NCT02707172

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 14, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 14, 2017

Completed
Last Updated

October 23, 2018

Status Verified

September 1, 2018

Enrollment Period

5 months

First QC Date

March 3, 2016

Results QC Date

April 6, 2016

Last Update Submit

September 23, 2018

Conditions

Environmental ExposureExposure to Pollution

Keywords

Diethylhexyl PhthalateHand hygieneSoapsN-of-1 designCross-Over Studies

Outcome Measures

Primary Outcomes (1)

  • 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.

    immediately right after hand-washing

Study Arms (2)

Intervention

EXPERIMENTAL

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 soapBehavioral: handwashing with water

Placebo

PLACEBO COMPARATOR

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 soapBehavioral: handwashing with water

Interventions

handwashing with soapBEHAVIORAL

handwashing with soap by a standardized 6-step handwashing technique

InterventionPlacebo
handwashing with waterBEHAVIORAL

handwashing with water by a standardized 6-step handwashing technique

InterventionPlacebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, Kaohsiung County, 807, Taiwan

Location

MeSH Terms

Interventions

Hand DisinfectionSoapsWater

Intervention Hierarchy (Ancestors)

Hand HygieneHygienePublic HealthEnvironment and Public HealthDetergentsSurface-Active AgentsSpecialty Uses of ChemicalsChemical Actions and UsesHousehold ProductsTechnology, Industry, and AgricultureHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Results Point of Contact

Title
Dr. Ming-Tsang Wu
Organization
Kaohsiung Medical University
e_encourage@yahoo.com
+886-7-3121101

Study Officials

  • Ming-Tsang Wu, ScD

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Center of Environmental & Occupational Medicine

Study Record Dates

First Submitted

March 3, 2016

First Posted

March 14, 2016

Study Start

May 1, 2013

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

October 23, 2018

Results First Posted

April 14, 2017

Record last verified: 2018-09

Locations

TW(1)