| CTRI Number |
CTRI/2024/11/077114 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Skin Safety of a Nano Urea emulsion Through 24-Hour Patch Testing in Healthy Individuals. |
|
Scientific Title of Study
|
Evaluation of Dermatological Safety of an Investigational Urea Nano-Emulsion Product Through a 24-Hour Occlusive Patch Test on Healthy Human Subjects. |
| Trial Acronym |
CROM/11 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijaykumar Patil |
| Designation |
Medical Superitendent |
| Affiliation |
Prakash Institute of Medical Science and Research |
| Address |
PSM Department, Room no. 7, Islampur Sangli road, Islampur, Walwa, Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9371877555 |
| Fax |
|
| Email |
cromgoa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhananjay Lad |
| Designation |
Director |
| Affiliation |
CROM Nano Technologies Pvt Ltd |
| Address |
CROM Premises, Research Department, Waterfront Building, Office F1 to F7, Opp Shalini palace, Ranaka lake, Kolhapur
Kolhapur
MAHARASHTRA
416001
India |
| Phone |
9158592177 |
| Fax |
|
| Email |
cromnanotechnologies@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhananjay Lad |
| Designation |
Director |
| Affiliation |
CROM Nano Technologies Pvt Ltd |
| Address |
CROM Premises, Research Department, Waterfront Building, Office F1 to F7, Opp Shalini palace, Ranaka lake, Kolhapur
Kolhapur
MAHARASHTRA
416001
India |
| Phone |
9158592177 |
| Fax |
|
| Email |
cromnanotechnologies@gmail.com |
|
|
Source of Monetary or Material Support
|
| CROM Clinical Research and Medical Tourism Pvt. Ltd. Division Nano Agro Technologies, Goa, India, Pin 403001. |
|
|
Primary Sponsor
|
| Name |
CROM Clinical Research and Medical Tourism Pvt. Ltd. Division Nano Agro Technologies |
| Address |
In front of AYUSH cell, MOPA International Airport Flyover Junction, NH-17, Goa-Mumbai Highway, Dhargal, Oshalbag, Goa 403513 |
| Type of Sponsor |
Research institution |
|
|
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 Vijaykumar Patil |
Prakash Institute of Medical Science and Research |
PSM Department, Room no. 7, Islampur Sangli road, Islampur, Walwa, Sangli
Sangli
MAHARASHTRA
415409
India
Sangli
MAHARASHTRA |
9371877555
cromgoa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Prakash Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Male |
| Details |
Subjects in age group 18 - 55 years (both the ages inclusive).
Healthy male subjects.
Subjects with Fitzpatrick skin type III to V.
Subjects willing to give a written informed consent.
Subjects willing to maintain the patch test in position for 24 hours.
Subject having not participated in a similar investigation in the past one month.
Subjects willing to come for regular follow up visits.
Subjects ready to follow instructions during the study period.
|
|
| ExclusionCriteria |
| Details |
Infection, allergy on the tested area.
Skin allergy, antecedents or atopic subjects.
Athletes and subjects with history of excessive sweating.
Cutaneous disease which may influence the study result.
Subjects on oral corticosteroid .
Subjects participating in any other cosmetic or therapeutic study.
Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety on dermal patch tests for all the products |
0 hrs, 24 hrs and and 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/11/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="9" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Total number of subjects: 60 healthy human subjects Gender: Male and Female Age group: 18-60 years Test site: At the nape of the neck, in between two shoulder blades in males. Forearm in women Test period: 9 days for all subjects including screening and enrollment period. Patch test unit: Derma proof Aluminium Finn chamber prefixed to a scanpore tap |