Foot DermatosesPhase 4PK_treatmentNCT04332796
Chlorhexidine Scrub, ZnO Nanoparticles Socks and the Combination for Treatment of Pitted Keratolysis
A Phase 4 study testing Chorhexidine scrub, ZnO-NPs socks and Combination of chorhexidine scrub and ZnO-NPs socks in people with Foot Dermatoses, run by Mahidol University at 1 site in Thailand.
Trial 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 treatment of pitted keratolysis. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Foot Dermatoses
- What is being tested?
- Chorhexidine scrub, ZnO-NPs socks and Combination of chorhexidine scrub and ZnO-NPs socks
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 15 Mar 2022to 1 Nov 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male security guards and hospital porters , who had pitted keratolysis
Who cannot join
- Male security guards and hospital porters who previously received any topical treatment including topical antibiotic, antiperspirant or aluminum chloride within 2 weeks prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Efficacy of Chlorhexidine Scrub, ZnO Nanoparticles Socks and the Combination of Chlorhexidine Scrub and ZnO Nanoparticles Socks for Treatment of Pitted Keratolysis
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 treatment of pitted keratolysis.
Read the 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 treatment of pitted keratolysis.
Material and Methods Male security guards and hospital porters , who had pitted keratolysis were invited to enroll in this study. The security guards and hospital porters who previously received any topical treatment including topical antibiotic, antiperspirant or aluminum chloride within 2 weeks 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 and the combination of chlorhexidine scrub and ZnO-NPs socks for 4 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 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. Four 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 (a decrease of less than 50% in the number of pitted lesions) and much improvement (a decrease of 50% or above in the number of pitted lesions). Data were analyzed using SPSS version 18 (SPSS, Inc., Chicago, IL, USA).
Duration of study: 6 months Study design: Randomized control trial
- Conditions
- Foot Dermatoses
- Being tested
- Chorhexidine scrub, ZnO-NPs socks, Combination of chorhexidine scrub and ZnO-NPs socks
- Keywords
- Pitted keratolysis, Foot Odor, Chlorhexidine solution, Zinc oxide nanoparticles
- Medical subject headings
- Foot Dermatoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chorhexidine scrubDrug
Chorhexidine scrub was given to patients for 4 weeks
ZnO-NPs socksDevice
ZnO-NPs socks was given to patients for 4 weeks
Combination of chorhexidine scrub and ZnO-NPs socksCombination product
Combination of chorhexidine scrub and ZnO-NPs socks was given to patients for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Chorhexidine scrub | Active comparator | Chorhexidine scrub was given to patients for 4 weeks Receives: Drug: Chorhexidine scrub |
| ZnO-NPs socks | Active comparator | ZnO-NPs socks to patients for 4 weeks Receives: Device: ZnO-NPs socks |
| Combination of chorhexidine scrub and ZnO-NPs socks | Active comparator | Chorhexidine scrub and ZnO-NPs socks to patients for 4 weeks Receives: Combination Product: Combination of chorhexidine scrub and ZnO-NPs socks |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients who had improvement of pitted lesion after treatment
Effectiveness was evaluated
Measured: 4 weeks
Secondary outcomes (1)
The percentage of patients developed any side effect such as erythema, burning
Side effects was assessed
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start15 Mar 2022
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Foot DermatosesStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumanas Bunyaratavej, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332796
- Sponsor's protocol ID
- PK_treatment
- Acronym
- PK_treatment
- Status last verified
- May 2023
- First submitted
- 1 Apr 2020
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
de Almeida HL Jr, Siqueira RN, Meireles Rda S, Rampon G, de Castro LA, Silva RM. Pitted keratolysis. An Bras Dermatol. 2016 Jan-Feb;91(1):106-8. doi: 10.1590/abd1806-4841.20164096.
PubMed 26982791Makhecha M, Dass S, Singh T, Gandhi R, Yadav T, Rathod D. Pitted keratolysis - a study of various clinical manifestations. Int J Dermatol. 2017 Nov;56(11):1154-1160. doi: 10.1111/ijd.13744. Epub 2017 Sep 18.
PubMed 28924971van der Snoek EM, Ekkelenkamp MB, Suykerbuyk JC. Pitted keratolysis; physicians' treatment and their perceptions in Dutch army personnel. J Eur Acad Dermatol Venereol. 2013 Sep;27(9):1120-6. doi: 10.1111/j.1468-3083.2012.04674.x. Epub 2012 Aug 7.
PubMed 22882561Leeyaphan C, Bunyaratavej S, Taychakhoonavudh S, Kulthanachairojana N, Pattanaprichakul P, Chanyachailert P, Ongsri P, Arunkajohnsak S, Limphoka P, Kulthanan K. Cost-effectiveness analysis and safety of erythromycin 4% gel and 4% chlorhexidine scrub for pitted keratolysis treatment. J Dermatolog Treat. 2019 Sep;30(6):627-629. doi: 10.1080/09546634.2018.1543846. Epub 2018 Dec 11.
PubMed 30415588Vlahovic TC, Dunn SP, Kemp K. The use of a clindamycin 1%-benzoyl peroxide 5% topical gel in the treatment of pitted keratolysis: a novel therapy. Adv Skin Wound Care. 2009 Dec;22(12):564-6. doi: 10.1097/01.ASW.0000363468.18117.fe. No abstract available.
