or sponsor's medical monitor believes could put them at risk, or interfere with the study or its results

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