Ultrasonographic Evaluation of Cosmetic Keratolytic Treatment of Hyperkeratotic Foot Lesions: A Prospective, Non-randomized, Controlled, Comparative Study of Calluses and Corns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Change in Hyperkeratotic Lesion Thickness
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Calluses: Keratolytic Treatment
Women with foot calluses applying the topical keratolytic cosmetic serum and cream twice daily for 2 months.
干预措施: 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
干预措施: Topical Keratolytic Cosmetic (Serum + Cream) (Other)
Corns: Untreated Control
Women with foot corns receiving no topical treatment over the 2-month observation period
结局指标
主要结局
Change in Hyperkeratotic Lesion Thickness
时间窗: Baseline and 2 months
Lesion thickness measured in centimetres using high-frequency ultrasonography (Esaote MyLab60 with an 18 MHz linear probe)
次要结局
- Change in Lesion-Associated Pain(Baseline and 2 months)
研究者
Agnieszka Ciszek
Assistant Professor
Wroclaw University of Health and Sport Sciences