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Completed

NCT Number: NCT07765225

Ultrasonographic Evaluation of Cosmetic Keratolytic Treatment of Foot 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).

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Key information

Conditions

Hyperkeratosis Callosities Callus Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corn (Clavus) Foot Dermatoses Foot Diseases Genetic Diseases, Inborn Keratoderma, Palmoplantar Keratoderma, Palmoplantar, Diffuse Keratoderma, Palmoplantar, Epidermolytic Keratosis Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

35 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

OSTEON Clinic

Swidnica, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Change in Hyperkeratotic Lesion Thickness

    Time frame: Baseline and 2 months

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

Secondary outcomes

  1. Change in Lesion-Associated Pain

    Time frame: Baseline and 2 months

    Participant self-reported pain assessed on a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (worst imaginable pain).

Sponsors and collaborators

Lead sponsor

Wroclaw University of Health and Sport Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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