Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03742414 | Seal, Stopping Eczema and Allergy Study | PHASE2 | ACTIVE NOT_RECRUITING | 398 | — | — | Jun 30, 2021 | Jun 30, 2028 | Feb 27, 2026 | 5 | United States, United Kingdom |
Sensitization is defined as food-specific IgE \> 0.1 kU/L
| Arm | Type | Description |
|---|---|---|
| Control arm (Standard of care) | ACTIVE_COMPARATOR | The study doctors will provide standard of care with routine reactive topical products for atopic dermatitis flares |
| Active Intervention arm (proactive treatment)- Epiceram | EXPERIMENTAL | Participants will receive proactive sequential skin care with the twice-daily use of a tri-lipid skin barrier cream (SBC). Clinically apparent eczema in this group will be managed with a short course of topical steroids (fluticasone propionate cream and/or hydrocortisone). |
| Name | Type | Description |
|---|---|---|
| Tri-lipid skin barrier cream (Epiceram) | COMBINATION_PRODUCT | The aim is to compare the effect of proactive sequential skin care, including the twice daily use of a tri-lipid skin barrier cream (Epiceram) and proactive use of fluticasone proprionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA). |
| Fluticasone propionate Cream 0.05% | COMBINATION_PRODUCT | Proactive use of fluticasone proprionate cream for inflammation of the skin, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA). |
| Standard of Care | OTHER | Participants' eczema will be managed by their primary physician, i.e. standard of care with routine reactive topical products for atopic dermatitis flares. |
Inclusion Criteria: 1. Participants who develop early onset visible dry skin or atopic dermatitis up to and equal to 12 weeks of age. 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. In good general health as evidenced by medical history 4....