NCT04332796

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 treatment of pitted keratolysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2022

Shorter than P25 for phase_4

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

April 1, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
1.9 years until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

April 1, 2020

Last Update Submit

May 23, 2023

Conditions

Foot Dermatoses

Keywords

Pitted keratolysisFoot OdorChlorhexidine solutionZinc oxide nanoparticles

Outcome Measures

Primary Outcomes (1)

  • The number of patients who had improvement of pitted lesion after treatment

    Effectiveness was evaluated

    4 weeks

Secondary Outcomes (1)

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

    4 weeks

Study Arms (3)

Chorhexidine scrub

ACTIVE COMPARATOR

Chorhexidine scrub was given to patients for 4 weeks

Drug: Chorhexidine scrub

ZnO-NPs socks

ACTIVE COMPARATOR

ZnO-NPs socks to patients for 4 weeks

Device: ZnO-NPs socks

Combination of chorhexidine scrub and ZnO-NPs socks

ACTIVE COMPARATOR

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

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

Interventions

Chorhexidine scrubDRUG

Chorhexidine scrub was given to patients for 4 weeks

Chorhexidine scrub
ZnO-NPs socksDEVICE

ZnO-NPs socks was given to patients for 4 weeks

ZnO-NPs socks
Combination of chorhexidine scrub and ZnO-NPs socksCOMBINATION_PRODUCT

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

Combination of chorhexidine scrub and ZnO-NPs socks

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology Siriraj Hospital

Bangkok, 10700, Thailand

Location

Related Publications (6)

  • 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

MeSH Terms

Conditions

Foot Dermatoses

Condition Hierarchy (Ancestors)

Foot DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sumanas Bunyaratavej, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Single blind controlled trial between participants, drug preparing team, doctors, investigators, and outcome assessors.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2020

First Posted

April 3, 2020

Study Start

March 15, 2022

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

May 25, 2023

Record last verified: 2023-05

Locations

TH(1)