A Study of Efficacy of Benzoyl Peroxide Regimens in Treatment of Unpleasant Foot Odor

September 11, 2022 updated by: Mahidol University
This study aimed to study the efficacy of topical 2.5% benzoyl peroxide, compared to 5% benzoyl peroxide in treatment of unpleasant foot odor, which was considered as major problem related to pitted keratolysis.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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,9 erythromycin gel, clindamycin solution, chlorhexidine scrub4 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.

Topical benzoyl peroxide is an over-the-counter drug and is known as off-label medication for pitted keratolysis. It has both aerobic and anaerobic antibacterial properties due to inhibition of various cell functions and the response against bacteria is dose related.15 In addition to antibacterial property, benzoyl peroxide can cause keratolysis. Previous studies by Vlahovic et al. (2009) and Balic et al. (2018) demonstrated efficacy of combination of 1% clindamycin and 5% benzoyl peroxide gel in pitted keratolysis. However, study of efficacy of topical benzoyl peroxide alone or comparison between 2.5% and 5% benzoyl peroxide gel for the treatment of pitted keratolysis is currently limited.

Objective The present study aimed to study the efficacy of topical 2.5% benzoyl peroxide, compared to 5% benzoyl peroxide in treatment of unpleasant foot odor, which was considered as major problem related to pitted keratolysis.

Material and Methods First-year naval rating cadets, who had pedal malodor 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 2.5% benzoyl peroxide gel or 5% benzoyl peroxide gel for 2 weeks. Benzoyl peroxide gel in this study comprised benzoyl peroxide in a gel base. During the study, using of other topical treatment such as topical antibiotics, antiperspirant or aluminum chloride was not allowed. Participants were advised to apply the drug on their both soles once per day before bedtime to leave it on and 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 PASW Statistics version 18 (SPSS, Inc., Chicago, IL, USA). Duration of study: 3 months Study design: Randomized control trial

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Department of Dermatology Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • First-year naval rating cadets, who had pedal malodor

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2.5% benzoyl peroxide
43 patients with 2.5% benzoyl peroxide gel
Drug: 2.5% benzoyl peroxide gel
2.5% benzoyl peroxide gel was given to patients for 2 weeks
Active Comparator: 5% benzoyl peroxide
43 patients with 5% benzoyl peroxide gel
Drug: 5% benzoyl peroxide gel
5% benzoyl peroxide gel was given to patients for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of topical 2.5% benzoyl peroxide, compared to 5% benzoyl peroxide in treatment of unpleasant foot odor
Time Frame: 2 weeks
Effectiveness was evaluated by the number of patients who had no or minimal foot odor after treatment
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate side effects of topical 2.5% benzoyl peroxide, compared to 5% benzoyl peroxide
Time Frame: 2 weeks
Side effects was assessed by the percentage of patients developed any side effect such as erythema, burning sensation, pain.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2019

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

June 26, 2019

First Submitted That Met QC Criteria

June 26, 2019

First Posted (Actual)

June 27, 2019

Study Record Updates

Last Update Posted (Actual)

September 15, 2022

Last Update Submitted That Met QC Criteria

September 11, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • benzoylperoxide_PK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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