| CTRI Number |
CTRI/2025/04/086008 [Registered on: 30/04/2025] 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 of CITTA Multiple Personal Care Products |
|
Scientific Title of Study
|
A Clincial Study to Evaluate the Skin Irritation Potential of CITTA Multiple Personal Care Products on Healthy Human Volunteers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT595 Version 1.0 dated 11 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 |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250002
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
|
| CCFT Laboratories, 135, Punjabipura, Delhi Road, Meerut, India |
| Synergy System, Plot no A-17,Jay Ashpura, Vasai Road East,Palghar-401209 |
|
|
Primary Sponsor
|
| Name |
Synergy System |
| Address |
Plot no A-17,Jay Ashpura, Vasai Road East,Palghar-401209 |
| 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 |
| Intervention |
Finn Chamber |
Each patch contains 40 microgram of 1.CITTA Vitamin C Brightening Face Serum, 2.CITTA Cica Gentle Face Scrub, 3.CITTA Regenerative Face Serum, 4.CITTA Radiance Serum with Gold,5.CITTA Aqua Boost Face Gel, 6.CITTA Supercharged Hair Oil-200/50ml, 7.CITTA Strawberry Body Cream,8.CITTA Strawberry Creamy Body Scrub, 9.CITTA Anti-Dandruff Shampoo, 10.CITTA Deep Conditioning Hair Mask, 11.CITTA Regenerative Night Cream, 12. CITTA Cica Gentle Face Cleanser, 13.CITTA Vit C Brightening Face Scrub, 14.CITTA Brightening Face Cleanser, 15.CITTA Encapsulated Ubtan Face Wash, 16.CITTA Hair Growth Serum, 17.CITTA Invisible Sunscreen Serum SPF 50 PA++++, 18.CITTA Refreshing Body Cleanser, 19.CITTA Nourishing Body Cleanser, 19.CITTA Ceramides & White Tea Face Moisturiser, 20.CITTA Super Light Anti-Frizz Hair Serum, 21.CITTA Arabica Coffee Body Cream, 22.CITTA Coffee Creamy Body Scrub, 23.CITTA Beetroot Lip Balm, 24.CITTA Lip Glow Masque, 25.CITTA Soothing Body Milk - 200ml/50ml, 26.CITTA Stretch Mark Cream, 27.CITTA Depigmentation Body Cream, 28.CITTA Soothing Sunscreen SPF 50 PA+++, 29. Negative control(0.9% NaCl,30.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. 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 |
Day0 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)
|
10/05/2025 |
| 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 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
|
The below products would be tested as per the guideline IS4011 for dermal safety assessment.
1.CITTA Vitamin C Brightening Face Serum 2.CITTA Cica Gentle Face Scrub 3.CITTA Regenerative Face Serum 4.CITTA Radiance Serum with Gold 5.CITTA Aqua Boost Face Gel 6.CITTA Supercharged Hair Oil-200/50ml 7.CITTA Strawberry Body Cream 8.CITTA Strawberry Creamy Body Scrub 9.CITTA Anti-Dandruff Shampoo 10.CITTA Deep Conditioning Hair Mask 11.CITTA Regenerative Night Cream 12. CITTA Cica Gentle Face Cleanser 13.CITTA Vit C Brightening Face Scrub 14.CITTA Brightening Face Cleanser 15.CITTA Encapsulated Ubtan Face Wash 16.CITTA Hair Growth Serum 17.CITTA Invisible Sunscreen Serum SPF 50 PA++++ 18.CITTA Refreshing Body Cleanser 19.CITTA Nourishing Body Cleanser 20.CITTA Ceramides & White Tea Face Moisturiser 21.CITTA Super Light Anti-Frizz Hair Serum 22.CITTA Arabica Coffee Body Cream 23.CITTA Coffee Creamy Body Scrub 24.CITTA Beetroot Lip Balm 25.CITTA Lip Glow Masque 26.CITTA Soothing Body Milk - 200ml/50ml 27.CITTA Stretch Mark Cream 28.CITTA Depigmentation Body Crea 29.CITTA Soothing Sunscreen SPF 50 PA+++
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.
|