Efficacy of urea therapy in children with ichthyosis. A multicenter randomized, placebo-controlled, double-blind, semilateral study.
BACKGROUND
Ichthyoses are genetic disorders of keratinization which are uncomfortable due to their conspicuous scaling, itching and cosmetic problems. Especially in childhood, ichthyoses can lead to social discrimination and psychological problems. Efficient therapies are necessary which are safe and well tolerated.


OBJECTIVE
The aim of the study was to investigate the keratolytic and moisturizing properties as well as the tolerance of a new urea lotion when applied to hyperkeratotic and ichthyotic skin in childhood.


METHODS
The study was conducted as a multicenter, randomized, placebo-controlled, double-blind, semilateral investigation. Sixty children between 1 and 16 years treated one side of the most affected extremity with Laceran 10% urea lotion for 8 weeks. On the other side the urea-free Laceran lotion base was given. On each side of the body a control area was left untreated. The investigators evaluated the global severity of ichthyotic symptoms with the help of a visual analogue scale.


RESULTS
The analysis of the global estimation of severity of ichthyosis showed improvements being stronger in the body areas treated with Laceran 10% urea lotion (from 4.8 to 2.0 points) than in the areas treated with the urea-free Laceran lotion base (from 4.8 to 2.5 points). The response rates were 65% after 4 weeks and 78% after 8 weeks for Laceran 10% urea lotion, 50% after 4 weeks and 72% after 8 weeks for the urea-free Laceran lotion base.


CONCLUSIONS
It can be ascertained that Laceran 10% urea lotion has a strong positive effect on generalized ichthyotic keratinization disorders.
Küster
W
W
TOMESA Clinic of Dermatology, Bad Salzschlirf, Germany.
Bohnsack
K
K
Rippke
F
F
Upmeyer
H J
HJ
Groll
S
S
Traupe
H
H
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003877:Dermatitis, Contact / Q000209:etiology; D017453:Dermatitis, Irritant / Q000209:etiology; D004311:Double-Blind Method; D004890:Erythema / Q000139:chemically induced; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007057:Ichthyosis / Q000188:drug therapy* / Q000503:physiopathology; D007073:Immunoglobulin E / Q000187:drug effects / Q000378:metabolism; D007223:Infant; D008297:Male; D009824:Ointments; D010919:Placebos; D011537:Pruritus / Q000139:chemically induced; D012720:Severity of Illness Index; D012871:Skin Diseases / Q000188:drug therapy / Q000473:pathology; D018709:Statistics, Nonparametric; D013997:Time Factors; D016896:Treatment Outcome; D014508:Urea / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D009824:Ointments; D010919:Placebos; D007073:Immunoglobulin E; D014508:Urea