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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04337749
Recruitment Status : Not yet recruiting
First Posted : April 8, 2020
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Mahidol University

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.

Condition or disease Intervention/treatment Phase
Foot Dermatoses Drug: Chorhexidine scrub Device: ZnO-NPs socks Combination Product: Combination of chorhexidine scrub and ZnO-NPs socks Device: Placebo socks Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 316 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Single blind controlled trial between participants, drug preparing team, doctors, investigators, and outcome assessors.
Primary Purpose: Prevention
Official Title: A Study of Efficacy of Chlorhexidine Scrub, ZnO Nanoparticles Socks and the Combination of Chlorhexidine Scrub and ZnO Nanoparticles Socks for Prevention of Pitted Keratolysis
Estimated Study Start Date : May 5, 2020
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Active Comparator: Chorhexidine scrub
Chorhexidine scrub was given to participants for 2 weeks
Drug: Chorhexidine scrub
Chorhexidine scrub was given to patients for 2 weeks

Active Comparator: ZnO-NPs socks
ZnO-NPs socks were given to participants for 2 weeks
Device: ZnO-NPs socks
ZnO-NPs socks were given to patients for 2 weeks

Active Comparator: Combination of chorhexidine scrub and ZnO-NPs socks
Chorhexidine scrub and ZnO-NPs socks were given to participants for 2 weeks
Combination Product: Combination of chorhexidine scrub and ZnO-NPs socks
Combination of chorhexidine scrub and ZnO-NPs socks were given to patients for 2 weeks

Placebo Comparator: Placebo
Placebo socks were given to participants for 2 weeks
Device: Placebo socks
Placebo socks were given to patients for 2 weeks




Primary Outcome Measures :
  1. The number of patients who had pitted keratolysis after treatment [ Time Frame: 2 weeks ]
    Effectiveness was evaluated


Secondary Outcome Measures :
  1. The percentage of patients developed any side effect such as erythema, burning [ Time Frame: 2 weeks ]
    Side effects were assessed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04337749


Contacts
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Contact: Charussri Leeyaphan, MD +6624194333 charussrilee@gmail.com
Contact: Sumanas Bunyaratavej, MD +6624194333 consultskin@yahoo.com

Locations
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Thailand
Department of Dermatology Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Publications of Results:

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT04337749    
Other Study ID Numbers: PK_prevention
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahidol University:
Pitted keratolysis
Prevention
Chlorhexidine solution
Zinc oxide nanoparticles
Additional relevant MeSH terms:
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Skin Diseases
Foot Dermatoses
Foot Diseases
Benzalkonium Compounds
Benzethonium
Anti-Infective Agents, Local
Anti-Infective Agents