Efficacy and tolerability of pale sulfonated shale oil cream 4% in the treatment of mild to moderate atopic eczema in children: a multicentre, randomized vehicle-controlled trial

• Published in: Journal of the European Academy of Dermatology and Venereology Vol. 24; no. 10; pp. 1176 - 1182
• Main Authors: Korting, HC, Schöllmann, C, Cholcha, W, Wolff, L
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.10.2010
• Subjects: Administration, Topical; atopic eczema; Child; Child, Preschool; children; Dermatitis, Atopic - drug therapy; Dermatologic Agents - administration & dosage; Dermatologic Agents - adverse effects; Dermatologic Agents - therapeutic use; Dose-Response Relationship, Drug; Drug Tolerance; Emollients - administration & dosage; Emollients - adverse effects; Emollients - therapeutic use; Female; Humans; Infant; Male; pale sulfonated shale oil; Quaternary Ammonium Compounds - administration & dosage; Quaternary Ammonium Compounds - adverse effects; Quaternary Ammonium Compounds - therapeutic use; randomized controlled trial; Severity of Illness Index; Treatment Outcome
• ISSN: 0926-9959; 1468-3083
• DOI: 10.1111/j.1468-3083.2010.03616.x

Background  Reports on controlled trials on the efficacy and tolerability of sulfonated shale oils in atopic eczema are not available so far. The aim of this study was to investigate whether topically applied, specially prepared pale sulfonated shale oil (PSSO) cream is capable of improving symptoms/signs of mild to moderate atopic eczema in children more efficaciously than a corresponding vehicle cream. Patients and methods  A total of 99 children suffering from mild to moderate atopic eczema were enrolled in this multicentre, randomized, vehicle‐controlled study. Verum or vehicle cream was applied to the affected skin area three times a day over 4 weeks. As the primary outcome parameter served the reduction of the total score after 4 weeks of treatment, compared with the initial examination. Secondary outcome parameters were addressed as well. Tolerability was judged by investigators and patients/parents, and adverse events were documented. Results  After 4 weeks of treatment, the total score declined from 13.4 ± 3.7 to 4.5 ± 7.4 score points in the verum group and from 13.0 ± 3.1 to 11.7 ± 8.6 score points in the vehicle group (P < 0.0001). The superiority of verum regarding total score was already apparent after a treatment period of 1 week (reduction by 5.6 ± 4.3 vs. 1.3 ± 5.9 score points; P < 0.0001). Tolerability was found superior at the end of the treatment in the verum when compared with the control group – both by investigators (P < 0.0001) and patients/parents (P = 0.0051). Conclusion  Pale sulfonated shale oil cream 4% is capable to treat mild to moderate atopic eczema in children more efficaciously than vehicle and is well tolerated. PSSO thus represents a valuable addition to our therapeutic armamentarium. PSSO should be considered in particular when valid alternatives for topical glucocorticoids are sought for.