Clinical trial

The Study of Foot-skin Microbiome and Metabolomics of Thai Naval Cadets With Pitted Keratolysis

NCT04781036

Name

PK microbiome and metabolomic

Description

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

Trial arms

Trial start

2023-05-01

Estimated PCD

2024-12-01

Trial end

2024-12-01

Status

Active (not recruiting)

Treatment

4%Chlorhexidine

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

Arms:

Foot odor with pitted keratolysis, Foot odor without pitted keratolysis

Size

250

Primary endpoint

Amount of skin microbiome

2 months

Composition of microbiota at skin

2 months

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 250, 'type': 'ESTIMATED'}}

Updated at

2024-03-18

1 organization

1 product

2 indications

Organization

Product

Indication

Indication