Seeking clearer recommendations for hand hygiene in communities facing Ebola: a randomized trial investigating the impact of six handwashing methods on skin irritation and dermatitis

Comparison of soap, hand sanitizer, and 0.05% NaDCC, HTH, and NaOCl chlorine solutions in the development of dermatitis among healthy volunteers during frequent handwashing

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN89815514

Enrollment

108

Registered

2016-01-27

Start date

2015-09-11

Completion date

Unknown

Last updated

2023-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritant contact dermatitis is a condition of skin inflammation and skin barrier disruption that can cause transepidermal water loss, itching, redness, swelling, and an increase in disease transmission risk when irritating substances cause dehydration of the stratum corneum. Skin and Connective Tissue Diseases Irritant contact dermatitis

Interventions

Subjects are randomly allocated to one of six arms. They are asked to wash their hands ten times per day with the handwashing method assigned to them. The handwashing methods are: 1. w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Potential participants must be: 1. healthy volunteers 2. either gender 3. aged between 18-65 4. English-speaking

Exclusion criteria

Exclusion criteria: Potential participants must not: 1. have a history of dermatitis 2. be pregnant or trying to become pregnant 3. patch test positive for any study substance 4. have baseline skin abnormalities or open sores/cuts 5. work in a profession where hands are frequently wet or exposed to irritants 6. have mental health issues that may be triggered by a study related to hand hygiene

Design outcomes

Primary

Measure	Time frame
1. Hand Eczema Index Score (HECSI). The HECSI score is a measurement of skin irritation on hands composed of individual scores detailing the severity of nine different signs of irritation (itchiness, pain, redness, flaking, cracks in the skin, skin thickening, swelling, bumps, and blisters) on each part of the hands assigned by a trained researcher. A board-certified dermatologist will examine each subject to determine diagnosis of clinical dermatitis. HECSI score is measured at baseline and on each day of the 28 days of handwashing. 2. Clinical diagnosis of dermatitis. Dermatitis diagnosis takes place at endline, at the end of day 28 of handwashing.	—

Measure

Time frame

1. Hand Eczema Index Score (HECSI). The HECSI score is a measurement of skin irritation on hands composed of individual scores detailing the severity of nine different signs of irritation (itchiness, pain, redness, flaking, cracks in the skin, skin thickening, swelling, bumps, and blisters) on each part of the hands assigned by a trained researcher. A board-certified dermatologist will examine each subject to determine diagnosis of clinical dermatitis. HECSI score is measured at baseline and on each day of the 28 days of handwashing. 2. Clinical diagnosis of dermatitis. Dermatitis diagnosis takes place at endline, at the end of day 28 of handwashing.

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Secondary

Measure	Time frame
1. Allergy patch testing. Patch testing is conducted to determine whether subjects have an allergy to any substance that might be a confounding factor if the subject develops irritation or dermatitis and is done by placing a patch with small discs containing each substance used for handwashing on the upper back from 48hrs. Researchers then view the area for signs of allergy at 48hr, 96hrs, and 7 days. 2. Self-rated hand score. For the self-rated hand score subjects used a scale from 0-10 to self-rate the level of discomfort that they were currently experiencing on their hands along with nine different symptoms, including itchiness, pain, redness, flaking, cracks in the skin, skin thickening, swelling, bumps, and blisters.	—

Measure

Time frame

1. Allergy patch testing. Patch testing is conducted to determine whether subjects have an allergy to any substance that might be a confounding factor if the subject develops irritation or dermatitis and is done by placing a patch with small discs containing each substance used for handwashing on the upper back from 48hrs. Researchers then view the area for signs of allergy at 48hr, 96hrs, and 7 days. 2. Self-rated hand score. For the self-rated hand score subjects used a scale from 0-10 to self-rate the level of discomfort that they were currently experiencing on their hands along with nine different symptoms, including itchiness, pain, redness, flaking, cracks in the skin, skin thickening, swelling, bumps, and blisters.

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Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 28, 2026