Bioequivalence in keratolytic activity of formulations vs its vehicle and comparator formulation: randomized, double-blind clinical trial.

This study assessed the bioequivalence, using keratolytic efficacy, of topical preparations studied in humans using adhesive tape stripping and biophysical methods. Ten healthy patients (3 men and 7 women [7 Caucasians and 3 Asians] mean age, 47 years) completed the study. Each coded product was randomly applied to the back according to the designated time of each sample. In addition, an untreated site (normal skin), and an untreated occluded site (chamber only) served as controls. At the end of the application time, each site was rinsed with tap water and then covered with a plastic chamber for 6 hours. Following removal of the chamber, the site was stripped for protein assay and squamometry analysis. This extends previous observations discerning bioequivalence resulting from different active materials with varying mechanism of action and potency on the skin. Results showed no significant difference between tested products. The novel formulations were of equal keratolytic activity to the "standard" (comparator) and hence bioequivalent in keratolytic activity.

Application of electrophoton capture (EPC) analysis based on gas discharge visualization (GDV) technique in medicine: a systematic review.

OBJECTIVES: The objective of this study was to evaluate the scale and scope of implementing electrophoton capture (EPC) analysis based on gas discharge visualization (GDV) technique in diverse medical applications and psychophysiology; to identify the range of applications in medicine; and to show in which areas the procedure can be useful to health professionals. DESIGN: The design of the study is a systematic review. METHODS: The database included articles published in peer-reviewed journals, proceedings of the international scientific congress "Science, Information, Spirit" (2003-2007), articles from the International Union of Medical and Applied Bioelectrography database, and proceedings of other conferences devoted to EPC or GDV, bioelectrography, and biophotonics. Search restrictions were human subjects, English or Russian language, and publication date from 2003 to 2007. All randomized controlled studies (RCTs) and systematic research reports (SRRs) were evaluated using Scottish Intercollegiate Guidelines Network and Jadad checklists. RESULTS: The search yielded 136 articles addressing four different fields of medical and psychophysiologic applications of EPC (GDV). Among them were 26 SRR, 19 RCT, 18 case reports or case series, and 13 cohort studies. Thirteen (13) RCTs and 19 SRRs were rated "high" on the two conventional checklists. CONCLUSIONS: (1) The software and equipment EPC/GDV-complex is a convenient and easy-to-use device, easily allows examining patients with various pathologies and, therefore, offers a wide range of applications. (2) The GDV method has shown itself to be very fast (i.e., it is an "express-method" for studying states of the human organism). (3) Our review has revealed that GDV method can be implemented as an express method for assessment of treatment procedure effectiveness, evaluating emotional and physical conditions of people, and in many other fields.