Health Condition 1: L84- Corns and callosities
Conditions
Interventions
Intervention1: Dermatonics Heel Balm: Dose- 1cm of Dermatonics Heel Balm is to be applied on affected area.
Frequency- Twice a day(12 hours apart)
Total Duration- 3 days in total
and is to applied on
Sponsors
Dr Anjeeta Dhawan
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analysis of reduction in the callus on the basis of assessment scale with detailed photographs having following Grades- ➢ Grade 0: smooth, fine lines, and no dryness ➢ Grade 1: dry lines, slight scaling, and skin thickening ➢ Grade 2: small fissures, moderate scaling, and skin thickening ➢ Grade 3: deep fissures, obvious scaling, and skin thickening ➢ Grade 4: small gaps on fissures, severe scaling, and skin thickening. ➢ Grade 5: Big gaps and Opening on Fissures, bleeding, extreme scaling and skin thickening. Improvement in Hydration based on ââ?¬Å?The Young Townson Foot skin hydration scaleââ?¬?. Graded as: Level 1: Well hydrated heels, with little or no signs of drying, Level 2: Drying skin but no callus, Level 3: Drying skin combined with callus, Level 4: Callused skin with open slits.Timepoint: day 0, 1st and 3rd | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in General skin condition, skin colour and cracks. Any discoloration or hyperpigmentation and change in cracks on Day 1 and Day3, when compared to day 0. ââ?¬Â¢ Perception of pain associated with crack and ulceration using a tenpoint scale in volunteers with grade 2-5 callus (Grading mentioned in Primary outcome first point). Pain Reduction from day 0 to day 3 using the ââ?¬Å?Wong-Baker Facesââ??¢ Pain Rating Scaleââ?¬? (Annexure II). ââ?¬Â¢ Any adverse event during the study. ââ?¬Â¢ To evaluate experience of subjects by assessing questionnaire - SPQs (self-perception questionnaires) to be completed by each subject on Day 1 and Day 3. ) Safety Endpoints ââ?¬Â¢ Adverse events (AEs) monitoring during the study period. ââ?¬Â¢ Skin irritation or tolerability assessment. (Annexure IV) ââ?¬Â¢ Physical examination & vital signsTimepoint: Day 1 and Day 3 | — |
Countries
India
Contacts
Public ContactArun Semwal
CliniExperts Services Pvt. Ltd.
Outcome results
None listed