| CTRI Number |
CTRI/2024/09/074498 [Registered on: 27/09/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Skin Irritation of Netsurf Personal Care Products |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Skin Irritation Potential of Netsurf Personal Care Products on Healthy Human Subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT 342 Version 1.0 dated 11 Sep 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Robin Chugh |
| Designation |
Principal Investigator |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250002
India |
| Phone |
7078103723 |
| Fax |
|
| Email |
robinderm25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250002
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 |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| CCFT Laboratories, 135, Punjabipura, Delhi Road, Meerut, India |
| Netsurf Communication Pvt.Ltd, Survey No. 107, Plot No. 2, Baner Rd, Laxman Nagar, Baner, Pune, Maharashtra 411045 |
|
|
Primary Sponsor
|
| Name |
Netsurf Communication Pvt.Ltd |
| Address |
Survey No. 107, Plot No. 2, Baner Rd, Laxman Nagar, Baner, Pune, Maharashtra 411045 |
| 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 |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH |
7078103723
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 contains 40 microgram of 1 H&M Scalp Renaissance Anti -Dandruff Shampoo, 2.H&M Scalp Renaissance Anti-Hair Fall Shampoo, 3.H&M Scalp Renaissance Hydraboost Conditioner, 4.H&M Scalp Renaissance Anti -Dandruff Serum, 5.H&M Scalp Renaissance Hair Nutriment, 6.H&M Herbal Dental Paste, 7.H&M Anti- Pollution Face Wash, 8. H&M Oil Control Face Wash, 9.H&M Brightening Face Wash, 10.H&M Hydraboost Foaming Cleanaser, 11.H&M Moisturising Day Cream, 12.H&M Under Eye Rejuvenating Gel, 13.H&M Anti-Acne Gel, 14.H&M Sunscreen SPF-30 PA+++ Cream, 15.H&M Mositurising Body Lotion, 16.H&M Neem Turmeric Anti-Septic Cream, 17.H&M Aloe Turmeric Anti-Septic Cream, 18.H&M Crackz Cream, 19.H&M Spot Eraser Anti-Pigmentation Cream, 20.H&M Mositurising Soap, 21.H&M Muscular Pain Cream, 22. Negative control(0.9% NaCl, 23.Positive Control- 1% SLS) Route of Administration: Topical Frequency: Once Duration:24hrs |
| 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. Photo type 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. Should be able to read and write (in English, Hindi or local language).
8. 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 and Day 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/10/2024 |
| 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="0"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
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 IS4011 for dermal safety assessment.
1 H&M Scalp Renaissance Anti -Dandruff Shampoo2.H&M Scalp Renaissance Anti-Hair Fall Shampoo 3.H&M Scalp Renaissance Hydraboost Conditioner 4.H&M Scalp Renaissance Anti -Dandruff Serum 5.H&M Scalp Renaissance Hair Nutriment 6.H&M Herbal Dental Paste 7.H&M Anti- Pollution Face Wash 8. H&M Oil Control Face Wash 9.H&M Brightening Face Wash 10.H&M Hydraboost Foaming Cleanaser 11.H&M Moisturising Day Cream 12.H&M Under Eye Rejuvenating Gel 13.H&M Anti-Acne Gel 14.H&M Sunscreen SPF-30 PA+++ Cream 15.H&M Mositurising Body Lotion 16.H&M Neem Turmeric Anti-Septic Cream 17.H&M Aloe Turmeric Anti-Septic Cream 18.H&M Crackz Cream 19.H&M Spot Eraser Anti-Pigmentation Cream 20.H&M Mositurising Soap 21.H&M Muscular Pain Cream The product will be tested for skin irritation on 24 human volunteers. Assessment would be done on day 0, day 1, with followup visit on day 8 for erythema and Oedema scoring.
|