An open label, single center, Investigator initiated, pilot study to determine the efficacy and safety of topical use of Dermatonics Heel Balm as compared to Moisturex cream for the Reduction/Removal of Hard Callused Plantar Skin.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Analysis of reduction in the callus on the basis of assessment scale
研究概览
简要总结
The study is a prospective, observational, single-center, two-arm, open label, pilot study to determine the efficacy and safety of investigational products for the reduction or removal of hard callused plantar skin. Participants will be selected as per the inclusion criteria. Participants will be asked not to use any additional moisturizing foot products on their feet or have any procedure done on their feet including pedicure. Participants will be instructed to use the products as suggested by the Investigator. Product (Dermatonics) will be applied on Left foot and Comparator (Moisturex) will be applied on Right Foot of each participant
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diabetic patients with dry and callused skin (Grading –1-5).
- •Subjects who are healthy with no significant concurrent illnesses or skin disease.
- •Subjects with visibly dry and rough skin on their heels.
- •Participants who will be able to provide written informed consent prior to the performance of any study specific procedures.
- •Female participants of child-bearing potential with negative serum pregnancy test at screening and negative urine pregnancy test at the time of screening.
- •Participants who are willing and able to comply with all study assessments and adhere to the protocol schedule.
排除标准
- •Pregnant or lactating females or females of reproductive age not using a reliable form of contraception.
- •Subjects who take any medication likely to interfere with the study.
- •Subjects with a history of significant skin disease (e.g. eczema, psoriasis)
- •Subjects with an allergy likely to interfere with the study.
- •Subjects who are unwilling or unable to give written consent.
- •Patients involved in clinical trials and taken Investigational drugs within 30 days of enrolment.
结局指标
主要结局
Analysis of reduction in the callus on the basis of assessment scale
时间窗: day 0, 1st and 3rd
with detailed photographs having following Grades-
时间窗: day 0, 1st and 3rd
➢ Grade 0: smooth, fine lines, and no dryness
时间窗: day 0, 1st and 3rd
➢ Grade 2: small fissures, moderate scaling, and skin thickening
时间窗: day 0, 1st and 3rd
➢ Grade 3: deep fissures, obvious scaling, and skin thickening
时间窗: day 0, 1st and 3rd
➢ Grade 4: small gaps on fissures, severe scaling, and skin
时间窗: day 0, 1st and 3rd
➢ Grade 1: dry lines, slight scaling, and skin thickening
时间窗: day 0, 1st and 3rd
thickening.
时间窗: day 0, 1st and 3rd
➢ Grade 5: Big gaps and Opening on Fissures, bleeding, extreme
时间窗: day 0, 1st and 3rd
scaling and skin thickening.
时间窗: day 0, 1st and 3rd
Improvement in Hydration based on “The Young Townson Foot
时间窗: day 0, 1st and 3rd
skin hydration scaleâ€. Graded as:
时间窗: day 0, 1st and 3rd
Level 1: Well hydrated heels, with little or no signs of drying,
时间窗: day 0, 1st and 3rd
Level 2: Drying skin but no callus,
时间窗: day 0, 1st and 3rd
Level 3: Drying skin combined with callus,
时间窗: day 0, 1st and 3rd
Level 4: Callused skin with open slits.
时间窗: day 0, 1st and 3rd
次要结局
- Improvement in General skin condition, skin colour and cracks.(Any discoloration or hyperpigmentation and change in cracks on)