Non-filarial Elephantiasis Clinical Trial
Official title:
A Randomised Controlled Trial to Evaluate the Effect of a New Skin Care Regimen on Skin Barrier Function in Those With Podoconiosis in Ethiopia
An RCT in two podoconiosis clinics in Ethiopia to evaluate the effectiveness of the addition of 2% glycerine to the current skin care regimen
Background. Podoconiosis (non-filarial elephantiasis) affects some of the poorest people in
20 countries in the world. In Ethiopia least 3 million people are affected with 17 million
at risk. Irritant minerals (smectite, mica and quartz) from volcanic soil and pathogens
enter skin breaches in the feet causing inflammation, lymphoedema and hyperkeratosis.
Podoconiosis is preventable and treatable but is not curable. Current treatment consists of
educating those with disease on its causes, prevention and treatment. Treatment taught in
the Action on Podoconiosis (APA) Clinics consists of a daily hygiene regimen of washing the
feet/legs with soap, soaking the feet and legs in water with sodium hypochlorite (NaOCI)
(0.0125%) added as a disinfectant, air drying and the application of a thin layer of
petrolatum jelly. Whitfields ointment (benzoic acid and salicylic acid) is applied to any
fungal infections. Wearing shoes is encouraged but this does not offer complete protection
against the alkaline soil.
Although the current treatment skin care regimen is effective there is no robust evidence on
optimal skin care regimens to improve skin barrier function in this disease.
Objective. To evaluate the effectiveness of a new, low-cost, evidence-based skin care
intervention to improve SBF in the lower limbs of those with podoconiosis.
Method. A randomized control trial (RCT) was conducted over 3 months in two APA Clinics
(n=193). Intervention was 2% glycerine (v/v) added to a reduced amount of soaking water (1
litre versus 6 litres). The control group received the current skin care regimen. The
primary outcome measure was skin barrier function (SBF). This was determined by measures of
trans-epidermal water loss (TEWL) and stratum corneum hydration (SCH) at four specific sites
on the lower limbs.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01160523 -
Promoting Consistent Shoe Use Among Children At High Risk for Podoconiosis
|