Phase 2 Vitiligo 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:

• Children and teenagers aged 2 years old up to (but not including) 18 years old
• A parent or legal guardian must give consent for the child to participate, and older children should also agree to join if required by local rules
• The child has been diagnosed with a specific type of vitiligo called "non-segmental vitiligo" for at least 3 months, confirmed by a skin doctor
• Less than 10% of the child's total body skin is affected by vitiligo, AND at least a small area of the face (0.5% of body surface) is affected, AND some of the vitiligo patches on the face still have normally coloured hair growing in them
• The child is considered to be in good overall health based on their medical history and a physical examination
• The parent/guardian and child are able and willing to follow all study requirements and attend all scheduled visits

Who may not be able to join:

• Children with a serious medical condition or abnormal physical examination result that would make participation unsafe, as decided by the study doctor
• Children with known or suspected severe kidney problems or moderate to severe liver disease
• Children who cannot stop certain medications or treatments before and during the study — including biologic or experimental therapies (stopped at least 12 weeks before), light/UV therapy (stopped at least 4 weeks before), immune-modifying treatments (stopped at least 4 weeks before), or skin-applied treatments (stopped at least 1 week before)
• Children who are unwilling to avoid tanning beds or artificial light devices for 4 weeks before the study starts and throughout the study
• Children diagnosed with other types of vitiligo (such as segmental vitiligo) or other skin conditions that cause loss of skin colour (such as certain fungal infections, post-inflammatory skin changes, or others), which could interfere with study results
• Children with a known genetic skin condition that overlaps with non-segmental vitiligo
• Children with a known allergy to any of the ingredients in the study foam medication (confirm with trial site for full ingredient list)
• Children who cannot stop taking certain medications that affect how the body processes drugs (specific enzyme inhibitors — confirm with trial site)
• Children who have taken oral roflumilast tablets within the 4 weeks before the study starts
• Females who are pregnant, planning to become pregnant, or currently breastfeeding
• Children who have previously been treated with roflumilast cream or foam for vitiligo in the past 3 months
• Children whose parent/guardian cannot communicate, read, or understand the local language, or children who cannot do so themselves, or who have any other condition making participation unsuitable in the study doctor's opinion
• Children who are family members of the study site staff, study team, or study sponsor, or who live in the same home as another child already enrolled in the trial

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