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Chlorhexidine Scrub, ZnO Nanoparticles Socks and the Combination for Prevention of Pitted Keratolysis (PKprevention)

Primary Purpose

Foot Dermatoses

Status
Not yet recruiting
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Chorhexidine scrub
ZnO-NPs socks
Combination of chorhexidine scrub and ZnO-NPs socks
Placebo socks
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Foot Dermatoses focused on measuring Pitted keratolysis, Prevention, Chlorhexidine solution, Zinc oxide nanoparticles

Eligibility Criteria

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

Inclusion Criteria:

  • First-year naval rating cadets, who did not have pitted keratolysis

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 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Chorhexidine scrub

ZnO-NPs socks

Combination of chorhexidine scrub and ZnO-NPs socks

Placebo

Arm Description

Chorhexidine scrub was given to participants for 2 weeks

ZnO-NPs socks were given to participants for 2 weeks

Chorhexidine scrub and ZnO-NPs socks were given to participants for 2 weeks

Placebo socks were given to participants for 2 weeks

Outcomes

Primary Outcome Measures

The number of patients who had pitted keratolysis after treatment
Effectiveness was evaluated

Secondary Outcome Measures

The percentage of patients developed any side effect such as erythema, burning
Side effects were assessed

Full Information

First Posted
April 5, 2020
Last Updated
September 11, 2022
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT04337749
Brief Title
Chlorhexidine Scrub, ZnO Nanoparticles Socks and the Combination for Prevention of Pitted Keratolysis
Acronym
PKprevention
Official Title
A Study of Efficacy of Chlorhexidine Scrub, ZnO Nanoparticles Socks and the Combination of Chlorhexidine Scrub and ZnO Nanoparticles Socks for Prevention of Pitted Keratolysis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 5, 2022 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

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 chlorhexidine scrub, zinc oxide nanoparticles (ZnO-NPs) socks and the combination of chlorhexidine scrub and ZnO-NPs socks in prevention of pitted keratolysis.
Detailed Description
Introduction Pitted keratolysis is a common skin disease, caused by various gram-positive bacteria including Corynebacterium species, Kytococcus sedentarius, Dermophilus 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 scrub 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. Zinc oxide (ZnO) has been demonstrated to exhibit antimicrobial activities against many microorganisms, such as Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa and fungal infections including dermatophytosis. It has been proposed that the mechanism is the generation of reactive oxygen species, such as hydrogen peroxide, on microorganism cell surfaces, thereby causing membrane dysfunction. The antimicrobial activities have been observed to vary with changes in the physical and chemical properties of ZnO, for instance, its particle size, porosity and specific surface area. Nanobiotechnology , which is the integration of biotechnology and nanotechnology, is currently being used in drug delivery systems. The bactericidal efficacy of ZnO nanoparticles (ZnO-NPs) has been shown to improves with a decrease in their particle size. ZnO has also been shown to be is safe and compatible with human skin, which makes it a suitable additive for textiles. Research by Choopong and Sarayut established that ZnO-NP-coated socks exhibited antimicrobial activities against gram-positive (S. aureus) and gram-negative (Klebsiella pneumoniae) bacteria. Objective This study aimed to study the efficacy of chlorhexidine scrub, zinc oxide nanoparticles (ZnO-NPs) socks and the combination of chlorhexidine scrub and ZnO-NPs socks in prevention of pitted keratolysis. Material and Methods First-year naval rating cadets, who did not have pitted keratolysis were invited to enroll in this study. The cadets who previously received any topical treatment including topical antibiotic, antiperspirant or aluminum chloride within 6 months prior to the study were excluded. 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. Clinically examination of feet was done in all subjects by treatment-blinded dermatologists. Subjects were randomly assigned either chlorhexidine scrub, ZnO-NPs socks, the combination of chlorhexidine scrub and ZnO-NPs socks, or placebo socks for 2 weeks. During the study, using of other topical treatment such as topical antibiotics, antiperspirant or aluminum chloride was not allowed. Participants who received chlorhexidine scrub were advised to wash their both soles with chlorhexidine scrub two times per day in the morning and evening. Participants who received ZnO-NPs socks or placeblo socks were asked to wear these socks everyday and at least 8 hours per day. All were able to regularly participate in physical military training during the study. Two weeks after the treatment, 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 SPSS version 18 (SPSS, Inc., Chicago, IL, USA). Duration of study: 6 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
Foot Dermatoses
Keywords
Pitted keratolysis, Prevention, Chlorhexidine solution, Zinc oxide nanoparticles

