A Study of Efficacy of Zinc Oxide Nanoparticles Coated Socks in Prevention of Unpleasant Foot Odor
NCT ID: NCT04000386
Last Updated: 2021-03-01
Study Results
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Basic Information
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COMPLETED
NA
124 participants
INTERVENTIONAL
2019-06-26
2021-02-25
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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zinc oxide nanoparticles coated socks
62 patients with zinc oxide nanoparticles coated socks
zinc oxide nanoparticles coated socks
zinc oxide nanoparticles coated socks were given to subjects for 2 weeks
placebo
62 patients with placebo socks
placebo socks
placebo socks were given to subjects for 2 weeks
Interventions
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zinc oxide nanoparticles coated socks
zinc oxide nanoparticles coated socks were given to subjects for 2 weeks
placebo socks
placebo socks were given to subjects for 2 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
MALE
Yes
Sponsors
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Mahidol University
OTHER
Responsible Party
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Locations
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Department of Dermatology Siriraj Hospital
Bangkok, , Thailand
Countries
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References
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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.
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.
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.
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.
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.
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.
Burkhart CG. Pitted keratolysis: a new form of treatment. Arch Dermatol. 1980 Oct;116(10):1104. No abstract available.
Balic A, Bukvic Mokos Z, Marinovic B, Ledic Drvar D. Tatami Mats: A Source of Pitted Keratolysis in a Martial Arts Athlete? Acta Dermatovenerol Croat. 2018 Apr;26(1):68-70.
Kontochristopoulos G, Sidiropoulou P, Tzanetakou V, Markantoni V, Platsidaki E, Agiasofitou E, Rigopoulos D, Gregoriou S. Managing pitted keratolysis: consider topical glycopyrrolate. Clin Exp Dermatol. 2019 Aug;44(6):713-714. doi: 10.1111/ced.13851. Epub 2018 Dec 4. No abstract available.
Pranteda G, Carlesimo M, Pranteda G, Abruzzese C, Grimaldi M, De Micco S, Muscianese M, Bottoni U. Pitted keratolysis, erythromycin, and hyperhidrosis. Dermatol Ther. 2014 Mar-Apr;27(2):101-4. doi: 10.1111/dth.12064. Epub 2013 May 24.
Greywal T, Cohen PR. Pitted keratolysis: successful management with mupirocin 2% ointment monotherapy. Dermatol Online J. 2015 Aug 15;21(8):13030/qt6155v9wk.
Vazquez-Lopez F, Perez-Oliva N. Mupirocine ointment for symptomatic pitted keratolysis. Infection. 1996 Jan-Feb;24(1):55. doi: 10.1007/BF01780656. No abstract available.
Tamura BM, Cuce LC, Souza RL, Levites J. Plantar hyperhidrosis and pitted keratolysis treated with botulinum toxin injection. Dermatol Surg. 2004 Dec;30(12 Pt 2):1510-4. doi: 10.1111/j.1524-4725.2004.30553.x.
Fiedot-Tobola M, Ciesielska M, Maliszewska I, Rac-Rumijowska O, Suchorska-Wozniak P, Teterycz H, Bryjak M. Deposition of Zinc Oxide on Different Polymer Textiles and Their Antibacterial Properties. Materials (Basel). 2018 Apr 30;11(5):707. doi: 10.3390/ma11050707.
Raghunath A, Perumal E. Metal oxide nanoparticles as antimicrobial agents: a promise for the future. Int J Antimicrob Agents. 2017 Feb;49(2):137-152. doi: 10.1016/j.ijantimicag.2016.11.011. Epub 2017 Jan 3.
Dizaj SM, Lotfipour F, Barzegar-Jalali M, Zarrintan MH, Adibkia K. Antimicrobial activity of the metals and metal oxide nanoparticles. Mater Sci Eng C Mater Biol Appl. 2014 Nov;44:278-84. doi: 10.1016/j.msec.2014.08.031. Epub 2014 Aug 16.
Other Identifiers
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zincoxide_PK
Identifier Type: -
Identifier Source: org_study_id
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