Phase 2 study to assess topical product in preventing infant eczema

PuraCap Pharmaceutical has announced its participation in a phase 2 trial to assess daily treatment of its topical ceramide-dominant complete lipid mixture to prevent eczema in infants at risk for allergic conditions.

The Australian PEBBLES trial is expected to recruit 100 infants with first-degree histories of allergic disease, including eczema, asthma or food allergy, according to a press release. The infants will receive either twice-daily EpiCeram Controlled Release Skin Barrier Emulsion or be assigned to a control group, with a clinical outcome assessor masked to the groups.

Skin barrier function will be measured at 6 weeks, 6 months and 12 months of age. Eczema incidence and allergic sensitization at 6 and 12 months and skin barrier function at 6 weeks and 6 months are the primary endpoints.

The trial is based on a pilot study of 10 at-risk infants from birth to 4 weeks of age who received EpiCeram for 6 weeks. Clinical results supported the safety and parental compliance with daily application for preventing eczema, according to the release.

“We have designed this phase 2 trial to provide the data necessary to validate that a novel lipid-rich replenishing agent can restore skin barrier function in newborns, and thereby prevent the onset of eczema and progression to other allergic diseases,” researcher Adrian J. Lowe, PhD, of the Murdoch Children’s Research Institute in Australia, said in the release.

Precluding eczema and atopic dermatitis in infants could help “atopic march,” the progression of allergic disease manifested by eczema, followed by food allergy, allergic rhinitis and asthma, according to the release.

Updates on EpiCeram will be presented at the American Academy of Dermatology annual meeting March 21-25 in Denver, PuraCap announced.