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CompletedNCT04332796PK_treatmentUpdated May 25, 2023

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

A Phase 4 interventional study of Chorhexidine scrub and ZnO-NPs socks in Foot Dermatoses, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-25.

Sponsored by Mahidol University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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 treatment of pitted keratolysis.

Read the 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 treatment of pitted keratolysis.

Material and Methods Male security guards and hospital porters , who had pitted keratolysis were invited to enroll in this study. The security guards and hospital porters who previously received any topical treatment including topical antibiotic, antiperspirant or aluminum chloride within 2 weeks 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 and the combination of chlorhexidine scrub and ZnO-NPs socks for 4 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 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. Four 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 (a decrease of less than 50% in the number of pitted lesions) and much improvement (a decrease of 50% or above in the number of pitted lesions). Data were analyzed using SPSS version 18 (SPSS, Inc., Chicago, IL, USA).

Duration of study: 6 months Study design: Randomized control trial

02

Conditions studied

  • Foot Dermatoses

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Keywords

  • Pitted keratolysis
  • Foot Odor
  • Chlorhexidine solution
  • Zinc oxide nanoparticles
03

In context

Skin Diseases

538 studies on the registry are indexed under Skin Diseases; 92 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 372 interventional studies indexed under Skin Diseases.

Browse Skin Diseases studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male security guards and hospital porters , who had pitted keratolysis

Exclusion criteria

Exclusion Criteria:

  • Male security guards and hospital porters who previously received any topical treatment including topical antibiotic, antiperspirant or aluminum chloride within 2 weeks prior to the study.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Chorhexidine scrub

    Chorhexidine scrub was given to patients for 4 weeks

    Drug: Chorhexidine scrub

  • Active comparator
    ZnO-NPs socks

    ZnO-NPs socks to patients for 4 weeks

    Device: ZnO-NPs socks

  • Active comparator
    Combination of chorhexidine scrub and ZnO-NPs socks

    Chorhexidine scrub and ZnO-NPs socks to patients for 4 weeks

    Combination Product: Combination of chorhexidine scrub and ZnO-NPs socks

Interventions

  • DrugChorhexidine scrub

    Chorhexidine scrub was given to patients for 4 weeks

  • DeviceZnO-NPs socks

    ZnO-NPs socks was given to patients for 4 weeks

  • Combination productCombination of chorhexidine scrub and ZnO-NPs socks

    Combination of chorhexidine scrub and ZnO-NPs socks was given to patients for 4 weeks

06

What researchers measure

Primary outcomes

  1. The number of patients who had improvement of pitted lesion after treatment

    Effectiveness was evaluated

    Time frame: 4 weeks

Secondary outcomes

  1. The percentage of patients developed any side effect such as erythema, burning

    Side effects was assessed

    Time frame: 4 weeks

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Study locations

1 site
  • Department of Dermatology Siriraj Hospital
    Bangkok, 10700, Thailand
08

References and documents

Publications

  • 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. PubMed 26982791 ↗
  • 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. PubMed 28924971 ↗
  • 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. PubMed 22882561 ↗
  • 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. PubMed 30415588 ↗
  • 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. PubMed 19935134 ↗
  • 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. PubMed 29951993 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04332796
Lead sponsor
Mahidol University
Responsible party
Sponsor
First posted
Apr 3, 2020
Start date
Mar 15, 2022
Primary completion
Nov 1, 2022
Completion
Nov 1, 2022
Last update
May 25, 2023

Study contacts

Sumanas Bunyaratavej, MD
principal investigator · Mahidol University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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