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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02839772
• Other study ID #: UHull
• Status: Completed
• Phase: Phase 3
• First received: July 12, 2016
• Last updated: July 20, 2016
• Start date: January 2014
• Est. completion date: August 2014

Study information

• Verified date: July 2016
• Source: University of Hull
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

An RCT in two podoconiosis clinics in Ethiopia to evaluate the effectiveness of the addition of 2% glycerine to the current skin care regimen

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Filariasis
• Non-filarial Elephantiasis

Intervention

Other:
• Current skin care regimen plus 2% glycerine

• Current skin care regimen

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Hull	Procter and Gamble

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin barrier function	Trans-epidermal water loss and stratum corneum hydration measured with non-invasive probes at specific points on the outer lower leg and on the top of the foot	change from baseline monthly for 3 months	No
Secondary	Stage of podoconiosis	Staging System	change from baseline monthly for 3 months	No
Secondary	Trophic (mossy changes)	observation	change from baseline monthly for 3 months	No
Secondary	Odour from lower limbs	bad smell	change from baseline monthly for 3 months	No
Secondary	Number of wounds on lower limbs	observation	change from baseline monthly for 3 months	No
Secondary	Number of work days lost in previous month due to adenolymphangitis	questionnaire	change from baseline monthly for 3 months	No
Secondary	Correlation between days lost due to adenolymphangitis and number of wounds	statistical calculation	change from baseline monthly for 3 months	No
Secondary	Largest lower leg circumference	measured in centimetres	change from baseline monthly for 3 months	No
Secondary	Largest foot circumference	measured in centimetres	change from baseline monthly for 3 months	No
Secondary	Amharic Dermatology Life Quality Index (DLQI)	questionnaire	change from baseline monthly for 3 months	No