| CTRI Number |
CTRI/2020/02/023537 [Registered on: 24/02/2020] Trial Registered Prospectively |
| Last Modified On: |
11/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic study] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To check the efficacy of Anti pollution products |
|
Scientific Title of Study
|
A DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE
EFFICACY AND TOLERABILITY OF ANTI-POLLUTION PRODUCT (S) ON FACIAL SKIN OF HEALTHY HUMAN SUBJECTS OVER A PERIOD OF TWO WEEKS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1920CICL135, Version 01 dated 28 Jan 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Soahum Bagchi |
| Designation |
PRINCIPAL INVESTIGATOR |
| Affiliation |
CIDP Biotech India Pvt. Ltd |
| Address |
CIDP Biotech India Pvt.Ltd,
32 B, First Floor, Rajinder Nagar,Pusa Road, New Delhi-110005 India
Central
DELHI
110005
India |
| Phone |
9999665384 |
| Fax |
|
| Email |
pi.in@cidp-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soahum Bagchi |
| Designation |
PRINCIPAL INVESTIGATOR |
| Affiliation |
CIDP Biotech India Pvt. Ltd |
| Address |
CIDP Biotech India Pvt.Ltd,
32 B, First Floor, Rajinder Nagar,Pusa Road, New Delhi-110005 India
Central
DELHI
110005
India |
| Phone |
9999665384 |
| Fax |
|
| Email |
pi.in@cidp-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajat Gupta |
| Designation |
Study Manager |
| Affiliation |
CIDP Biotech India Pvt. Ltd |
| Address |
CIDP Biotech India Pvt.Ltd,
32 B, First Floor, Rajinder Nagar,Pusa Road, New Delhi-110005 India
Central
DELHI
110005
India |
| Phone |
9910369168 |
| Fax |
|
| Email |
r.gupta@cidp-cro.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ITC Limited ITC Life Sciences Technology Centre |
| Address |
ITC Limited ITC Life Sciences & Technology Centre
No.3 1st Main Road Peenya Industrial Area, 1 Phase Bengaluru- 560058 India |
| Type of Sponsor |
Other [FMCG] |
|
|
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 Soahum Bagchi |
CIDP Biotech India Pvt Ltd |
32B First Floor Rajinder Nagar Pusa Road New Delhi
Central
DELHI |
9999665384
pi.in@cidp-cro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee-ACEAS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy male & female subjects of age group of 18 years to 50 years (both inclusive) will be selected |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
The product will be applied in a quantity of 0.5 grams (approximately 2 pumps) twice daily for a duration of 14 days |
| Intervention |
Two test Products |
Both the products (one product for one subject) will be applied in a quantity of 0.5 grams (approximately 2 pumps) twice daily for a duration of 14 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy male and female subjects aged 18-50 years old (both inclusive)
2. Occupationally be exposed to an excessively high concentration of air pollution (i.e.
outdoor workers)
3. Having sensitive skin or normal skin (as evaluated by stinging test)
4. Have lived in this high air pollution area for at least the past 2 years OR they must have
been occupationally exposed to this high air pollution for the past 2 years
5. Not be using fairness or antiaging or sunscreen creams/lotions
6. Free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face
7. Agree not to use any other product/treatment (eg: night cream) on their face during the
study period (for male subjects shaving cream/foam/gel can be used for shaving purpose)
8. Agree not to carry out bleaching or any other procedures including facial etc. on face
during the study period
9. Agree to remove all jewellery on/around face (e.g., necklace, earrings, nose ring) during
VISIA imaging
10. Female subjects with child-bearing potential willing to undergo Urine Pregnancy Test on baseline visit and to use acceptable methods of contraception
11. Subject willing to provide written informed consent and is able to read, speak, write, and
understand English or Hindi
12. Ready to follow instructions and study restrictions during the study period |
|
| ExclusionCriteria |
| Details |
1. Known hypersensitivity to any of the study products or constituents
2. Any significant skin pathology in the test area
3. Currently taking any medication including food supplements, which the Investigator
believes may influence the interpretation of the data
4. Having chronic illness or had major surgery in the last year
5. Undergoing any treatment of any skin condition on their face/body
6. Allergic or sensitive to bar cleansing products, creams/lotions, artificial jewellery or anything else
7. Females in pregnancy (self-declared on screening visit and confirmed by UPT on baseline visit) or lactation at the beginning of the study or planned during the study
8. Participation in any other clinical trial up to 1 month prior to inclusion and during the
study
9. Any topical or systemic treatment(s) such as NSAIDs, corticosteroids, retinoids, vitamins
etc. that, in the investigator’s judgement, could interfere with the study treatments /
assessments, taken 2 weeks prior to inclusion and / or planned during the study
10. Who have started, stopped or changed their hormonal treatment(s) (including contraceptive pill) in the previous one month prior to the study
11. Any history of allergy to NSAIDs, vitiligo, herpes, local infection & epilepsy |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of two topical test products in comparison with placebo on pollution-induced skin damages used over a period of 2 weeks, based on clinical, instrumental and subjective evaluations done at predetermined time points |
All the examination will be done Day 0, Day 7 and Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="264"
Sample Size from India="264"
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)
|
26/02/2020 |
| 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="14" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Objective:- To assess the efficacy of two topical test products in comparison with placebo on pollution-induced skin damages used over a period of 2 weeks, based on clinical, instrumental and subjective evaluations done at predetermined time points
Sample Size:- Sufficient number of healthy male and female subjects of age 18-50 years (both inclusive) will be screened to include 264 subjects (preferably in equal ratio of male and female and equal ratio of sensitive and normal skin type) divided in three equal group so that 240 subjects (80 subjects in each group) are expected to complete the study
The study could not be completed due to COVID 19 pandemic |