NCT04000386

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

June 26, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2021

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

1.6 years

First QC Date

June 26, 2019

Last Update Submit

February 25, 2021

Conditions

Zinc OxideFoot Dermatoses

Keywords

Pitted keratolysiszinc oxideFoot Odorpreventsion

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of zinc oxide nanoparticles coated socks in prevention of unpleasant foot odor

    Effectiveness was evaluated by the number of patients who had no or minimal foot odor after prevention

    2 weeks

Secondary Outcomes (1)

  • Effectiveness of zinc oxide nanoparticles coated socks in prevention of fungal feet infection

    2 weeks

Study Arms (2)

zinc oxide nanoparticles coated socks

EXPERIMENTAL

62 patients with zinc oxide nanoparticles coated socks

Other: zinc oxide nanoparticles coated socks

placebo

PLACEBO COMPARATOR

62 patients with placebo socks

Other: placebo socks

Interventions

zinc oxide nanoparticles coated socksOTHER

zinc oxide nanoparticles coated socks were given to subjects for 2 weeks

zinc oxide nanoparticles coated socks
placebo socksOTHER

placebo socks were given to subjects for 2 weeks

placebo

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First-year naval rating cadets, who had no pedal malodor

You may not qualify if:

  • The cadets who previously received any topical treatment including topical antibiotic, antiperspirant or aluminum chloride within 6 months prior to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology Siriraj Hospital

Bangkok, 10700, Thailand

Location

Related Publications (16)

  • 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.

    PMID: 26982791RESULT

  • 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.

    PMID: 28924971RESULT

  • 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.

    PMID: 22882561RESULT

  • 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.

    PMID: 30415588RESULT

  • 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.

    PMID: 19935134RESULT

  • 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.

    PMID: 29951993RESULT

  • Burkhart CG. Pitted keratolysis: a new form of treatment. Arch Dermatol. 1980 Oct;116(10):1104. No abstract available.

    PMID: 7425659RESULT

  • 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.

    PMID: 29782305RESULT

  • 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.

    PMID: 30515854RESULT

  • 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.

    PMID: 24703267RESULT

  • Greywal T, Cohen PR. Pitted keratolysis: successful management with mupirocin 2% ointment monotherapy. Dermatol Online J. 2015 Aug 15;21(8):13030/qt6155v9wk.

    PMID: 26437161RESULT

  • 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.

    PMID: 8852468RESULT

  • 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.

    PMID: 15606827RESULT

  • 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.

    PMID: 29710873RESULT

  • 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.

    PMID: 28089172RESULT

  • 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.

    PMID: 25280707RESULT

MeSH Terms

Conditions

Foot Dermatoses

Condition Hierarchy (Ancestors)

Foot DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single (Participant) Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Single blind controlled trial between participants, drug preparing team, doctors, investigators, and outcome assessors.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2019

First Posted

June 27, 2019

Study Start

June 26, 2019

Primary Completion

February 1, 2021

Study Completion

February 25, 2021

Last Updated

March 1, 2021

Record last verified: 2021-02

Locations

TH(1)