| CTRI Number |
CTRI/2021/02/031335 [Registered on: 16/02/2021] Trial Registered Prospectively |
| Last Modified On: |
16/03/2022 |
| 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 cosmetic products in offering protection against skin stress inducers including pollution |
|
Scientific Title of Study
|
A double blind, randomized, parallel group study to evaluate the efficacy of anti-pollution product (s) on facial skin on healthy human subjects over a period of two weeks |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1920CICL135 Version 02 dated 18 Jan 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Annie Jain |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt. Ltd |
| Address |
32-B, First Floor, Pusa Road, Rajinder Nagar, New Delhi-110005, India
Not Applicable
Central
DELHI
110005
India |
| Phone |
09582645711 |
| Fax |
|
| Email |
a.jain@cidp-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Annie Jain |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt. Ltd |
| Address |
32-B, First Floor, Pusa Road, Rajinder Nagar, New Delhi-110005, India
Not Applicable
DELHI
110005
India |
| Phone |
09582645711 |
| Fax |
|
| Email |
a.jain@cidp-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Deepika Arora |
| Designation |
Study Manager |
| Affiliation |
CIDP Biotech India Pvt. Ltd |
| Address |
32-B, First Floor, Pusa Road, Rajinder Nagar, New Delhi-110005, India
Not Applicable
Central
DELHI
110005
India |
| Phone |
08178206475 |
| Fax |
|
| Email |
d.arora@cidp-cro.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ITC Limited ITC Life Sciences Technology Center |
| Address |
ITC Limited ITC Life Sciences Technology Center
No. 31st Main Road Peenya Industrial Area, 1 Bengaluru-560058, India |
| Type of Sponsor |
Other [FMGC] |
|
|
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 Annie Jain |
CIDP Biotech India Pvt. Ltd |
32B, First Floor, Pusa Road, Rajinder Nagar, New Delhi-11005
Central
DELHI |
09582645711
a.jain@cidp-cro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy male and female volunteers of age group 18 to 50 years (both inclusive) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
One test product (Product 1: ITC-B or Product 2: ITC- C) |
Cosmetic formulation for external application on skin (face). Each subject will apply three pumps topically(approximately 0.50 gms) of test product twice daily at
home (morning and evening), for 2 weeks (except on visit days when morning application will be done at the centre) |
| Comparator Agent |
Placebo (Product 1: ITC-B or Product 2: ITC- C) |
Cosmetic formulation for external application on skin (face). Each subject will apply three pumps topically(approximately 0.50 gms) of test product twice daily at home (morning and evening), for 2 weeks (except on visit days when morning application will be done at the centre) |
|
|
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 (both inclusive)
2.Having exposure of about 3-4 hrs daily to Blue light, hot air, smoke, extreme temperatures encountered indoors
3.Having sensitive skin or non-sensitive skin (as evaluated by stinging test)
4.Having skin sensitivity to environmental pollutants / Blue Light / Heat / extreme temperatures manifested as visible skin changes such as Pruritus, Erythema, Flaking, Stinging (this is applicable for subjects of sensitive skin only)
5.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
6.Not be using fairness or anti-aging or sunscreen creams/lotions
7.Free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face
8.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)
9.Agree not to carry out bleaching or any other procedures including facial etc. on face during the study period
10.Agree to remove all jewellery on/around face (e.g., necklace, earrings, nose ring) during VISIA imaging
11.Female subjects with child-bearing potential willing to undergo Urine Pregnancy Test on baseline visit and to use acceptable methods of contraception
12.Subject willing to provide written informed consent and is able to read, speak, write, and understand English or Hindi
13.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 on
pollution-induced skin damages used over a
period of 2 weeks, based on clinical,
instrumental and subjective evaluations done at
predetermined time points |
To assess the efficacy of two topical test
products on pollution-induced skin damages used over a
period of 2 weeks, based on clinical,
instrumental and subjective evaluations done at
predetermined time points |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="98" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/02/2021 |
| Date of Study Completion (India) |
15/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="14" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not Applicable |
|
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 on pollution-induced skin damages used over a period of 2 weeks, based on clinical, instrumental and subjective evaluations done at predetermined time points Study Population:Healthy subjects in the age range of 18-50 years including both Males and Females (26 males and 74 females) will be recruited for the study. Sufficient number of healthy male and female subjects of age 18-50 years (both inclusive) will be screened to include 100 subjects divided in two groups. Each group will have 50 subjects (13 male and 37 female subjects, of which 15 subjects will belong to the non-sensitive skin type and remaining 35 subjects will have sensitive skin as assessed by Sting Test. Both groups will be balanced to have nearly equal/adequate representation of all skin types (Normal, Oily, Dry and Combination). Of the 50 subjects in each group, minimum 45 subjects should complete the study and 5 subjects are included additionally to account for drop outs if any. Trial has been completed sucessfully with 98 completers |