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

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 microl 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.