| CTRI Number |
CTRI/2025/05/087811 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
17/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
skin saftey of Reginald Men Lip Balm |
|
Scientific Title of Study
|
A Clinical study to Skin Irritation Potential of Reginald Men Lip Balm on Healthy Human Volunteers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT626 Version 1.0 dated 18 Apr 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
UTTAR PRADESH
250005
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| BTM Ventures Pvt. Ltd.,4 Floor, Lakshmi prasad ashrayam, Plot no. 194, Road no. 38, Ayyappa society, Madhapur, Hyderabad, Telangana 500081 |
| CCFT Laboratories, 135, Punjabipura, Delhi Road, Meerut, India 250002 |
|
|
Primary Sponsor
|
| Name |
BTM Ventures Pvt. Ltd. |
| Address |
4 Floor, Lakshmi prasad ashrayam, Plot no. 194, Road no. 38, Ayyappa society, Madhapur, Hyderabad, Telangana 500081 |
| 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 |
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 |
| Intervention |
Finn Chamber |
Each Patch contain 0.04 ml (40 microliters) of test sample, 1. Reginald Men Lip Balm, 2.Negative contol (0.9% NaCl, 3.Positive Control- 1% SLS) Route of Administration: Topical Frequency: Once Duration:24hrs. as per ISO 10993 Part23 |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Voluntary man or women between 18 and 65 years.
2. Phototype III to V.
3. Having apparently healthy skin on test area.
4. For whom the investigator considers that the compliance will be correct.
5. Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures.
6. Having signed a Consent Form.
7. Willingness to avoid intense UV exposure on test site (sun or artificial UV) during the course of the study.
8. Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise, sauna), during the
course of the study.
9. Should be able to read and write (in English, Hindi or local language).
10. Having valid proof of identity and age |
|
| ExclusionCriteria |
| Details |
1. Pregnant or nursing mothers
2.Scars, excessive terminal hair or tattoo on the studied area
3.Henna tattoo anywhere on the body (in case of studies involving hair dyes)
4.Dermatological infection or pathology on the level of studied area
5.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye)
6.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
7.Chronic illness which may influence the outcome of the study.
8.Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month)
9.Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Skin Irritation Score-erythema & oedema |
Day 0, Day 2 and Day 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/05/2025 |
| 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="0"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The below products would be tested as per the guideline ISO 10993 Part23 for dermal safety assessment.
1. Reginald men Lip Balm
The product will be tested for skin irritation on 30 human volunteers. Assessment would be done on day 0, day 3, with followup visit on day 8 for erythema and Oedema scoring |