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A Study of Efficacy of Zinc Oxide Nanoparticles Coated Socks in Prevention of Unpleasant Foot Odor

Primary Purpose

Zinc Oxide, Foot Dermatoses

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
zinc oxide nanoparticles coated socks
placebo socks
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Zinc Oxide focused on measuring Pitted keratolysis, zinc oxide, Foot Odor, preventsion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • First-year naval rating cadets, who had no pedal malodor

Exclusion Criteria:

  • The cadets who previously received any topical treatment including topical antibiotic, antiperspirant or aluminum chloride within 6 months prior to the study.

Sites / Locations

  • Department of Dermatology Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

zinc oxide nanoparticles coated socks

placebo

Arm Description

62 patients with zinc oxide nanoparticles coated socks

62 patients with placebo socks

Outcomes

Primary Outcome Measures

Effectiveness of zinc oxide nanoparticles coated socks in prevention of unpleasant foot odor
Effectiveness was evaluated by the number of patients who had no or minimal foot odor after prevention

Secondary Outcome Measures

Effectiveness of zinc oxide nanoparticles coated socks in prevention of fungal feet infection
Effectiveness was evaluated by the number of patients who had no fungal feet infection after prevention

Full Information

First Posted
June 26, 2019
Last Updated
February 25, 2021
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT04000386
Brief Title
A Study of Efficacy of Zinc Oxide Nanoparticles Coated Socks in Prevention of Unpleasant Foot Odor
Official Title
A Study of Efficacy of Zinc Oxide Nanoparticles Coated Socks in Prevention of Unpleasant Foot Odor
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 26, 2019 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
February 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aimed to study the efficacy of zinc oxide nanoparticles coated socks in prevention of unpleasant foot odor
Detailed Description
Introduction Pitted keratolysis is a common skin disease, caused by various gram-positive bacteria including Corynebacterium species, Kytococcus sedentarius, Dermatophilus congolensis and Actinomyces species. These bacteria create small tunnels in the stratum corneum, causing pitted lesions at plantar areas. This condition is frequent accompanied by feet malodor and is commonly found in young male adults, especially in soldiers, miners and athletes. The reported prevalence of pitted keratolysis among naval cadets in Thailand was 38.7%. Predisposing factors related to pitted keratolysis are pedal hyperhidrosis and prolonged feet occlusion. Although this condition is generally not painful, our previous study in 2018 revealed adversely affects patients' quality of life. Regarding treatment modalities of pitted keratolysis, various medications and life-style modification have been recommended. Previous studies revealed efficacy of topical choices, including benzoyl peroxide gel, clindamycin-benzoyl peroxide gel, glycopyrrolate cream, erythromycin gel, clindamycin solution, chlorhexidine scrub4 and mupirocin ointment. Oral antibiotics and botulinum toxin injection were also beneficial in pitted keratolysis. As to life-style modification, wearing cotton socks and opened footwear, and proper hygiene, have also been suggested. Previous studies demonstrated efficacy of zinc oxide in broad-spectrum antibacterial properties. Thus, zinc oxide has been used in various medical and apparel industrial products. Moreover, Commander Choopong Chailark invented socks coated with zinc oxide nanoparticles and reported antibacterial property of those socks. Objective The present study aimed to study the efficacy of zinc oxide nanoparticles coated socks in prevention of unpleasant foot odor Material and Methods First-year naval rating cadets, who had no pedal malodor were invited to enroll in this study. Consent was informed and obtained from all participants. Participants were assessed for behavioral risk factors and level of foot odor measured by a self-assessed visual analogue scale (VAS), using questionnaires. Subjects were randomly assigned either zinc oxide nanoparticles coated socks or ordinary socks.During the study, using of other topical treatment such as topical antibiotics, antiperspirant or aluminum chloride was not allowed. Participants were advised to wear those socks every day and regularly washed thier socks. All were able to regularly participate in physical military training during the study. Two weeks after the study clinical examinations by dermatologists and the cadets' self-assessment questionnaires, including feet odor by using VAS, treatment satisfaction and adverse effects, were used to evaluate the effectiveness. Pitted lesions improvement at plantar areas, evaluated by dermatologists, was divided into no improvement, slight improvement (decrease of pitted lesions at feet for 1 level) and much improvement (decrease of pitted lesions at feet for at least 2 level). Data were analyzed using Predictive Analytics SoftWare Statistics version 18 (SPSS, Inc., Chicago, Illinois, USA). Duration of study: 4 months Study design: Randomized control trial

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zinc Oxide, Foot Dermatoses
Keywords
Pitted keratolysis, zinc oxide, Foot Odor, preventsion

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Participant
Masking Description
Single (Participant) Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Single blind controlled trial between participants, drug preparing team, doctors, investigators, and outcome assessors.
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
zinc oxide nanoparticles coated socks
Arm Type
Experimental
Arm Description
62 patients with zinc oxide nanoparticles coated socks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
62 patients with placebo socks
Intervention Type
Other
Intervention Name(s)
zinc oxide nanoparticles coated socks
Intervention Description
zinc oxide nanoparticles coated socks were given to subjects for 2 weeks
Intervention Type
Other
Intervention Name(s)
placebo socks
Intervention Description
placebo socks were given to subjects for 2 weeks
Primary Outcome Measure Information:
Title
Effectiveness of zinc oxide nanoparticles coated socks in prevention of unpleasant foot odor
Description
Effectiveness was evaluated by the number of patients who had no or minimal foot odor after prevention
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Effectiveness of zinc oxide nanoparticles coated socks in prevention of fungal feet infection
Description
Effectiveness was evaluated by the number of patients who had no fungal feet infection after prevention
Time Frame
2 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: First-year naval rating cadets, who had no pedal malodor Exclusion Criteria: The cadets who previously received any topical treatment including topical antibiotic, antiperspirant or aluminum chloride within 6 months prior to the study.
Facility Information:
Facility Name
Department of Dermatology Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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26982791
Citation
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A Study of Efficacy of Zinc Oxide Nanoparticles Coated Socks in Prevention of Unpleasant Foot Odor

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