Clinical trial NCT02839772: An RCT to Evaluate the Effect of a New Skin Care Regimen on SBF in Those With Podoconiosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-filarial Elephantiasis
Keywords: podoconiosis
glycerine
RCT
SBF
TEWL
SC hydration
Lead sponsor: University of Hull
Sponsor class: OTHER
Collaborators: name: Procter and Gamble
First posted: 2016-07-21
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An RCT (n=193) in two podoconiosis clinics in Ethiopia to evaluate the effectiveness of a research based skin management regimen compared to the current regimen. The experimental group added 2% glycerine to the current skin care regimen and used 1 litre of water in the water soak compared to the 6 litres used in the current regimen.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients in Ethiopia with a diagnosis of podoconiosis. That is those living above 1000 feet sea level with high rainfall, above 1,00mm annually with foot or lower leg oedema which had started in the feet, with sensation present in the feet and no hand involvement. The diagnosis was determined by the nurses at the outreach clinics.
* Patients who were able to understand instructions and give informed consent as determined by the nurses at the outreach clinics.
* Patients over 18 years of age.

Exclusion Criteria:

* Patients not diagnosed with podoconiosis as determined by nurses at the outreach clinics.
* Patients who were unable to understand instructions or give informed consent as determined by nurses at the outreach clinics.
* Patients under 18 years of age.

Primary outcomes:
measure: Change in TEWL at Top of Outer Lower Legs
timeFrame: Change from baseline following 3 months of intervention
measure: Change in TEWL at Mid-point Outer Lower Legs
timeFrame: Change from baseline following 3 months of intervention
measure: Change in TEWL at Base of Outer Lower Legs
timeFrame: Change from baseline following 3 months of intervention
measure: Change in TEWL at Top of Feet
timeFrame: Change from baseline following 3 months of intervention
measure: Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs
timeFrame: Change from baseline following 3 months of intervention
measure: Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg.
timeFrame: Change from baseline following 3 months of intervention
measure: Change in Stratum Corneum Hydration at Base of Outer Lower Leg
timeFrame: Change from baseline following 3 months of intervention
measure: Change in Stratum Corneum Hydration at Top of Feet
timeFrame: Change from baseline following 3 months of intervention
Secondary outcomes:
measure: Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit
timeFrame: Change from baseline following 3 months of intervention
measure: Total Number of Trophic Skin Changes (Mossy Changes) All Participants at Baseline and 4th Visit
timeFrame: Change from baseline following 3 months of intervention
measure: Total Number of All Participants With the Presence of a Bad Odour Emanating From Their Lower Limbs.
timeFrame: Change from baseline following 3 months of intervention
measure: Number of Wounds on Lower Legs/Feet of Participants.
timeFrame: Change from baseline following 3 months of intervention
measure: Change in Number of Work Days Lost in Previous Month Due to Adenolymphangitis (ADL)
timeFrame: Change from baseline following 3 months of intervention
measure: Correlation Between Number of Work Days Lost Due to Adenolymphangitis and Number of Wounds
timeFrame: From baseline monthly for 3 months
measure: Change in Largest Lower Leg Circumference
timeFrame: Change from baseline following 3 months of intervention
measure: Change in Largest Foot Circumference
timeFrame: Change from baseline following 3 months of intervention
measure: Amharic Dermatology Life Quality Index (DLQI)
timeFrame: Change from baseline following 3 months of intervention
Other outcomes:
Locations:
Study officials:
affiliation: University of Hull, UK
name: Jill Brooks, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leeds, UK
name: Steven J Ersser, PhD,
role: STUDY_DIRECTOR
affiliation: University of Hull, UK
name: Fiona C Cowdell, DProf,
role: STUDY_DIRECTOR
affiliation: University of Hull, UK
name: Eric Gardiner, PhD,
role: STUDY_DIRECTOR
affiliation: Procter and Gamble
name: Paul J Matts, PhD
role: STUDY_DIRECTOR
References: