| CTRI Number |
CTRI/2024/07/071534 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess the Brightening Potential of The Derma Co 15percent Vitamin C Intense Brightening Ampoule Kit |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Brightening Potential of The Derma Co 15 percent Vitamin C Intense Brightening Ampoule Kit on Healthy Human Subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT249 Version 1.0 Dated 30 June 2023 |
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 250002 |
| Honasa Consumer Limited , 10th & 11th Floor, Capital Cyberscape, Sector 59, Gurugram, Haryana 122101 |
|
|
Primary Sponsor
|
| Name |
Honasa Consumer Limited |
| Address |
10th & 11th Floor, Capital Cyberscape, Sector 59, Gurugram, Haryana 122101 |
| 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 |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Test Product-The Derma Co 15% Vitamin C Intense Brightening Ampoule Kit |
Dose: Apply whole ampule drop wise in outward direction. Duration- once (1 day), Route of administration- Topical |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Gender: Male or Female with age 18-45, with male:female (80:20) ratio with normal , oily (avoid acne and too much oily skin) and combination skin. 3 to 4 candidates with Sensitive skin.
2. Subjects willing to give written informed consent
3. Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
4. Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
5. Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.
6. Should be able to read and write (in English, Hindi or local language).
7. 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.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye)
4.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures
5.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)
6.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 |
1. Change in Lightness
2. Change in melanin
3. Gloss by glossymeter |
At 0, 30 min, 7days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
10/08/2024 |
| 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="7" |
|
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
|
Single-arm clinical study to evaluate the Brightening Potential
of The Derma Co 15% Vitamin C Intense Brightening
Ampoule Kit 1. The Derma Co 15% Vitamin C Intense Brightening
Ampoule Kit The products will be tested on 32 human volunteers. Assessment would Notice the improvement in Skin brightening, Melanin content, and skin Lightness with follow-up visits on Day 0, and Day 7.
The study is done as per BIS standard 4011 |
|