An RCT to determine an effective skin regime aimed at improving skin barrier function and quality of life in those with podoconiosis in Ethiopia.

Podoconiosis is a neglected tropical skin disease caused by a fault in skin barrier function (SBF) combined with a genetic predisposition. Irritant minerals and pathogens entering breaches in plantar skin cause an inflammatory reaction and lower leg lymphoedema. This has a considerable negative impact on the quality of life and economic status of some of the poorest people in 20 countries. Podoconiosis is preventable and treatable but not curable. No previous pre/post controlled intervention studies on skin treatment for the disease have been published. The aim of this randomised control trial (RCT) was to evaluate the effectiveness of a low-cost evidence-based skin care intervention to improve the SBF in the legs/feet and enhance disease related quality of life. A pilot study (n=10) indicated that adding 2% glycerine to the existing skin management regime used in Ethiopia could have a positive effect on stratum corneum (SC) hydration levels and trans-epidermal water loss (TEWL). The study recruited participants from two Ethiopian clinics (n=193). The control group used the existing treatment regime: washing legs/feet with soap, soaking in 6 litres of water with disinfectant added and applying Vaseline®. The experimental group added a 2% dilution of glycerine to 1/6 of the amount of soaking water and 0.0045% less disinfectant. After 3 months the experimental intervention had a highly significant positive effect on TEWL (p = < 0.001) and SC hydration (p = < 0.002) compared to the control. The reduction in foot circumference was highly significant (p = < 0.001). There was no significant group difference in Dermatology Life Quality Index (p = 0.907). The study indicates the very positive effect on SBF of adding 2% glycerine and less disinfectant to the current treatment. This finding offers a significant contribution to the body of knowledge on the management of the disease. The addition of 2% glycerine to treatment regimens may also have positive effects on other skin diseases with compromised SBF.