Seal, Stopping Eczema and Allergy Study

Kari Nadeau, MD, PhD

Status and phase: Enrolling; Phase 2

Conditions: Atopic Dermatitis; Atopic Dermatitis Eczema; Eczema, Infantile; Eczema

Treatments: Combination Product: Fluticasone propionate Cream 0.05%; Combination Product: Tri-lipid skin barrier cream (Epiceram); Other: Standard of Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03742414

48199

1U01AI147462-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This is a randomized, controlled trial designed for children who are have already developed atopic dermatitis (AD or eczema) by 12 weeks of age. 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 propionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).

Full description

This is a randomized, controlled, parallel design, open-label phase 2 clinical study to compare the efficacy of a proactive treatment arm versus the reactive arm, for the prevention of atopic dermatitis in children at high risk of food allergy. We will recruit 312 infants who have signs of dry skin or atopic dermatitis between 0-12 weeks of life.

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 propionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).

Enrollment: 312 estimated patients

Sex: All

Ages: 1 to 12 weeks old

Volunteers: No Healthy Volunteers

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. No known adverse reaction to any of the study medications, their components or excipients

Exclusion criteria

1. Infants <3kg body weight
2. Infants with a chronic disease requiring therapy (e.g. heart disease, diabetes, serious neurological defects, immunodeficiency)
3. Known moderate to severe cutaneous skin disorder other than AD, including but not limited to cutaneous mastocytosis, bullous skin disease, pustular skin disease, neonatal HSV, aplasia, and albinism
4. Parents or guardians unwilling to sign consent
5. Current participant or participation since birth in any interventional study
6. Investigator or designee considers that the participant or parent/guardian would be unsuitable for inclusion in the study (for ex/ long stay in NICU)
7. A course of antibiotics in infant within 7 days of enrollment
8. Any known food allergies

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

312 participants in 2 patient groups

Control arm (Standard of care)

Active Comparator group

Description:

The study doctors will provide standard of care with routine reactive topical products for atopic dermatitis flares

Treatment:

Other: Standard of Care

Active Intervention arm (proactive treatment)- Epiceram

Experimental group

Description:

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).

Treatment:

Combination Product: Tri-lipid skin barrier cream (Epiceram)

Combination Product: Fluticasone propionate Cream 0.05%