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

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ClinicalTrials.gov Identifier: NCT04000347
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Benzoyl Peroxide Foot Dermatoses Drug: 2.5% benzoyl peroxide gel Drug: 5% benzoyl peroxide gel Phase 4

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Single blind controlled trial between participants, drug preparing team, doctors, investigators, and outcome assessors.
Primary Purpose: Treatment
Official Title: A Study of Efficacy of Benzoyl Peroxide Regimens in Treatment of Unpleasant Foot Odor
Actual Study Start Date : June 26, 2019
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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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 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.

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): NCT04000347


Contacts
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Contact: Charussri Leeyaphan, MD +664194333 charussrilee@gmail.com
Contact: Sumanas Bunyaratavej, MD +664194333 consultskin@yahoo.com

Locations
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Thailand
Department of Dermatology Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Contact: Sumanas Bunyaratavej, MD    : +664194333    consultskin@yahoo.com   
Contact: Charussri Leeyaphan,, MD    : +664194333    charussrilee@gmail.com   
Principal Investigator: Sumanas Bunyaratavej, MD         
Sub-Investigator: Charassri Leeyaphan, MD         
Sponsors and Collaborators
Mahidol University

Publications of Results:

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT04000347     History of Changes
Other Study ID Numbers: benzoylperoxide_PK
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by Mahidol University:
benzoyl peroxide
Pitted keratolysis
Foot Odor

Additional relevant MeSH terms:
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Skin Diseases
Foot Dermatoses
Foot Diseases
Benzoyl Peroxide
Dermatologic Agents