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

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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

Tracking Information
First Submitted Date  ICMJE April 5, 2020
First Posted Date  ICMJE April 8, 2020
Last Update Posted Date April 8, 2020
Estimated Study Start Date  ICMJE May 5, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2020)
The number of patients who had pitted keratolysis after treatment [ Time Frame: 2 weeks ]
Effectiveness was evaluated
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2020)
The percentage of patients developed any side effect such as erythema, burning [ Time Frame: 2 weeks ]
Side effects were assessed
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chlorhexidine Scrub, ZnO Nanoparticles Socks and the Combination for Prevention of Pitted Keratolysis
Official Title  ICMJE 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
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.
Detailed Description

Introduction Pitted keratolysis is a common skin disease, caused by various gram-positive bacteria including Corynebacterium species, Kytococcus sedentarius, Dermophilus congolensis and Actinomyces species. These bacteria create small tunnels in the stratum corneum, causing pitted lesions at plantar areas. This condition is frequent accompanied by feet malodor and is commonly found in young male adults, especially in soldiers, miners and athletes. The reported prevalence of pitted keratolysis among naval cadets in Thailand was 38.7%. Predisposing factors related to pitted keratolysis are pedal hyperhidrosis and prolonged feet occlusion. Although this condition is generally not painful, our previous study in 2018 revealed adversely affects patients' quality of life.

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 scrub 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.

Zinc oxide (ZnO) has been demonstrated to exhibit antimicrobial activities against many microorganisms, such as Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa and fungal infections including dermatophytosis. It has been proposed that the mechanism is the generation of reactive oxygen species, such as hydrogen peroxide, on microorganism cell surfaces, thereby causing membrane dysfunction. The antimicrobial activities have been observed to vary with changes in the physical and chemical properties of ZnO, for instance, its particle size, porosity and specific surface area.

Nanobiotechnology , which is the integration of biotechnology and nanotechnology, is currently being used in drug delivery systems. The bactericidal efficacy of ZnO nanoparticles (ZnO-NPs) has been shown to improves with a decrease in their particle size. ZnO has also been shown to be is safe and compatible with human skin, which makes it a suitable additive for textiles. Research by Choopong and Sarayut established that ZnO-NP-coated socks exhibited antimicrobial activities against gram-positive (S. aureus) and gram-negative (Klebsiella pneumoniae) bacteria.

Objective 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.

Material and Methods First-year naval rating cadets, who did not have pitted keratolysis were invited to enroll in this study. The cadets who previously received any topical treatment including topical antibiotic, antiperspirant or aluminum chloride within 6 months prior to the study were excluded. 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. Clinically examination of feet was done in all subjects by treatment-blinded dermatologists. Subjects were randomly assigned either chlorhexidine scrub, ZnO-NPs socks, the combination of chlorhexidine scrub and ZnO-NPs socks, or placebo socks for 2 weeks. During the study, using of other topical treatment such as topical antibiotics, antiperspirant or aluminum chloride was not allowed. Participants who received chlorhexidine scrub were advised to wash their both soles with chlorhexidine scrub two times per day in the morning and evening. Participants who received ZnO-NPs socks or placeblo socks were asked to wear these socks everyday and at least 8 hours per day. All were able to regularly participate in physical military training during the study. Two weeks after the treatment, 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 SPSS version 18 (SPSS, Inc., Chicago, IL, USA).

Duration of study: 6 months Study design: Randomized control trial

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Foot Dermatoses
Intervention  ICMJE
  • Drug: Chorhexidine scrub
    Chorhexidine scrub was given to patients for 2 weeks
  • Device: ZnO-NPs socks
    ZnO-NPs socks were given to patients 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
  • Device: Placebo socks
    Placebo socks were given to patients for 2 weeks
Study Arms  ICMJE
  • Active Comparator: Chorhexidine scrub
    Chorhexidine scrub was given to participants for 2 weeks
    Intervention: Drug: Chorhexidine scrub
  • Active Comparator: ZnO-NPs socks
    ZnO-NPs socks were given to participants for 2 weeks
    Intervention: Device: ZnO-NPs socks
  • Active Comparator: Combination of chorhexidine scrub and ZnO-NPs socks
    Chorhexidine scrub and ZnO-NPs socks were given to participants for 2 weeks
    Intervention: Combination Product: Combination of chorhexidine scrub and ZnO-NPs socks
  • Placebo Comparator: Placebo
    Placebo socks were given to participants for 2 weeks
    Intervention: Device: Placebo socks
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 5, 2020)
316
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Charussri Leeyaphan, MD +6624194333 charussrilee@gmail.com
Contact: Sumanas Bunyaratavej, MD +6624194333 consultskin@yahoo.com
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04337749
Other Study ID Numbers  ICMJE PK_prevention
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.
Responsible Party Mahidol University
Study Sponsor  ICMJE Mahidol University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mahidol University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP