| CTRI Number |
CTRI/2025/08/093500 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety and Efficacy of Be Bodywise 30 percent Urea Feet Roll On on Crack Heel |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Safety and Efficacy of Be Bodywise 30% Urea Foot Roll On on Crack Heel Volunteers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT740 Version 1.0 dated 18 Jul 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Robin Chugh |
| Designation |
Principal Investigator |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9027285265 |
| Fax |
|
| Email |
robinderm25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road, Meerut, UTTAR PRADESH-250005 |
| Mosaic Wellness Pvt. Ltd, 6th Floor, ThaneOne West - 400610 |
|
|
Primary Sponsor
|
| Name |
Mosaic Wellness Pvt. Ltd |
| Address |
6th Floor, ThaneOne West – 400610 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Robin Chugh |
CCFT laboratories |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH |
9027285265
robinderm25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ARMHRC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Test Product: Be Bodywise 30% Urea Foot Roll on |
Gently use the Test Product over the foot twice a day.
Application: twice a day, Route of administration: Topical, Duration: 2 week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Gender: Male or Female with age 18-45
2. Subjects with cracked heel
3. Subjects willing to give written informed consent
4. Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
5. Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
6. Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.
|
|
| ExclusionCriteria |
| Details |
1. Subjects who are pregnant, breast-feeding, or planning to become pregnant during the study.
2. Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
3. Have open sores or open lesions in the treatment area(s).
4. Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of the product.
5. Subjects who are pregnant, breast-feeding, or planning to become pregnant during the study.
6. Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
7. Have open sores or open lesions in the treatment area(s).
8. Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of the product.
9. Have participated in any interventional clinical trial in the previous 90 days.
10. Have a known sensitivity to any of the constituents of the test product including sensitivities to
11. Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including corticosteroids.
12. Have not skin related issues
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in Skin Hydration
2. Change in Craked Heels
3. Change in Skin Smoothness
4. Change in Skin Softness |
At T0min, T+1hrs, T+7days, T+14days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. SGA |
At T14days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
03/09/2025 |
| 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="0"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Test Product: 1. Be Bodywise 30% Urea Foot Roll On
Dose: Gently massage approx. over cracked heels , Route of Administration: Topical Duration: 14days
Time Points: At T0min, T+1hrs, T+7days, T+14days
Assessments:
1. Change in Skin hydration- By Corneometer 2. Change in Cracked heels 3. Change in Skin Smoothness 4. Change in Skin Softness
|