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Single blind controlled trial between participants, drug preparing team, doctors, investigators, and outcome assessors.
Allocation
Randomized
Enrollment
316 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chorhexidine scrub
Arm Type
Active Comparator
Arm Description
Chorhexidine scrub was given to participants for 2 weeks
Arm Title
ZnO-NPs socks
Arm Type
Active Comparator
Arm Description
ZnO-NPs socks were given to participants for 2 weeks
Arm Title
Combination of chorhexidine scrub and ZnO-NPs socks
Arm Type
Active Comparator
Arm Description
Chorhexidine scrub and ZnO-NPs socks were given to participants for 2 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo socks were given to participants for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Chorhexidine scrub
Intervention Description
Chorhexidine scrub was given to patients for 2 weeks
Intervention Type
Device
Intervention Name(s)
ZnO-NPs socks
Intervention Description
ZnO-NPs socks were given to patients for 2 weeks
Intervention Type
Combination Product
Intervention Name(s)
Combination of chorhexidine scrub and ZnO-NPs socks
Intervention Description
Combination of chorhexidine scrub and ZnO-NPs socks were given to patients for 2 weeks
Intervention Type
Device
Intervention Name(s)
Placebo socks
Intervention Description
Placebo socks were given to patients for 2 weeks
Primary Outcome Measure Information:
Title
The number of patients who had pitted keratolysis after treatment
Description
Effectiveness was evaluated
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
The percentage of patients developed any side effect such as erythema, burning
Description
Side effects were assessed
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 did not have pitted keratolysis Exclusion Criteria: The cadets who previously received any topical treatment including topical antibiotic, antiperspirant or aluminum chloride within 6 months prior to the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charussri Leeyaphan, MD
Phone
+6624194333
Email
charussrilee@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sumanas Bunyaratavej, MD
Phone
+6624194333
Email
consultskin@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charussri Leeyaphan, MD
Organizational Affiliation
Department of Dermatology Faculty of Medicine, Siriraj Hospital Mahidol Universit
Official's Role
Principal Investigator
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
No
IPD Sharing Plan Description
There is not a plan to make IPD available.
Citations:
PubMed Identifier
26982791
Citation
de Almeida HL Jr, Siqueira RN, Meireles Rda S, Rampon G, de Castro LA, Silva RM. Pitted keratolysis. An Bras Dermatol. 2016 Jan-Feb;91(1):106-8. doi: 10.1590/abd1806-4841.20164096.
Results Reference
result
PubMed Identifier
28924971
Citation
Makhecha M, Dass S, Singh T, Gandhi R, Yadav T, Rathod D. Pitted keratolysis - a study of various clinical manifestations. Int J Dermatol. 2017 Nov;56(11):1154-1160. doi: 10.1111/ijd.13744. Epub 2017 Sep 18.
Results Reference
result
PubMed Identifier
22882561
Citation
van der Snoek EM, Ekkelenkamp MB, Suykerbuyk JC. Pitted keratolysis; physicians' treatment and their perceptions in Dutch army personnel. J Eur Acad Dermatol Venereol. 2013 Sep;27(9):1120-6. doi: 10.1111/j.1468-3083.2012.04674.x. Epub 2012 Aug 7.
Results Reference
result
PubMed Identifier
30415588
Citation
Leeyaphan C, Bunyaratavej S, Taychakhoonavudh S, Kulthanachairojana N, Pattanaprichakul P, Chanyachailert P, Ongsri P, Arunkajohnsak S, Limphoka P, Kulthanan K. Cost-effectiveness analysis and safety of erythromycin 4% gel and 4% chlorhexidine scrub for pitted keratolysis treatment. J Dermatolog Treat. 2019 Sep;30(6):627-629. doi: 10.1080/09546634.2018.1543846. Epub 2018 Dec 11.
Results Reference
result
PubMed Identifier
19935134
Citation
Vlahovic TC, Dunn SP, Kemp K. The use of a clindamycin 1%-benzoyl peroxide 5% topical gel in the treatment of pitted keratolysis: a novel therapy. Adv Skin Wound Care. 2009 Dec;22(12):564-6. doi: 10.1097/01.ASW.0000363468.18117.fe. No abstract available.
Results Reference
result
PubMed Identifier
29951993
Citation
Bunyaratavej S, Leeyaphan C, Chanyachailert P, Pattanaprichakul P, Ongsri P, Kulthanan K. Clinical manifestations, risk factors and quality of life in patients with pitted keratolysis: a cross-sectional study in cadets. Br J Dermatol. 2018 Nov;179(5):1220-1221. doi: 10.1111/bjd.16923. Epub 2018 Sep 14. No abstract available.
Results Reference
result

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Chlorhexidine Scrub, ZnO Nanoparticles Socks and the Combination for Prevention of Pitted Keratolysis

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