Inflammation Research

, Volume 47, Issue 2, pp 75–78

Anti-inflammatory action of pale sulfonated shale oil (ICHTHYOL pale) in UVB erythema test

  • J. Warnecke
  • A. Wendt

DOI: 10.1007/s000110050282

Cite this article as:
Warnecke, J. & Wendt, A. Inflamm. res. (1998) 47: 75. doi:10.1007/s000110050282


Objective and Design: In a clinical research institute the anti-inflammatory effect of pale sulfonated shale oil versus hydrocortisone was investigated in a placebo-controlled clinical trial using a double-blind design and random assignment of the treatments to the test fields.¶Subjects: 20 male and female volunteers with healthy skin in the test areas participated in this trial.¶Treatment: All subjects received different concentrations of pale sulfonated shale oil (2% and 4%), the active ingredient-free vehicle and a reference product containing 0.5% hydrocortisone.¶Methods: Approximately 300 μl of test preparation were applied to the treatment fields. The medication was administered for 23 h. An untreated, irradiated and an untreated, non-irradiated control field were included as well. The test fields were compared intraindividually. Four different UV-doses (1; 1.25 ; 1.6 and 2 MED) were tested in each volunteer. The test fields were occluded for 6 h. After 7 h, measurement with a colorimeter was carried out. After measurement, the treatment was repeated. The test fields were occluded for a further 16 h and test preparations carefully wiped off. One hour later, post-irradiation color measurements were made by colorimetric detection. Variance analysis was used for statistical evaluation.¶Results: 4% pale sulfonated shale oil and 0.5% hydrocortisone had a significantly greater efficacy than the vehicle (p = 0.0001). There were no differences between the efficacy of 4% pale sulfonated shale oil and 0.5% hydrocortisone (p = 0.5169).¶Conclusions: These results demonstrate the anti-inflammatory efficacy of 4% pale sulfonated shale oil and help explain the clinical effects of the drug in the therapy of atopic eczema.

Key words: Antiphlogistic — Clinical trial — Hydrocortisone — Pale sulfonated shale oil (PSSO) — UVB erythema test 

Copyright information

© Birkhäuser Verlag, Basel 1998

Authors and Affiliations

  • J. Warnecke
    • 1
  • A. Wendt
    • 2
  1. 1.Dorfstr. 6, D-25560 Oldenborstel, Germany, Fax +49 405 0714 110DE
  2. 2.Reimanstr. 26, D-52070 Aachen, GermanyDE

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