Foot-skin Microbiome and Metabolomics of Pitted Keratolysis

NCT04781036 | Active Not Recruiting

• 1 other identifier: PK microbiome and metabolomic
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

This study aimed to investigate the skin microbiome and metabolomics of patients with pitted keratolysis.

Conditions

Microbial Disease; Metabolomics

Keywords

Pitted keratolysis; Microbiome; Metabolomics

Outcome Measures

Primary Outcomes (2)

• Amount of skin microbiome

  Foot-skin microbial profiles of healthy Thai people and patients with pitted keratolysis

  2 months

• Composition of microbiota at skin

  Foot-skin microbial profiles of healthy Thai people and patients with pitted keratolysis

  2 months

Secondary Outcomes (1)

• Amount of metabolite in foot odor

  2 months

Study Arms (3)

Normal feet

NO INTERVENTION

* Swab their feet to analyze foot microbiome via 16s DNA sequencing * Collect their socks to analyze metabolomics via gas chromatography

Foot odor without pitted keratolysis

EXPERIMENTAL

* Swab their feet to analyze foot microbiome via 16s DNA sequencing * Collect their socks to analyze metabolomics via gas chromatography * Apply 4% chlorhexidine for 2 weeks * Re-evaluate their feet at time of treatment finish and 1 months after treatment finish. The forementioned methods (swab and collect their socks) will be applied on their feet again. * The microbiome and metabolomics will be analyzed to evaluate the difference of microbe and substances after treatment.

Drug: 4%Chlorhexidine

Foot odor with pitted keratolysis

EXPERIMENTAL

* Swab their feet to analyze foot microbiome via 16s DNA sequencing * Collect their socks to analyze metabolomics via gas chromatography * Apply 4% chlorhexidine for 2 weeks * Re-evaluate their feet at time of treatment finish and 1 months after treatment finish. The forementioned methods (swab and collect their socks) will be applied on their feet again. * The microbiome and metabolomics will be analyzed to evaluate the difference of microbe and substances after treatment.

Drug: 4%Chlorhexidine

Interventions

4%Chlorhexidine DRUG

4%Chlorhexidine was given to participants with foot odor for 2 weeks

Foot odor with pitted keratolysis; Foot odor without pitted keratolysis

Eligibility Criteria

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

You may qualify if:

• Naval rating cadets at Chumpol Naval Rating School, Thailand who volunteer to participate in this study. Informed consent will be obtained from all participants.
• Age ≥ 18 years.
• No underlying disease.
• Normal BMI (18.5-22.9 kg/m2).
• No previous history of pitted keratolysis.
• No previous history of dermatophytosis complex.
• Refrain from washing their feet for 12 hours prior to sampling.

You may not qualify if:

• Volunteers who have taken medication or topical antibiotics for pitted keratolysis within 2 weeks before the enrollment.
• Volunteers who have taken oral antibiotics within 2 weeks before enrollment.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (2)

Department of Dermatology Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

Department of Dermatology Siriraj Hospital

Bangkok, 10700, Thailand

Location

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Study Officials

• Sumanas Bunyaratavej, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 4, 2021
• Study Start: May 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (2)