PubMed 19935134Bunyaratavej S, Leeyaphan C, Chanyachailert P, Pattanaprichakul P, Ongsri P, Kulthanan K. Clinical manifestations, risk factors and quality of life in patients with pitted keratolysis: a cross-sectional study in cadets. Br J Dermatol. 2018 Nov;179(5):1220-1221. doi: 10.1111/bjd.16923. Epub 2018 Sep 14. No abstract available.
PubMed 29951993
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Efficacy of Chlorhexidine Scrub, ZnO Nanoparticles Socks and the Combination of Chlorhexidine Scrub and ZnO Nanoparticles Socks for Treatment of Pitted Keratolysis
- ClinicalTrials.gov ID
- NCT04332796
- Acronym / sponsor ID
- PK_treatment / PK_treatment
- Conditions
- Foot Dermatoses
- Keywords
- Pitted keratolysis, Foot Odor, Chlorhexidine solution, Zinc oxide nanoparticles
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 3 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 treatment 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 treatment of pitted keratolysis.
Material and Methods Male security guards and hospital porters , who had pitted keratolysis were invited to enroll in this study. The security guards and hospital porters who previously received any topical treatment including topical antibiotic, antiperspirant or aluminum chloride within 2 weeks 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 and the combination of chlorhexidine scrub and ZnO-NPs socks for 4 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 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. Four 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 (a decrease of less than 50% in the number of pitted lesions) and much improvement (a decrease of 50% or above in the number of pitted lesions). Data were analyzed using SPSS version 18 (SPSS, Inc., Chicago, IL, USA).
Duration of study: 6 months Study design: Randomized control trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chorhexidine scrub | Active comparator | Drug: Chorhexidine scrubChorhexidine scrub was given to patients for 4 weeks |
| ZnO-NPs socks | Active comparator | Device: ZnO-NPs socksZnO-NPs socks to patients for 4 weeks |
| Combination of chorhexidine scrub and ZnO-NPs socks | Active comparator | Combination Product: Combination of chorhexidine scrub and ZnO-NPs socksChorhexidine scrub and ZnO-NPs socks to patients for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male security guards and hospital porters , who had pitted keratolysis
Key exclusion criteria (1 listed)
- Male security guards and hospital porters who previously received any topical treatment including topical antibiotic, antiperspirant or aluminum chloride within 2 weeks prior to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chorhexidine scrubChorhexidine scrub was given to patients for 4 weeks | Drug | Chorhexidine scrub |
| ZnO-NPs socksZnO-NPs socks was given to patients for 4 weeks | Device | ZnO-NPs socks |
| Combination of chorhexidine scrub and ZnO-NPs socksCombination of chorhexidine scrub and ZnO-NPs socks was given to patients for 4 weeks | Combination product | Combination of chorhexidine scrub and ZnO-NPs socks |
Primary outcome
The number of patients who had improvement of pitted lesion after treatment
Time frame: 4 weeks
Effectiveness was evaluated
1 secondary outcome
The percentage of patients developed any side effect such as erythema, burning
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Results publication: PubMed 26982791de Almeida HL Jr, Siqueira RN, Meireles Rda S, Rampon G, de Castro LA, Silva RM. Pitted keratolysis. An Bras Dermatol. 2016 Jan-Feb;91(1):106-8. doi: 10.1590/abd1806-4841.20164096.
- Results publication: PubMed 28924971Makhecha M, Dass S, Singh T, Gandhi R, Yadav T, Rathod D. Pitted keratolysis - a study of various clinical manifestations. Int J Dermatol. 2017 Nov;56(11):1154-1160. doi: 10.1111/ijd.13744. Epub 2017 Sep 18.
- Results publication: PubMed 22882561van der Snoek EM, Ekkelenkamp MB, Suykerbuyk JC. Pitted keratolysis; physicians' treatment and their perceptions in Dutch army personnel. J Eur Acad Dermatol Venereol. 2013 Sep;27(9):1120-6. doi: 10.1111/j.1468-3083.2012.04674.x. Epub 2012 Aug 7.
- Results publication: PubMed 30415588Leeyaphan C, Bunyaratavej S, Taychakhoonavudh S, Kulthanachairojana N, Pattanaprichakul P, Chanyachailert P, Ongsri P, Arunkajohnsak S, Limphoka P, Kulthanan K. Cost-effectiveness analysis and safety of erythromycin 4% gel and 4% chlorhexidine scrub for pitted keratolysis treatment. J Dermatolog Treat. 2019 Sep;30(6):627-629. doi: 10.1080/09546634.2018.1543846. Epub 2018 Dec 11.
- Results publication: PubMed 19935134Vlahovic TC, Dunn SP, Kemp K. The use of a clindamycin 1%-benzoyl peroxide 5% topical gel in the treatment of pitted keratolysis: a novel therapy. Adv Skin Wound Care. 2009 Dec;22(12):564-6. doi: 10.1097/01.ASW.0000363468.18117.fe. No abstract available.
- Results publication: PubMed 29951993Bunyaratavej S, Leeyaphan C, Chanyachailert P, Pattanaprichakul P, Ongsri P, Kulthanan K. Clinical manifestations, risk factors and quality of life in patients with pitted keratolysis: a cross-sectional study in cadets. Br J Dermatol. 2018 Nov;179(5):1220-1221. doi: 10.1111/bjd.16923. Epub 2018 Sep 14. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sumanas Bunyaratavej, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chorhexidine scrub, ZnO-NPs socks and Combination of chorhexidine scrub and ZnO-NPs socks in people with Foot Dermatoses, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients who had improvement of pitted lesion after treatment (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04332796, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.