Ultrasonographic Evaluation of Cosmetic Keratolytic Treatment of Foot Calluses and Corns

NCT07765225 | Completed

• 1 other identifier: KEBN-23-02-14
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hyperkeratosis; Callus; Corn (Clavus); Foot Dermatoses

Keywords

high-frequency ultrasonography; keratolytic; urea; salicylic acid; collagen; podiatry; foot skin lesions

Outcome Measures

Primary Outcomes (1)

• Change in Hyperkeratotic Lesion Thickness

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

  Baseline and 2 months

Secondary Outcomes (1)

• Change in Lesion-Associated Pain

  Baseline and 2 months

Study Arms (4)

Calluses: Keratolytic Treatment

EXPERIMENTAL

Women with foot calluses applying the topical keratolytic cosmetic serum and cream twice daily for 2 months.

Other: Topical Keratolytic Cosmetic (Serum + Cream)

Calluses: Untreated Control

NO INTERVENTION

Women with foot calluses receiving no topical treatment over the 2-month observation period

Corns: Keratolytic Treatment

EXPERIMENTAL

Women with foot corns applying the topical keratolytic cosmetic serum and cream twice daily for 2 months

Other: Topical Keratolytic Cosmetic (Serum + Cream)

Corns: Untreated Control

NO INTERVENTION

Women with foot corns receiving no topical treatment over the 2-month observation period

Interventions

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

Calluses: Keratolytic Treatment; Corns: Keratolytic Treatment

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead

Study Sites (1)

OSTEON Clinic

Swidnica, Poland

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Keratoderma, Palmoplantar, Epidermolytic; Callosities; Foot Dermatoses

Condition Hierarchy (Ancestors)

Keratoderma, Palmoplantar, Diffuse; Keratoderma, Palmoplantar; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Foot Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start: February 1, 2020
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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)

Locations

PL (1)