Safety Evaluation of Budesonide Cream in Normal Volunteers Comparative Study with Difluprednate and Dexamethasone Propionate Cream

• Published in: Skin research Vol. 32; no. 5; pp. 684 - 689
• Main Author: SUGAI, Tetsuro
• Format: Journal Article
• Language: English
• Published: Meeting of Osaka Dermatological Association 1990
• Subjects: budesonide cream; dexamethasone propionate cream; difluprednate cream; safety evaluation
• ISSN: 0018-1390; 1884-541X
• DOI: 10.11340/skinresearch1959.32.684

To evaluate systemic and topical effects of 0.05% budesonide (BUD) cream, three groups of 16 healthy male volunteers were treated for three consecutive days with 0.05% BUD cream, 0.05% difluprednate (DFP) cream and 0.1% dexamethasone propionate (DDP) cream, respectively. Daily applications of 10g of each cream in the respective group was performed under occlusive dressing technique for 14 hours a day. The serum levels of cortisol were measured every morning before and during the first three days of treatment and also the following three days of observation. Eosinophils counts and blood glucose levels were also measured. Serum levels of cortisol was lowered in BUD and DDP on the second and third day of treatment significantly (BUD: p<0.05, DDP: p<0.01), and the suppression was recovered at the first day of observation. On the other hand, no significant changes of serum cortisol levels were found in DFP because of large variability, but a significant increase of mean value of serum cortisol was seen in DFP over the normal upper limit on the first day of observation. The number of eosinophils was significantly decreased just on the third day of treatment in DFP and DDP (p<0.05), while no significant changes in BUD. Level of blood glucose was significantly elevated on the third day of treatment and also on the third day of observation in DFP and DDP (p<0.01), but no significant difference was found in BUD. The number of reddish papules was decreased during the treatment in the whole groups, but increased on the third day of observation in DFP, DDP and BUD in order. Thus, comedogenic effects of BUD is considered weaker than those of DFP and DDP.