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

NCT02839772 | Completed Phase 3 Results

• 1 other identifier: UHull
• Study Type: interventional
• Target: 193
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-filarial Elephantiasis

Keywords

podoconiosis; glycerine; RCT; SBF; TEWL; SC hydration

Outcome Measures

Primary Outcomes (8)

• Change in TEWL at Top of Outer Lower Legs

  Trans-epidermal water loss (TEWL) was measured with a Vapometer (non-invasive probe) on the outer lower leg 8 cms below the head of the fibula. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.

  Change from baseline following 3 months of intervention

• Change in TEWL at Mid-point Outer Lower Legs

  Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the outer lower leg. This was mid-way between the measurement site at the top of the outer leg and the site at the base of the outer lower leg. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.

  Change from baseline following 3 months of intervention

• Change in TEWL at Base of Outer Lower Legs

  Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the outer lower leg 8cms above the external malleolus. A reduction in TEWL indicates a positive effect on skin barrier function.It is generally recommended that differences or percentage changes are reported rather than absolute values. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.

  Change from baseline following 3 months of intervention

• Change in TEWL at Top of Feet

  Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the top of the foot. A reduction in TEWL indicates a positive effect on skin barrier function.It is generally recommended that differences or percentage changes are reported rather than absolute values. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.

  Change from baseline following 3 months of intervention

• Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs

  Stratum corneum hydration was measured at a specific point at top of outer lower leg (8cms below the head of the fibula) with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.

  Change from baseline following 3 months of intervention

• Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg.

  SCH was measured mid-way between the measurement site at the top of the outer leg and the site at the base of the outer lower leg. It was measured with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.

  Change from baseline following 3 months of intervention

• Change in Stratum Corneum Hydration at Base of Outer Lower Leg

  Stratum corneum hydration was measured at the base of the outer lower leg 8 cms above the external malleolus. It was measured with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.

  Change from baseline following 3 months of intervention

• Change in Stratum Corneum Hydration at Top of Feet

  Stratum corneum hydration measured at a specific point on the middle top of the foot with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.

  Change from baseline following 3 months of intervention

Secondary Outcomes (9)

• Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit

  Change from baseline following 3 months of intervention

• Total Number of Trophic Skin Changes (Mossy Changes) All Participants at Baseline and 4th Visit

  Change from baseline following 3 months of intervention

• Total Number of All Participants With the Presence of a Bad Odour Emanating From Their Lower Limbs.

  Change from baseline following 3 months of intervention

• Number of Wounds on Lower Legs/Feet of Participants.

  Change from baseline following 3 months of intervention

• Change in Number of Work Days Lost in Previous Month Due to Adenolymphangitis (ADL)

  Change from baseline following 3 months of intervention

Study Arms (2)

Current skin care regimen

ACTIVE COMPARATOR

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.

Other: Current skin care regimen

Current skin regimen plus 2% glycerine

EXPERIMENTAL

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.

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

Interventions

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

Also known as: glycerine

Current skin regimen plus 2% glycerine

Current skin care regimen OTHER

Current skin care regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Hull: lead
• Procter and Gamble: collaborator

MeSH Terms

Conditions

Elephantiasis

Interventions

Glycerol

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Triose Sugar Alcohols; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Limitations and Caveats

The study was not blinded which would have strengthened credibility and limited bias.The groups were matched but factors such as diet and co-morbidities particularly relating to blood flow in the legs/feet were not collected.

Results Point of Contact

• Title: Jill Brooks. PhD student,
• Organization: University of Hull

jb284@btinternet.com

01491 839044

Study Officials

• Jill Brooks, PhD student

  University of Hull, UK

  PRINCIPAL INVESTIGATOR

• Steven J Ersser, PhD,

  University of Leeds, UK

  STUDY DIRECTOR

• Fiona C Cowdell, DProf,

  University of Hull, UK

  STUDY DIRECTOR

• Eric Gardiner, PhD,

  University of Hull, UK

  STUDY DIRECTOR

• Paul J Matts, PhD

  Procter and Gamble

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 21, 2016
• Study Start: January 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 6, 2017
• Results First Posted: January 6, 2017

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share