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

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ClinicalTrials.gov Identifier: NCT04000386
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Brief Summary:
This study aimed to study the efficacy of zinc oxide nanoparticles coated socks in prevention of unpleasant foot odor

Condition or disease Intervention/treatment Phase
Zinc Oxide Foot Dermatoses Other: zinc oxide nanoparticles coated socks Other: placebo socks Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Single (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.
Primary Purpose: Prevention
Official Title: A Study of Efficacy of Zinc Oxide Nanoparticles Coated Socks in Prevention of Unpleasant Foot Odor
Actual Study Start Date : June 26, 2019
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: zinc oxide nanoparticles coated socks
62 patients with zinc oxide nanoparticles coated socks
Other: zinc oxide nanoparticles coated socks
zinc oxide nanoparticles coated socks were given to subjects for 2 weeks

Placebo Comparator: placebo
62 patients with placebo socks
Other: placebo socks
placebo socks were given to subjects for 2 weeks




Primary Outcome Measures :
  1. Effectiveness of zinc oxide nanoparticles coated socks in prevention of unpleasant foot odor [ Time Frame: 2 weeks ]
    Effectiveness was evaluated by the number of patients who had no or minimal foot odor after prevention


Secondary Outcome Measures :
  1. Effectiveness of zinc oxide nanoparticles coated socks in prevention of fungal feet infection [ Time Frame: 2 weeks ]
    Effectiveness was evaluated by the number of patients who had no fungal feet infection after prevention



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

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): NCT04000386


Contacts
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Contact: Charussri Leeyaphan, MD +664194333 charussrilee@gmail.com
Contact: Sumanas Bunyaratavej, MD +664194333 consultskin@yahoo.com

Locations
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Thailand
Department of Dermatology Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Contact: Sumanas Bunyaratavej, MD    : +664194333    consultskin@yahoo.com   
Contact: Charussri Leeyaphan,, MD    : +664194333    charussrilee@gmail.com   
Principal Investigator: Sumanas Bunyaratavej, MD         
Sub-Investigator: Charassri Leeyaphan, MD         
Sponsors and Collaborators
Mahidol University

Publications of Results:

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT04000386     History of Changes
Other Study ID Numbers: zincoxide_PK
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mahidol University:
Pitted keratolysis
zinc oxide
Foot Odor
preventsion

Additional relevant MeSH terms:
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Skin Diseases
Foot Dermatoses
Foot Diseases
Zinc
Zinc Oxide
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Dermatologic Agents
Sunscreening Agents
Radiation-Protective Agents
Protective Agents