An interventional study of Topical Keratolytic Cosmetic (Serum + Cream) in Hyperkeratosis, Callus and Corn (Clavus), sponsored by Wroclaw University of Health and Sport Sciences. Completed at 1 site in Poland. Open to female participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Wroclaw University of Health and Sport Sciences · Not applicable, Interventional, and Supportive care
This prospective, non-randomized, controlled study evaluated the efficacy of a topical cosmetic keratolytic preparation (serum and cream containing urea, salicylic acid, and collagen) in reducing the thickness and associated pain of hyperkeratotic foot lesions (calluses and corns). High-frequency ultrasonography (18 MHz) was used for precise, quantitative measurement of lesion thickness before and after a two-month intervention. Participants were allocated to four parallel groups (treated calluses, untreated callus controls, treated corns, and untreated corn controls).
A total of 124 women aged 35-65 years, each presenting with a single non-infectious hyperkeratotic foot lesion, were allocated by lesion type (callus or corn) and by intervention (treated vs untreated), forming four parallel groups of 31. Treated participants applied 2 mL of serum followed by 2 mL of cream, each massaged into the lesion for two minutes, twice daily for two months. Untreated controls received no topical intervention over the same period. Lesion thickness (cm) was measured with an Esaote MyLab60 system and an 18 MHz linear probe, and pain was self-reported on a 0-10 visual analogue scale, at baseline and after two months. Within-group changes were analysed with the Wilcoxon signed-rank test and between-group reductions with the Mann-Whitney U test.
21 studies on the registry are indexed under Callosities; 1 is open to participants now.
This study's enrollment of 124 is above the median of 60 across 19 interventional studies indexed under Callosities.
Browse Callosities studies →Wroclaw University of Health and Sport Sciences is the lead sponsor of 46 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women with foot calluses applying the topical keratolytic cosmetic serum and cream twice daily for 2 months.
Other: Topical Keratolytic Cosmetic (Serum + Cream)
Women with foot calluses receiving no topical treatment over the 2-month observation period
Women with foot corns applying the topical keratolytic cosmetic serum and cream twice daily for 2 months
Other: Topical Keratolytic Cosmetic (Serum + Cream)
Women with foot corns receiving no topical treatment over the 2-month observation period
Application of 2 mL serum followed by 2 mL cream containing urea, salicylic acid, and collagen, massaged into the hyperkeratotic lesion for 2 minutes, twice daily (morning and evening) for 2 months
Change in Hyperkeratotic Lesion Thickness
Lesion thickness measured in centimetres using high-frequency ultrasonography (Esaote MyLab60 with an 18 MHz linear probe)
Time frame: Baseline and 2 months
Change in Lesion-Associated Pain
Participant self-reported pain assessed on a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (worst imaginable pain).
Time frame: Baseline and 2 months
Plan to share: Yes — De-identified individual participant data (lesion thickness measurements and VAS pain scores, before and after the intervention) underlying the results reported in the associated publication will be made available.
Supporting information: Study protocol
Time frame: Beginning after publication of the main results, with no planned end date
Access criteria: Available to qualified researchers on reasonable request to the corresponding author (agnieszka.ciszek@awf.wroc.pl)
Ran from Feb 2020 to primary completion in Mar 2026, 73 months.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Wroclaw University of Health and Sport Sciences