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

Not yet recruiting

Brief Summary: 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

Recruitment & Eligibility

Inclusion Criteria

Diabetic patients with dry and callused skin (Grading â€“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.

Exclusion Criteria

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) 4.
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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Improvement in General skin condition, skin colour and cracks.	Any discoloration or hyperpigmentation and change in cracks on

Locations (1): Aashrya Eye, Skin and Dental Clinic
🇮🇳
West, DELHI, India
Aashrya Eye, Skin and Dental Clinic
🇮🇳West, DELHI, India
Dr Anjeeta Dhawan
Principal investigator
9810631823
anjeetadr@gmail.com