Callus, Corn (Clavus), Foot Dermatoses, Hyperkeratosis
Conditions
Keywords
high-frequency ultrasonography, keratolytic, urea, salicylic acid, collagen, podiatry, foot skin lesions
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).
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.
Interventions
OTHERTopical Keratolytic Cosmetic (Serum + Cream)
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
Sponsors
Wroclaw University of Health and Sport Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Poland
Outcome results
None listed