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Removal of Dermal Exposure to Phthalate Ester by Hand Washing

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ClinicalTrials.gov Identifier: NCT02707172
Recruitment Status : Completed
First Posted : March 14, 2016
Results First Posted : April 14, 2017
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Ming-Tsang Wu, Kaohsiung Medical University Chung-Ho Memorial Hospital

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

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




Primary Outcome Measures :
  1. Amount of Diethylhexyl Phthalate Removed From Hand [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02707172


Locations
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Taiwan
Kaohsiung Medical University
Kaohsiung, Kaohsiung County, Taiwan, 807
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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Principal Investigator: Ming-Tsang Wu, ScD Kaohsiung Medical University
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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: March 14, 2016    Key Record Dates
Results First Posted: April 14, 2017
Last Update Posted: October 23, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ming-Tsang Wu, Kaohsiung Medical University Chung-Ho Memorial Hospital:
Diethylhexyl Phthalate
Hand hygiene
Soaps
N-of-1 design
Cross-Over Studies