Ultrasonographic Evaluation of Cosmetic Keratolytic Treatment of Hyperkeratotic Foot Lesions: A Prospective, Non-randomized, Controlled, Comparative Study of Calluses and Corns
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- Change in Hyperkeratotic Lesion Thickness
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts 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.
Arms & Interventions
Calluses: Keratolytic Treatment
Women with foot calluses applying the topical keratolytic cosmetic serum and cream twice daily for 2 months.
Intervention: Topical Keratolytic Cosmetic (Serum + Cream) (Other)
Calluses: Untreated Control
Women with foot calluses receiving no topical treatment over the 2-month observation period
Corns: Keratolytic Treatment
Women with foot corns applying the topical keratolytic cosmetic serum and cream twice daily for 2 months
Intervention: Topical Keratolytic Cosmetic (Serum + Cream) (Other)
Corns: Untreated Control
Women with foot corns receiving no topical treatment over the 2-month observation period
Outcomes
Primary Outcomes
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
- Change in Lesion-Associated Pain(Baseline and 2 months)
Investigators
Agnieszka Ciszek
Assistant Professor
Wroclaw University of Health and Sport Sciences