Ultrasonographic Evaluation of Cosmetic Keratolytic Treatment of Foot Calluses and Corns

NCT07765225 — Not applicable, Completed, 124 participants, Wroclaw University of Health and Sport Sciences

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT07765225
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, supportive care
Enrollment	124 (Actual)
Sponsor	Wroclaw University of Health and Sport Sciences (Other)
Conditions	Hyperkeratosis, Callus, Corn (Clavus), Foot Dermatoses
Interventions	Topical Keratolytic Cosmetic (Serum + Cream) (Other)
Dates	start 2020-02-01, primary completion 2026-03-01, completion 2026-05-01, first posted 2026-08-14, last updated 2026-08-14
Locations	1 site in Poland

-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). 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).

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
Calluses: Keratolytic Treatment	Experimental	Other: Topical Keratolytic Cosmetic (Serum + Cream)	Women with foot calluses applying the topical keratolytic cosmetic serum and cream twice daily for 2 months.
Calluses: Untreated Control	No intervention		Women with foot calluses receiving no topical treatment over the 2-month observation period
Corns: Keratolytic Treatment	Experimental	Other: Topical Keratolytic Cosmetic (Serum + Cream)	Women with foot corns applying the topical keratolytic cosmetic serum and cream twice daily for 2 months
Corns: Untreated Control	No intervention		Women with foot corns receiving no topical treatment over the 2-month observation period

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

+Outcome measures

Primary outcomes

Change in Hyperkeratotic Lesion Thickness [Baseline and 2 months]: Lesion thickness measured in centimetres using high-frequency ultrasonography (Esaote MyLab60 with an 18 MHz linear probe)

Secondary outcomes

Change in Lesion-Associated Pain [Baseline and 2 months]: Participant self-reported pain assessed on a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (worst imaginable pain).

+Eligibility

Sex: Female, ages: 35 Years to 65 Years

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

+Locations (1)

Facility	City	Country	Status
OSTEON Clinic	Swidnica	Poland

+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