| CTRI Number |
CTRI/2025/08/092966 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| 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 test Skin MTX Multiple Personal care products |
|
Scientific Title of Study
|
A Clinical Study to evaluate the skin Irritation potential Skin MTX Multiple Personal care products on healthy human volunteers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT766 Version 1.0 dated 01 Aug 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 |
Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
09027285265 |
| Fax |
|
| Email |
robinderm25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
UTTAR PRADESH
250005
India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
08937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
UTTAR PRADESH
250005
India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
08937015757 |
| 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 |
| Celblos Dermal Research Centre Ptd. Ltd, 237 Pandan Loop, Westech Building #05-03 Singapore 128424 |
|
|
Primary Sponsor
|
| Name |
Celblos Dermal Research Centre Ptd. Ltd |
| Address |
237 Pandan Loop, Westech Building #05-03 Singapore 128424 |
| 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 |
09027285265
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/ microliter of 1.SkinMTX 1% Ceramide Capsule, 2.SkinMTX Hydra-Firm PDRN Collagen Mask, 3.SkinMTX Telomatrix Professional Exfoliance Peel, 4.SkinMTX Telomatrix Professional Gold Tensing Mask + Gold Tensing Mask Activator ,5.SkinMTX Telomatrix Professional Green Caviar Massage Cream, 6.SkinMTX Telomatrix Professional Liftonix Essence ,7.SkinMTX Hyalu-Collagen Professional Treatment Lactic Acid Soft Peel ,8.SkinMTX Hyalu-Collagen Professional Treatment Collagen HA Booster, 9.SkinMTX Hyalu-Collagen Professional Treatment HA Velvet Mousse, 10.SkinMTX Hyalu-Collagen Professional Treatment Organic Jojoba Oil, 11.SkinMTX Hyalu-Collagen Professional Treatment Hydrolyzed Collagen Concentrate, 12. SkinMTX MediFix Peel System DermSmart Peel Resurfacer, 13. SkinMTX MediFix Peel System HA-Peptide Essence, 14. SkinMTX MediFix Peel System UltraMoist Lotion,15. SkinMTX RadicalWhite Clarity Professional Resurfacing Peel, 16. SkinMTX RadicalWhite Clarity Professional Meta-C Complex + Meta-C Powder, 17. SkinMTX RadicalWhite Clarity Professional Hydro-Max Gel Essence, 18. SkinMTX RadicalWhite Clarity Professional Intense Fusion Mask 1, 19. SkinMTX RadicalWhite Clarity Professional Booster White Mask 2, 20. SkinMTX PuriSmart Professional ClariSoft Exfoliant Cream, 21. SkinMTX PuriSmart Professional BioFresh Pore Refiner, 22. SkinMTX PuriSmart Professional Purifique Mineral Mask, 23. SkinMTX PuriSmart Professional PhytoMoist Gel, 24. Negative control(0.9% NaCl, 25.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. 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)= "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)
|
22/08/2025 |
| 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="15" |
|
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
|
The below products would be tested as per the guideline ISO10993 part 23 for dermal safety assessment.
1.SkinMTX 1% Ceramide Capsule 2.SkinMTX Hydra-Firm PDRN Collagen Mask 3.SkinMTX Telomatrix Professional Exfoliance Peel 4.SkinMTX Telomatrix Professional Gold Tensing Mask + Gold Tensing Mask Activator 5.SkinMTX Telomatrix Professional Green Caviar Massage Cream 6.SkinMTX Telomatrix Professional Liftonix Essence 7.SkinMTX Hyalu-Collagen Professional Treatment Lactic Acid Soft Peel 8.SkinMTX Hyalu-Collagen Professional Treatment Collagen HA Booster 9.SkinMTX Hyalu-Collagen Professional Treatment HA Velvet Mousse 10.SkinMTX Hyalu-Collagen Professional Treatment Organic Jojoba Oil 11.SkinMTX Hyalu-Collagen Professional Treatment Hydrolyzed Collagen Concentrate 12. SkinMTX MediFix Peel System DermSmart Peel Resurfacer 13. SkinMTX MediFix Peel System HA-Peptide Essence 14. SkinMTX MediFix Peel System UltraMoist Lotion 15. SkinMTX RadicalWhite Clarity Professional Resurfacing Peel 16. SkinMTX RadicalWhite Clarity Professional Meta-C Complex + Meta-C Powder 17. SkinMTX RadicalWhite Clarity Professional Hydro-Max Gel Essence 18. SkinMTX RadicalWhite Clarity Professional Intense Fusion Mask 1 19. SkinMTX RadicalWhite Clarity Professional Booster White Mask 2 20. SkinMTX PuriSmart Professional ClariSoft Exfoliant Cream 21. SkinMTX PuriSmart Professional BioFresh Pore Refiner 22. SkinMTX PuriSmart Professional Purifique Mineral Mask 23. SkinMTX PuriSmart Professional PhytoMoist Gel
The product will be tested for skin irritation on 30 human volunteers. Assessment would be done on day 0, day 2, with followup visit on day 8 for erythema and Oedema scoring |