Removal of Dermal Exposure to Phthalate Ester by Hand Washing

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02707172
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Environmental Exposure; Exposure to Pollution	Behavioral: handwashing with soap; Behavioral: handwashing with water	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Soap and the Removal of Diethylhexyl Phthalate From Hands: N-of-1 and Cross-Over Designs
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Subject was first exposed to 1000 microgram of diethylhexyl phthalate on both hands, and was asked to perform the intervention, handwashing with soap, by a standardized hand washing technique. Then the subjects in this arms are crossover to receive placebo, handwashing with water only.	Behavioral: handwashing with soap; handwashing with soap by a standardized 6-step handwashing technique; Behavioral: handwashing with water; handwashing with water by a standardized 6-step handwashing technique
Placebo Comparator: Placebo Subject was exposed to 1000 microgram of diethylhexyl phthalate on both hands, and was asked to perform the placebo, handwashing with water, by a standardized hand washing technique. Then the subjects in this arms are crossover to perform the intervention, handwashing with soap.	Behavioral: handwashing with soap; handwashing with soap by a standardized 6-step handwashing technique; Behavioral: handwashing with water; handwashing with water by a standardized 6-step handwashing technique

Outcome Measures

Primary Outcome Measures

1. Amount of Diethylhexyl Phthalate Removed From Hand [immediately right after hand-washing]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Medical University	Kaohsiung	Kaohsiung County	Taiwan	807

Sponsors and Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

• Principal Investigator: Ming-Tsang Wu, ScD, Kaohsiung Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ming-Tsang Wu, Director of Center of Environmental & Occupational Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital
• ClinicalTrials.gov Identifier: NCT02707172
• Other Study ID Numbers: KMU-PH-201301
• First Posted: Mar 14, 2016
• Last Update Posted: Oct 23, 2018
• Last Verified: Sep 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Ming-Tsang Wu, Director of Center of Environmental & Occupational Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital: Diethylhexyl Phthalate; Hand hygiene; Soaps; N-of-1 design; Cross-Over Studies

Study Results

Participant Flow

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

Arm/Group Title	All Participants
Arm/Group Description	All participants underwent two experiments, one with placebo (handwashing with water) and one with intervention (handwashing with soap), but in different order. 28 participants underwent placebo first and crossed-over to received intervention; while the other 28 participants underwent intervention first and then placebo. There was one day wash-out period between the two sets of experiment. In each set of the experiment, each participant was exposed to 1000 microgram of diethylhexyl phthalate on both hands, and was asked to perform the placebo or intervention by a standardized hand washing technique depending on the sequence assignment. A total of 56 placebo experiments were performed and a total of 56 intervention experiments were performed in the study.
Period Title: 1st Set of Experiment
STARTED	28
COMPLETED	28
NOT COMPLETED	0
Period Title: 1st Set of Experiment
STARTED	28
COMPLETED	28
NOT COMPLETED	0
Period Title: 1st Set of Experiment
STARTED	28
COMPLETED	28
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	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.
Overall Participants	28
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	28 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	21.9 (1.6)
Sex: Female, Male (Count of Participants)
Female	14 50%
Male	14 50%
Region of Enrollment (participants) [Number]
Taiwan	28 100%

Outcome Measures

1. Primary Outcome

Title	Amount of Diethylhexyl Phthalate Removed From Hand
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	All Participants
Arm/Group Description	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.
Measure Participants	28
Intervention	94.64 (6.49)
Placebo	8.74 (5.69)

Adverse Events

Time Frame	1 year
Arm/Group Title	Intervention		Placebo
Arm/Group Description	Subject was first exposed to 1000 microgram of diethylhexyl phthalate on both hands, and was asked to perform the intervention, handwashing with soap, by a standardized hand washing technique. Then the subjects in this arms are crossover to receive placebo, handwashing with water only. handwashing with soap: handwashing with soap by a standardized 6-step handwashing technique handwashing with water: handwashing with water by a standardized 6-step handwashing technique		Subject was exposed to 1000 microgram of diethylhexyl phthalate on both hands, and was asked to perform the placebo, handwashing with water, by a standardized hand washing technique. Then the subjects in this arms are crossover to perform the intervention, handwashing with soap. handwashing with soap: handwashing with soap by a standardized 6-step handwashing technique handwashing with water: handwashing with water by a standardized 6-step handwashing technique
All Cause Mortality
	Intervention		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/28 (0%)
Serious Adverse Events
	Intervention		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	Intervention		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/28 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.