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

NCT04337749 | Withdrawn Phase 4

• 1 other identifier: PK_prevention
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 prevention of pitted keratolysis.

Conditions

Foot Dermatoses

Keywords

Pitted keratolysis; Prevention; Chlorhexidine solution; Zinc oxide nanoparticles

Outcome Measures

Primary Outcomes (1)

• The number of patients who had pitted keratolysis after treatment

  Effectiveness was evaluated

  2 weeks

Secondary Outcomes (1)

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

  2 weeks

Study Arms (4)

Chorhexidine scrub

ACTIVE COMPARATOR

Chorhexidine scrub was given to participants for 2 weeks

Drug: Chorhexidine scrub

ZnO-NPs socks

ACTIVE COMPARATOR

ZnO-NPs socks were given to participants for 2 weeks

Device: ZnO-NPs socks

Combination of chorhexidine scrub and ZnO-NPs socks

ACTIVE COMPARATOR

Chorhexidine scrub and ZnO-NPs socks were given to participants for 2 weeks

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

Placebo

PLACEBO COMPARATOR

Placebo socks were given to participants for 2 weeks

Device: Placebo socks

Interventions

Chorhexidine scrub DRUG

Chorhexidine scrub was given to patients for 2 weeks

Chorhexidine scrub

ZnO-NPs socks DEVICE

ZnO-NPs socks were given to patients for 2 weeks

ZnO-NPs socks

Combination of chorhexidine scrub and ZnO-NPs socks COMBINATION_PRODUCT

Combination of chorhexidine scrub and ZnO-NPs socks were given to patients for 2 weeks

Combination of chorhexidine scrub and ZnO-NPs socks

Placebo socks DEVICE

Placebo socks were given to patients for 2 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First-year naval rating cadets, who did not have pitted keratolysis

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.

Sponsors & Collaborators

• Mahidol University: lead

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: 26982791 RESULT

• 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: 28924971 RESULT

• 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: 22882561 RESULT

• 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: 30415588 RESULT

• 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: 19935134 RESULT

• 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: 29951993 RESULT

MeSH Terms

Conditions

Foot Dermatoses

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Charussri Leeyaphan, MD

  Department of Dermatology Faculty of Medicine, Siriraj Hospital Mahidol Universit

  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: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2020
• First Posted: April 8, 2020
• Study Start: November 5, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)