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HyperkeratosisNCT07765225

Ultrasonographic Evaluation of Cosmetic Keratolytic Treatment of Foot Calluses and Corns

A study testing Topical Keratolytic Cosmetic (Serum + Cream) in people with Hyperkeratosis and Callus, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 35 to 65 years, women only
Conditions the study is for
Hyperkeratosis, Callus, Corn (Clavus)
What is being tested?
Topical Keratolytic Cosmetic (Serum + Cream)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 sitePoland
Study dates
1 Feb 2020to 1 May 2026
Phase
Interventional
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 35 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult women aged 35-65 years.
  • Presence of a single non-infectious hyperkeratotic foot lesion classified as either a callus or a corn.
  • Written informed consent provided prior to study initiation.

Who cannot join

  • Known allergy or hypersensitivity to salicylic acid, salicylates, or other formulation ingredients.
  • Active dermatological conditions, skin diseases, or epidermal fissures on the lower extremities.
  • Diabetes mellitus.
  • Active cardiovascular disorders or local inflammatory conditions.

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • OSTEON Clinic

    Swidnica

Other trials in Poland

About this study

Official title: Ultrasonographic Evaluation of Cosmetic Keratolytic Treatment of Hyperkeratotic Foot Lesions: A Prospective, Non-randomized, Controlled, Comparative Study of Calluses and Corns

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).

Read the detailed description

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.

Being tested
Topical Keratolytic Cosmetic (Serum + Cream)
Keywords
high-frequency ultrasonography, keratolytic, urea, salicylic acid, collagen, podiatry, foot skin lesions
Medical subject headings
Keratoderma, Palmoplantar, Epidermolytic, Callosities, Foot Dermatoses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Topical Keratolytic Cosmetic (Serum + Cream)Other

    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

Study groups in NCT07765225
Study groupRoleWhat they receive
Calluses: Keratolytic TreatmentExperimentalWomen with foot calluses applying the topical keratolytic cosmetic serum and cream twice daily for 2 months.
Receives: Other: Topical Keratolytic Cosmetic (Serum + Cream)
Calluses: Untreated ControlNo interventionWomen with foot calluses receiving no topical treatment over the 2-month observation period
Corns: Keratolytic TreatmentExperimentalWomen with foot corns applying the topical keratolytic cosmetic serum and cream twice daily for 2 months
Receives: Other: Topical Keratolytic Cosmetic (Serum + Cream)
Corns: Untreated ControlNo interventionWomen with foot corns receiving no topical treatment over the 2-month observation period

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Hyperkeratotic Lesion Thickness

    Lesion thickness measured in centimetres using high-frequency ultrasonography (Esaote MyLab60 with an 18 MHz linear probe)

    Measured: Baseline and 2 months

Secondary outcomes (1)

  1. 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).

    Measured: Baseline and 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2026
  2. Study start1 Feb 2020
  3. Primary completion1 Mar 2026
  4. Study completion1 May 2026

Resources

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 N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07765225
Sponsor's protocol ID
KEBN-23-02-14
Status last verified
Aug 2026
First submitted
10 Aug 2026
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • 1. Wortsman, X. Expanding dermatologic ultrasonography applications: further insights for enhanced patient management. Ultrasonography 42 (3), 476-477. https://doi.org/10.14366/usg.23082 (2023). 2. Bader, D. & Worsley, P. Technologies to monitor the health of loaded skin tissues. Biomed. Eng. Online 17 (1), 40-59. https://doi.org/10.1186/s12938-018-0457 (2018). 3. Benedetti, J. Diagnostic tests for skin disorders. MSD Manual Professional Edition (2024). 4. National Institute of Biomedical Imaging and Bioengineering. Ultrasound. NIBIB (Bethesda, MD). 5. Bhatta, A. et al. Application of high-frequency ultrasound in dermatology. Discov. Med. 26 (145), 237-242 (2018). 6. Cheng, X. et al. High-frequency ultrasound in blistering skin diseases: a useful method for differentiating blister locations. J. Ultrasound Med. 36 (11), 2367-2371. https://doi.org/10.1002/jum.14302 (2017). 7. Cohen, P. R. & Anderson, C. A. Topical selenium sulfide for the treatment of hyperkeratosis. Dermatol. Ther. (Heidelb.) 8 (4), 639-646. https://doi.org/10.1007/s13555-018-0247-2 (2018). 8. Wortsman, X. Top applications of dermatologic ultrasonography that can modify management. Ultrasonography 42, 183-202. https://doi.org/10.14366/usg.22130 (2023). 9. Argalia, G. et al. High-frequency and ultra-high-frequency ultrasound in dermatologic diseases and aesthetic medicine. Medicina (Kaunas) 61 (2), 220. https://doi.org/10.3390/medicina61020220 (2025). 10. Cisoń, H. & Białynicki-Birula, R. High-frequency ultrasonography: one of the modern imaging diagnostic methods in dermatology. Authors' own experience and review. Adv. Dermatol. Allergol. 41 (3), 306-313. https://doi.org/10.5114/ada.2024.141108 (2024). 11. Wang, Q. et al. Role of high-frequency ultrasound in differentiating benign and malignant skin lesions: potential and limitations. Ultrasonography 43 (4), 238-249. https://doi.org/10.14366/usg.24015 (2024). 12. Jaguś, D., Malinowska, S. & Mlosek, R. Skin ultrasound diagnostics in beauty parlour. Ae

Questions about this trial

What is this clinical trial studying?

A study testing Topical Keratolytic Cosmetic (Serum + Cream) in people with Hyperkeratosis and Callus, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.

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 3 inclusion and 4 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 14 Aug 2026. 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 Poland. 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.

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?

Change in Hyperkeratotic Lesion Thickness (time frame: Baseline and 2 months). 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 NCT07765225, which also lists 1 linked publication.

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 14 Aug 2026.

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