Chlorhexidine Scrub, ZnO Nanoparticles Socks and the Combination for Treatment of Pitted Keratolysis (PK_treatment)
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ClinicalTrials.gov Identifier: NCT04332796 |
Recruitment Status :
Not yet recruiting
First Posted : April 3, 2020
Last Update Posted : February 25, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Foot Dermatoses | Drug: Chorhexidine scrub Device: ZnO-NPs socks Combination Product: Combination of chorhexidine scrub and ZnO-NPs socks | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 72 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Masking Description: | Single blind controlled trial between participants, drug preparing team, doctors, investigators, and outcome assessors. |
Primary Purpose: | Treatment |
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 |
Estimated Study Start Date : | September 5, 2021 |
Estimated Primary Completion Date : | June 1, 2022 |
Estimated Study Completion Date : | October 1, 2022 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Chorhexidine scrub
Chorhexidine scrub was given to patients for 2 weeks
|
Drug: Chorhexidine scrub
Chorhexidine scrub was given to patients for 2 weeks |
Active Comparator: ZnO-NPs socks
ZnO-NPs socks to patients for 2 weeks
|
Device: ZnO-NPs socks
ZnO-NPs socks was given to patients for 2 weeks |
Active Comparator: Combination of chorhexidine scrub and ZnO-NPs socks
Chorhexidine scrub and ZnO-NPs socks to patients for 2 weeks
|
Combination Product: Combination of chorhexidine scrub and ZnO-NPs socks
Combination of chorhexidine scrub and ZnO-NPs socks was given to patients for 2 weeks |
- The number of patients who had improvement of pitted lesion after treatment [ Time Frame: 2 weeks ]Effectiveness was evaluated
- The percentage of patients developed any side effect such as erythema, burning [ Time Frame: 2 weeks ]Side effects was assessed

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- First-year naval rating cadets, who had pitted keratolysis
Exclusion Criteria:
- The cadets who previously received any topical treatment including topical antibiotic, antiperspirant or aluminum chloride within 6 months prior to the study.

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): NCT04332796
Contact: Charussri Leeyaphan, MD | +6624194333 | charussrilee@gmail.com | |
Contact: Sumanas Bunyaratavej, MD | +6624194333 | consultskin@yahoo.com |
Thailand | |
Department of Dermatology Siriraj Hospital | |
Bangkok, Thailand, 10700 |
Responsible Party: | Mahidol University |
ClinicalTrials.gov Identifier: | NCT04332796 |
Other Study ID Numbers: |
PK_treatment |
First Posted: | April 3, 2020 Key Record Dates |
Last Update Posted: | February 25, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pitted keratolysis Foot Odor Chlorhexidine solution Zinc oxide nanoparticles |
Skin Diseases Foot Dermatoses Foot Diseases Benzalkonium Compounds |
Benzethonium Anti-Infective Agents, Local Anti-Infective Agents |