An RCT to Evaluate the Effect of a New Skin Care Regimen on SBF in Those With Podoconiosis

NCT ID: NCT02839772

Last Updated: 2017-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 193 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-08-31

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.

Conditions

Non-filarial Elephantiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Current skin care regimen

Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (0.0125%), air dried, thin layer of petrolatum jelly applied and Whitfields ointment if required for any fungal infection.

Group Type: ACTIVE_COMPARATOR

Current skin care regimen

Intervention Type: OTHER

Current skin regimen plus 2% glycerine

Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied and Whitfields ointment if required for any fungal infection.

Group Type: EXPERIMENTAL

Current skin care regimen plus 2% glycerine added to soaking water

Intervention Type: OTHER

Interventions

Current skin care regimen plus 2% glycerine added to soaking water

Intervention Type: OTHER

Current skin care regimen

Intervention Type: OTHER

Other Intervention Names

glycerine

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: collaborator

University of Hull

OTHER

Sponsor Role: lead

Responsible Party

Jill Brooks

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jill Brooks, PhD student

Role: PRINCIPAL_INVESTIGATOR

University of Hull, UK

Steven J Ersser, PhD,

Role: STUDY_DIRECTOR

University of Leeds, UK

Fiona C Cowdell, DProf,

Role: STUDY_DIRECTOR

University of Hull, UK

Eric Gardiner, PhD,

Role: STUDY_DIRECTOR

University of Hull, UK

Paul J Matts, PhD

Role: STUDY_DIRECTOR

Procter and Gamble

Other Identifiers

UHull

Identifier Type: -

Identifier Source: org_study_id