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.

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.

[Anti-inflammatory, antibacterial and antimycotic effects of dark sulfonated shale oil (ichthammol)]. / Zur antientzündlichen, antibakteriellen und antimykotischen Wirkung von dunklem sulfonierten Schieferöl (Ichthammol).

Dark sulfonated shale oil (Ichthammol, ammoniumbituminosulfonate) is an active ingredient of natural origin that was included in Annex II of European Council Regulation (EEC) 2377/90. Therefore, this well-tolerated substance is available further on as a dermatological agent for the application to animals from which food is produced for human consumption. The manifold pharmacological actions could be substantiated in numerous in-vitro studies using the Ichthammol from Seefeld, Austria. The antiinflammatory action which is well-known from clinical experience could be traced back to an influence of the substance on the formation, secretion and effect of inflammation mediators. Antibacterial and antimycotic actions which are well-known from clinical use could be confirmed in in-vitro studies as well.

[The adverse effects of dark sulfonated shale oil following local and systemic administration]. / Untersuchungen zur Verträglichkeit von dunklem sulfoniertem Schieferöl nach lokaler und systemischer Applikation.

Ichthyol (Ammoniumbituminosulfonat DAB, dark sulfonated shale oil, CAS 8029-68-3) is used for the treatment of inflammatory skin diseases and rheumatic diseases and blunt traumata. The studies conducted were carried out to obtain information on the risk following dermal and oral application of dark sulfonated shale oil. Corresponding to the administration route envisaged for man the drug was applied by topical and systemic administration. Studies were conducted on the acute, subacute and chronic toxicity, local tolerance, and the teratogenic, mutagenic and carcinogenic potential. Dark sulfonated shale oil was found to be well tolerated whether administered for a short period or over a long time. There were no indications for a teratogenic, mutagenic or carcinogenic effect. The therapeutic index (ratio of the toxic dose in animals and the therapeutic human dose) for topical administration of dark sulfonated shale oil is > 7 depending on animal species, frequency of administration, dose-level employed and the toxicological question posed. The results of the toxicological studies coincide with more than 110 years of experience that the drug is well-tolerated by man.

[The tolerability of pale sulfonated shale oil following local and systemic administration]. / Untersuchungen zur Verträglichkeit von hellem sulfoniertem Schieferöl nach lokaler und systemischer Applikation.

Ichthyol, pale, a pale sulfonated shale oil, is used for the treatment of inflammatory skin diseases. The studies conducted were carried out to obtain information on the risk following dermal application of sulfonated shale oil, pale. Corresponding to the administration route planned for man the drug was applied by topical and systemic administration. Studies were conducted on the acute, subacute and chronic toxicity, and the teratogenic, mutagenic and carcinogenic potential. Sulfonated shale oil, pale was found to be very well tolerated whether administered for a short period or over a long time. There were no indications for teratogenic, mutagenic or carcinogenic effects. The therapeutic range (ratio of the toxic dose in animals and the therapeutic human dose) for topical administration is > 30 depending on animal species, frequency of administration, dose-level employed and the toxicological question posed. The results of the toxicological studies coincide with the almost 70 years of experience that the drug is well-tolerated by man.