Study of Dermatonics Heel Balm compared to Moisturex cream for the Reduction/Removal of Hard Callused Plantar ski

Not Applicable

• Conditions: Health Condition 1: L84- Corns and callosities

• Registration Number: CTRI/2022/09/045825
• Lead Sponsor: Dr Anjeeta Dhawan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Diabetic patients with dry and callused skin (Grading ââ?¬â??1-5).

2. Subjects who are healthy with no significant concurrent illnesses or skin disease.

3. Subjects with visibly dry and rough skin on their heels.

4. Participants who will be able to provide written informed consent prior to the performance of any study specific procedures.

5. Female participants of child-bearing potential with negative serum pregnancy test at screening and negative urine pregnancy test at the time of screening.

6. Participants who are willing and able to comply with all study assessments and adhere to the protocol schedule.

Exclusion Criteria

1. Pregnant or lactating females or females of reproductive age not using a reliable form of contraception.

2. Subjects who take any medication likely to interfere with the study.

3. Subjects with a history of significant skin disease (e.g. eczema, psoriasis)

4. Subjects with an allergy likely to interfere with the study.

5. Subjects who are unwilling or unable to give written consent.

6. Patients involved in clinical trials and taken Investigational drugs within 30 days of enrolment.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analysis of reduction in the callus on the basis of assessment scale <br/ ><br>with detailed photographs having following Grades- <br/ ><br>➢ Grade 0: smooth, fine lines, and no dryness <br/ ><br>➢ Grade 1: dry lines, slight scaling, and skin thickening <br/ ><br>➢ Grade 2: small fissures, moderate scaling, and skin thickening <br/ ><br>➢ Grade 3: deep fissures, obvious scaling, and skin thickening <br/ ><br>➢ Grade 4: small gaps on fissures, severe scaling, and skin <br/ ><br>thickening. <br/ ><br>➢ Grade 5: Big gaps and Opening on Fissures, bleeding, extreme <br/ ><br>scaling and skin thickening. <br/ ><br>Improvement in Hydration based on ââ?¬Å?The Young Townson Foot <br/ ><br>skin hydration scaleââ?¬?. Graded as: <br/ ><br>Level 1: Well hydrated heels, with little or no signs of drying, <br/ ><br>Level 2: Drying skin but no callus, <br/ ><br>Level 3: Drying skin combined with callus, <br/ ><br>Level 4: Callused skin with open slits.Timepoint: day 0, 1st and 3rd

Secondary Outcome Measures

Name	Time	Method
Improvement in General skin condition, skin colour and cracks. <br/ ><br>Any discoloration or hyperpigmentation and change in cracks on <br/ ><br>Day 1 and Day3, when compared to day 0. <br/ ><br>ââ?¬Â¢ Perception of pain associated with crack and ulceration using a tenpoint scale in volunteers with grade 2-5 callus (Grading mentioned <br/ ><br>in Primary outcome first point). Pain Reduction from day 0 to day <br/ ><br>3 using the ââ?¬Å?Wong-Baker Facesââ??¢ Pain Rating Scaleââ?¬? (Annexure <br/ ><br>II). <br/ ><br>ââ?¬Â¢ Any adverse event during the study. <br/ ><br>ââ?¬Â¢ To evaluate experience of subjects by assessing questionnaire - <br/ ><br>SPQs (self-perception questionnaires) to be completed by each <br/ ><br>subject on Day 1 and Day 3. <br/ ><br>) Safety Endpoints <br/ ><br>ââ?¬Â¢ Adverse events (AEs) monitoring during the study period. <br/ ><br>ââ?¬Â¢ Skin irritation or tolerability assessment. (Annexure IV) <br/ ><br>ââ?¬Â¢ Physical examination & vital signsTimepoint: Day 1 and Day 3