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Removal of Dermal Exposure to Phthalate Ester by Hand Washing

Soap and the Removal of Diethylhexyl Phthalate From Hands: N-of-1 and Cross-Over Designs

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02707172
Enrollment
28
Registered
2016-03-14
Start date
2013-05-31
Completion date
2013-12-31
Last updated
2018-10-23

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

Conditions

Environmental Exposure, Exposure to Pollution

Keywords

Diethylhexyl Phthalate, Hand hygiene, Soaps, N-of-1 design, Cross-Over Studies

Brief summary

The aim of the study is to evaluate the effectiveness in removing chemical exposure on hand, the investigators compare removal efficiency of Di-(2-ethylhexyl)phthalate (DEHP) on hands by hand washing with soap and water vs. water only. In two three-day N-of-1 trials, residual DEHP was measured in a single female adult who washed exposed hands with soap-and-water or water-only. Subsequently, a crossover study was performed by randomly assigning another 28 subjects equally to wash with soap-and-water or with water-only, and then each one received the other treatment 24 hrs later.

Detailed description

Three studies, consisting of two N-of-1 trials and one crossover study, were used to compare the effect of handwashing with soap and water (intervention) and handwashing with water only (placebo) on phthalate removal from hands. The soap was plain soap, consisting of vegetable oil and sodium hydroxide. First, the investigators recruited one healthy female aged 25 yrs to participate in two N-of-1 trials. In each trial, her hands would be exposed to DEHP and then be treated with either soap intervention or placebo for three times over the course of three days. The first trial started on 15 May 2013. On day one, after the subject prewashed her hands, she allowed her hands to be exposed to a designated amount of DEHP. She then washed them with water only and rinsed them sequentially in three separate polyethylene (PE) bags, each containing 200 mL water to collect DEHP residue. One hour later, the same protocol was followed, except the exposed hands were treated with soap and water instead of water only (Figure 1a). The water rinsing in three separate bags remained the same. The pairs of studies were repeated on two subsequent days (16 and 17 May). In the second N-of-1 trial, which was also performed over three days (22-24 May), the protocol using the same subject remained the same for all three days, except that the subject underwent intervention first then placebo. The water rinsing remained the same. A randomized 2 × 2 crossover study was subsequently conducted between June and September 2013. The investigators assigned one group of 7 females and 7 males to perform handwashing with soap and water (intervention) and another group of 7 females and 7 males to perform handwashing with water only (placebo). Briefly, on the first day, the two groups washed their DEHP exposed hands using either soap and water or water only and then rinsed them in a PE bag with 200 mL water to collect DEHP. After 24 hrs, the experiment was crossed-over with the same two groups receiving the opposite treatments.

Interventions

BEHAVIORALhandwashing with soap

handwashing with soap by a standardized 6-step handwashing technique

BEHAVIORALhandwashing with water

handwashing with water by a standardized 6-step handwashing technique

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy adult over age of 18 years * BMI\>18

Exclusion criteria

* diagnosis of any type of cancers, dermatitis, asthma * cut, abrasion, and trauma on hands * BMI \<18

Design outcomes

Primary

MeasureTime frameDescription
Amount of Diethylhexyl Phthalate Removed From Handimmediately right after hand-washingWater rinse were performed immediately after hand-washing, and the concentration of diethylhexyl phthalate in the soiled water is measured.

Countries

Taiwan

Participant flow

Recruitment details

Participants were recruited from Kaohsiung Medical university in Kaohsiung City, Taiwan from May, 2013 to September, 2013.

Participants by arm

ArmCount
All Participants
A total of 28 participants were recruited and were divided into two groups, one group receiving placebo first and then intervention, the other group receiving intervention first and then placebo. The placebo is handwashing with water using the 6-step standardized handwashing technique. The intervention is handwasahing with soap using the 6-step standardized handwashing technique.
28
Total28

Baseline characteristics

CharacteristicAll Participants
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
28 Participants
Age, Continuous21.9 years
STANDARD_DEVIATION 1.6
Region of Enrollment
Taiwan
28 participants
Sex: Female, Male
Female
14 Participants
Sex: Female, Male
Male
14 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 280 / 28
other
Total, other adverse events
0 / 280 / 28
serious
Total, serious adverse events
0 / 280 / 28

Outcome results

Primary

Amount of Diethylhexyl Phthalate Removed From Hand

Water rinse were performed immediately after hand-washing, and the concentration of diethylhexyl phthalate in the soiled water is measured.

Time frame: immediately right after hand-washing

Population: Each participant underwent two sets of experiments, one with placebo and one with intervention. 14 participants received placebo first and were crossed-over to received intervention. The other 14 participants received intervention first and were crossed-over to received placebo.

ArmMeasureGroupValue (MEAN)Dispersion
All ParticipantsAmount of Diethylhexyl Phthalate Removed From HandIntervention94.64 percentage of DEHP removedStandard Deviation 6.49
All ParticipantsAmount of Diethylhexyl Phthalate Removed From HandPlacebo8.74 percentage of DEHP removedStandard Deviation 5.69

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026