All products were well tolerated, both alone and in combination.
Only one AE occurred during the study in a subject
receiving cleanser along with Flare Treatment. No AEs occurred
in subjects receiving cleanser and Body Cream.
These OTC formulations contain 1% colloidal oatmeal, licochalcone
A, and ceramide 3, and were developed to help restore
the acidic skin pH as well as to restore and maintain barrier
function. An acidic pH is essential to healthy skin, inhibiting
microbial growth and promoting the function of enzymes that
regulate desquamation and barrier lipid maturation.23,24 The
skin pH of children with AD has been demonstrated to be higher
relative to healthy counterparts,25 and reestablishing an acidic
skin environment is essential for repairing barrier function.
This study was the first randomized, controlled study testing the
efficacy and compatibility of Body Cream and Flare Treatment—2
products designed and formulated to treat eczema. This study was
limited by its small sample size, which may have influenced the
statistical analysis of cohorts that contained only a few subjects.
CONCLUSIONS
Few OTC eczema formulations have been evaluated in infants
and children as young as 3 months and demonstrated
efficacy and tolerability. The Body Cream and Flare Treatment
formulations offer parents/guardians and physicians efficacious
nonsteroidal, OTC treatment options specifically developed for
atopic skin. Results from this 3-phase study validate the use of
these products as an effective, first-line treatment regimen for
the management of AD, reducing the need for topical steroid
intervention. Although beyond the scope of this study, it can be
postulated that daily use of the Body Cream could reduce the
number of flares a child experiences over a period of years, and
could help reduce the need for, and cumulative exposure to,
topical steroid treatments.
AKNOWLEDGMENTS
The authors gratefully acknowledge the editorial contributions of
Jodie Macoun PhD, and the technical support of Craig E. Arrowitz.
DISCLOSURES
Teresa M. Weber PhD is an employee of Beiersdorf Inc, the manufacturer
of Eucerin® Eczema Relief Body Crème and Eucerin®
Eczema Relief Flare Treatment. Alexander Filbry PhD and Frank
Rippke MD are employees of Beiersdorf AG. Frank Samarin MD
and Michael J. Babcock MD have no conflicts of interest to declare.
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AUTHOR CORRESPONDENCE
Teresa M. Weber PhD……....................................... tweber@bdfusa.com