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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04332796
Other study ID # PK_treatment
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 15, 2022
Est. completion date November 1, 2022

Study information

Verified date May 2023
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 1, 2022
Est. primary completion date November 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male security guards and hospital porters , who had pitted keratolysis 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Chorhexidine scrub
Chorhexidine scrub was given to patients for 4 weeks
Device:
ZnO-NPs socks
ZnO-NPs socks was given to patients for 4 weeks
Combination Product:
Combination of chorhexidine scrub and ZnO-NPs socks
Combination of chorhexidine scrub and ZnO-NPs socks was given to patients for 4 weeks

Locations

Country Name City State
Thailand Department of Dermatology Siriraj Hospital Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (6)

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 — View 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. — View 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 p — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The number of patients who had improvement of pitted lesion after treatment Effectiveness was evaluated 4 weeks
Secondary The percentage of patients developed any side effect such as erythema, burning Side effects was assessed 4 weeks
See also
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Withdrawn NCT04337749 - Chlorhexidine Scrub, ZnO Nanoparticles Socks and the Combination for Prevention of Pitted Keratolysis Phase 4
Recruiting NCT04336514 - A Longitudinal Quantitative Assessment of the Effectiveness of Metatarsal Pads on Plantar Pressures N/A
Completed NCT04000386 - A Study of Efficacy of Zinc Oxide Nanoparticles Coated Socks in Prevention of Unpleasant Foot Odor N/A
Withdrawn NCT04000347 - A Study of Efficacy of Benzoyl Peroxide Regimens in Treatment of Unpleasant Foot Odor Phase 4
Completed NCT02705664 - Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus a Two-course Treatment With Urea 40% Ointment and Bifonazole Cream 1% Phase 4
Completed NCT02321098 - Antifungal Activity of Loceryl Nail Lacquer in Combination With a Cosmetic Varnish Phase 4