| CTRI Number |
CTRI/2022/09/045825 [Registered on: 23/09/2022] Trial Registered Prospectively |
| Last Modified On: |
22/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Pilot Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of Dermatonics Heel Balm compared to Moisturex cream for the Reduction/Removal of Hard Callused Plantar skin |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CE-DER-2022-01 Ver 1.0 dated 04 Jul 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjeeta Dhawan |
| Designation |
Sr. Consultant |
| Affiliation |
Aashrya Eye, Skin and Dental Clinic |
| Address |
Aashrya Eye, Skin and Dental Clinic
Dermatology Division, Dermatology Department, Room no. - 2, A-52, Block A, Meera Bagh, Paschim Vihar
West
DELHI
110087
India |
| Phone |
9810631823 |
| Fax |
|
| Email |
anjeetadr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arun Semwal |
| Designation |
Project Manager |
| Affiliation |
CliniExperts Services Pvt. Ltd. |
| Address |
CliniExperts Services Pvt. Ltd.
Unit No. 325, City Centre Mall, Plot No. 5, Sector 12, Dwarka
Unit No. 325, City Centre Mall, Plot No. 5, Sector 12, Dwarka, New Delhi – 110075
West
DELHI
110075
India |
| Phone |
9555564408 |
| Fax |
|
| Email |
arun.chandra@cliniexpertsresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Arun Semwal |
| Designation |
Project Manager |
| Affiliation |
CliniExperts Services Pvt. Ltd. |
| Address |
CliniExperts Services Pvt. Ltd.
Unit No. 325, City Centre Mall, Plot No. 5, Sector 12, Dwarka
Unit No. 325, City Centre Mall, Plot No. 5, Sector 12, Dwarka
West
DELHI
110075
India |
| Phone |
9555564408 |
| Fax |
|
| Email |
arun.chandra@cliniexpertsresearch.com |
|
|
Source of Monetary or Material Support
|
| Cliniexperts Research Private Limited
Unit No. 325-326, City Centre Mall, Plot No. 5, Sector 12, Dwarka, New Delhi-110075, India |
|
|
Primary Sponsor
|
| Name |
Dr Anjeeta Dhawan |
| Address |
Aashrya Eye, Skin and Dental Clinic, Dermatology Division, Dermatology Department, Room no. - 2, A-52, Block A, Meera Bagh, Paschim Vihar, New Delhi-110087 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anjeeta Dhawan |
Aashrya Eye, Skin and Dental Clinic |
Aashrya Eye, Skin and Dental Clinic, Dermatology Division, Dermatology Department, Room no. - 2, A-52, Block A, Meera Bagh, Paschim Vihar
West
DELHI |
9810631823
anjeetadr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Good Society for ethical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L84||Corns and callosities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 Left Foot |
| Comparator Agent |
Moisturex |
Dose-1cm of Moisturex 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 Right Foot |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Diabetic patients with dry and callused skin (Grading –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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 “The Young Townson Foot
skin hydration scaleâ€. 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. |
day 0, 1st and 3rd |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
• 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 “Wong-Baker Faces™ Pain Rating Scale†(Annexure
II).
• Any adverse event during the study.
• 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
• Adverse events (AEs) monitoring during the study period.
• Skin irritation or tolerability assessment. (Annexure IV)
• Physical examination & vital signs |
Day 1 and Day 3 |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/09/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |