BACKGROUND/AIMS: Topical glucocorticoids with improved benefit/risk ratio are of great interest in dermatology, but there are very few trials directly comparing the efficacy and side-effects of these new preparations. In our study the vasoconstrictor effect and side-effects of two of these new glucocorticoids were evaluated and blanching effect was determined by two-dimensional laser scanning. METHODS: In a randomised, double blind intra-individual comparative trial, 10 subjects were treated withvarious glucocorticoids or drug-free vehicle. The test drugs were mometasone furoate (MF), methylprednisolone aceponate (MP) and hydrocortisone (OH-C). The preparations were tested for a period of 3 weeks with occlusion on the flexor side of the forearm. Skin thickness and vasoconstriction were determined using 20 MHz ultrasound scanning, laser Doppler scanning (LDS) and chromometry. RESULTS: No adverse effects were observed during the observation period. Only partial vasoconstriction occurred in most cases during the observation period. MP and MF produced maximal blanching between days 3 and 5 of treatment, while with OH-C clinically visible blanching did not occur. Ultrasound evaluation of skin thickness showed similar behaviour for all three steroids tested: there were no signs of skin atrophy in any of the cases. LDS evidenced hypoperfusion of a test area on the perfusion image in only a few patients and there were no significant differences between the steroids tested. On evaluation of vasoconstriction caused by the steroids tested using chromometry there was a significant difference between MF and OH-C on the L*a*b* scale (P < 0.005). Only at day 3 was a blanching effect caused by MP and MF demonstrable (a-value, P < 0.05). CONCLUSION: In summary, the synthetic steroids MF and MP presented side-effects similar to those of OH-C but much greater vasoconstrictor effect; after an application period of over 5 days under occlusion a blanching effect in our model was not demonstrable by means of chromometry. Two-dimensional laser scanning offers no advantage in the evaluation of the blanching effect in comparison to one-dimensional laser fluxmetry (LDF).
RCT Entities:
BACKGROUND/AIMS: Topical glucocorticoids with improved benefit/risk ratio are of great interest in dermatology, but there are very few trials directly comparing the efficacy and side-effects of these new preparations. In our study the vasoconstrictor effect and side-effects of two of these new glucocorticoids were evaluated and blanching effect was determined by two-dimensional laser scanning. METHODS: In a randomised, double blind intra-individual comparative trial, 10 subjects were treated with various glucocorticoids or drug-free vehicle. The test drugs were mometasone furoate (MF), methylprednisolone aceponate (MP) and hydrocortisone (OH-C). The preparations were tested for a period of 3 weeks with occlusion on the flexor side of the forearm. Skin thickness and vasoconstriction were determined using 20 MHz ultrasound scanning, laser Doppler scanning (LDS) and chromometry. RESULTS: No adverse effects were observed during the observation period. Only partial vasoconstriction occurred in most cases during the observation period. MP and MF produced maximal blanching between days 3 and 5 of treatment, while with OH-C clinically visible blanching did not occur. Ultrasound evaluation of skin thickness showed similar behaviour for all three steroids tested: there were no signs of skin atrophy in any of the cases. LDS evidenced hypoperfusion of a test area on the perfusion image in only a few patients and there were no significant differences between the steroids tested. On evaluation of vasoconstriction caused by the steroids tested using chromometry there was a significant difference between MF and OH-C on the L*a*b* scale (P < 0.005). Only at day 3 was a blanching effect caused by MP and MF demonstrable (a-value, P < 0.05). CONCLUSION: In summary, the synthetic steroidsMF and MP presented side-effects similar to those of OH-C but much greater vasoconstrictor effect; after an application period of over 5 days under occlusion a blanching effect in our model was not demonstrable by means of chromometry. Two-dimensional laser scanning offers no advantage in the evaluation of the blanching effect in comparison to one-dimensional laser fluxmetry (LDF).