| CTRI Number |
CTRI/2024/08/072157 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate efficacy and safety of Anti-pollution product. |
|
Scientific Title of Study
|
A clinical study to evaluate the protective effect of the test product against environmental pollution on the skin along with its safety on healthy adult female subjects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B04499; Version: 01, Dated 18 Jul 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhagirath Patel |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department, Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825618138 |
| Fax |
|
| Email |
bpatel3@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Simran Sethi |
| Designation |
Director-Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department, Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
|
| Email |
ssethi@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parth Joshi |
| Designation |
Overall Study Coordinator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department, Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
|
| Email |
pjoshi@cliantha.com |
|
|
Source of Monetary or Material Support
|
| Cliantha Research, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054, Gujarat, India. |
| Zydus Wellness Products Limited, Plot No 115/5 TP Scheme No 51, Beside Bliss Apartment, Opp Viola Apartment, Ambli Bopal Road, Ahmedabad 380015. |
|
|
Primary Sponsor
|
| Name |
Zydus Wellness Products Limited |
| Address |
Plot No 115/5 TP Scheme No 51, Beside Bliss Apartment, Opp Viola Apartment, Ambli Bopal Road, Ahmedabad 380015 |
| Type of Sponsor |
Other [Health and Hygiene] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhagirath Patel |
Cliantha Research |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off Sindhubhavan Road,
Nr. Mann Party Plot Cross Road,
Bodakdev, Ahmedabad-380054, Gujarat
Ahmadabad
GUJARAT |
9825618138
bpatel3@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy female subjects of age group of 18 years to 45 years (both inclusive). |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Face Wash |
Approx. 1 – 1.5 gm of product will be applied twice a day |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1) Subjects who have lived in high air pollution areas for at least the past 5 years / have been occupationally exposed to high air pollution for the past 2 years.
2) Subjects with visible blackheads on the face.
3) Subjects with at least 2 blemishes, uneven skin tone and visible redness on face.
4) Subjects willing to provide written informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1) Subjects using any other face wash during the study period.
2) Subjects who are receiving topical or systemic treatments for pigmentation within the last 30 days.
3) Subjects having any active dermatological skin diseases (e.g., psoriasis, atopic dermatitis, rosacea etc.), that might interfere with clinical assessments.
4) Subjects participating in other similar cosmetic or therapeutic study within last four weeks. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of test product on pollution-induced skin damages, based on clinical, instrumental and subjective evaluations done at predetermined time points. |
Day 01, Day 07, Day 14, Day 21 and Day 28. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/08/2024 |
| Date of Study Completion (India) |
01/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
|
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
|
This is an
open label, non-randomized, single-centre, single arm clinical study to
evaluate the protective effect of the test product against environmental
pollution on the skin along with its safety on healthy adult female subjects.
The potential
subjects will be screened as per the inclusion and exclusion criteria only
after obtaining written informed consent from the subjects.
All eligible
subjects will undergo clinical evaluation by a Dermatologist, instrument
evaluation and subjective evaluation. Safety will be assessed throughout the study by
monitoring adverse events. |