Lichen sclerosus et atrophicans in men: clinical efficacy of hydrobiont collagenase isoenzymes electrophoresis in the rehabilitation phase

BACKGROUND: In view of the lacking ineffectiveness of the currently established treatment methods of men with genital lichen sclerosus (GLS), as well as the lack of evidence-based ways of managing patients at the rehabilitation stage, there exists a want for new approaches to solve this problem.

AIMS: The aim of the research was to study the possibility of applying electrophoresis of an enzyme preparation from hydrobiont collagenases at the stage of rehabilitation in men with GLS.

MATERIAL AND METHODS: Open-label randomized controlled trial comparing clinical efficacy of hydrobiont enzyme preparation and standard supportive emollient therapy at the stage of rehabilitation in men with confirmed GLS was conducted. The follow-up period lasted for 16 weeks. Clinical efficacy was estimated using specifically developed scores LS-S (surface area), LS-A (disease activity) and validated dermatologic life quality index (DLQI) at 6^th and 16^th week of follow-up. The primary study outcome was the comparative efficacy at 16^th week as based on the evaluated scores.

RESULTS: All patients (n=27) were given topical glucocorticoids (TGCs) at the first stage of the study during the first 6 weeks. The patients were then randomly allocated into 2 groups for the rehabilitation stage that lasted from 6^th to 16^th week of the study. The first group (primary group, n=13) were managed with electrophoresis of an enzyme preparation from hydrobiont collagenases. The second group (control group, n=14) were managed with emollients at the rehab stage. The age of patients in the first group and in the second group was 36,62±16,04 and 41,93±9,34 years, respectively. At baseline before initiating treatment patients in both groups as judged by LS-S (p=0,110), LS-A (p=0,757) и DLQI (p=0,149) comparable. At 6^th week after course of TGCs no statistically significant differences were detected. At the primary study outcome at 16^th week scores LS-S (p=0,002), LS-A (р <0,001) and DLQI (р <0,001) evidenced significantly in favour of enzyme electrophoresis.

CONCLUSION: During staged treatment, a more pronounced and long-lasting effect was observed in the group of patients with electrophoresis of the enzyme complex during the rehabilitation stage compared to the group with emollients