| CTRI Number |
CTRI/2024/09/073333 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
single center, observational study |
| Study Design |
Other |
|
Public Title of Study
|
Study on Understanding Skin Features in Healthy Women Using Facial Pictures in India |
|
Scientific Title of Study
|
A study to evaluate the Skin characterization in healthy female
participants through Facial image collection and Analysis in India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2324CICL044 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pranami Kashyap |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
32 B, First floor, Pusa Road, Rajinder Nagar,
New Delhi-110005, India
110005
India
Central
DELHI
110005
India |
| Phone |
9089348156 |
| Fax |
|
| Email |
p.kashyap@cidp-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranami Kashyap |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
32 B, First floor, Pusa Road, Rajinder Nagar,
New Delhi-110005, India
110005
India
Central
DELHI
110005
India |
| Phone |
9089348156 |
| Fax |
|
| Email |
p.kashyap@cidp-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Hirak Jyoti NATH |
| Designation |
Project Manager |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
32 B, First floor, Pusa Road, Rajinder Nagar,
New Delhi-110005, India
Central
DELHI
110005
India |
| Phone |
8638742731 |
| Fax |
|
| Email |
h.nath@cidp-cro.com |
|
|
Source of Monetary or Material Support
|
| Unilever Research and Development,
5F, Shanghai U66 Office,
China |
|
|
Primary Sponsor
|
| Name |
Unilever Research & Development |
| Address |
5F, Shanghai U66 Office,
China |
| Type of Sponsor |
Other [Cosmetic company] |
|
|
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 |
| Hirak Jyoti NATH |
CIDP Biotech India Pvt. Ltd. |
32-B, First Floor, Pusa
Road, Rajinder Nagar,
New Delhi-110005,
Central
DELHI |
8638742731
h.nath@cidp-cro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GSER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
mild to moderate ageing signs (hyperpigmentation, enlarged pores, under eye dark circle, lines or wrinkles; lack of skin glow or radiance, sagging) etc. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Indian females, age between 18-65
Be in general good health
Understand the test procedure, read, and sign an appropriate Informed Consent Form
indicating their willingness to participate in case of any difficulty in signing the ICF by
the participant and LAR will sign the ICF on behalf of the participant
Participants need to be competent that is able to understand what is to take place and
able to provide a free decision on agreeing to the activity or taking part in the study on
this
Participants must be able to read and understand study instructions and any other
relevant study documents
Willing to follow the lifestyle and dietary restrictions.
The participants are divided into 5 different age groups, specific inclusion criteria for
each age group mentioned in the below
18 to 29 100 participants 50 participants with mild to moderate condition of either one the aging signs or different combination of the aging signs on hyperpigmentation enlarged pores under eye dark circle etc. at the discretion of the study dermatologist 50 participants not restriction with above criteria
30-39 100 participants cover mild to moderate condition of either one or different aging signs as on hyperpigmentation, enlarged pores, under eye dark circle, lines or wrinkles lack of skin glow or radiance at the discretion of the study dermatologist
40-49 100 participants cover any of the aging signs as hyperpigmentation lines or wrinkles scale with mild, moderate to severe condition lack of skin radiance, enlarged pores, sagging etc at the discretion of the study dermatologist
50-59 100 participants 100 participants cover any of the aging signs as hyperpigmentation lines or wrinkles scale with mild moderate to severe condition lack of skin radiance, enlarged pores, sagging etc at the discretion of the study dermatologist
60-65 50 participants 100 participants 100 participants cover any of the aging signs as hyperpigmentation, lines or wrinkles scale with mild, moderate to severe condition lack of skin radiance, enlarged pores, sagging etc at the discretion of the study dermatologist
|
|
| ExclusionCriteria |
| Details |
Have used any skin lightening or anti-aging benefits products or any other dermatological
treatment at least one month before this study
Participant having done facial injections and or aesthetic surgery
Be involved in any aspect of test administration that is evaluating or overseeing activities related to product
Have participated in any clinical study involving the test sites within the previous 6 months or is participant participating in any clinical study concurrently
Have a history of any type of cancer, including but not limited to any type of skin cancer squamous or basal cell carcinoma at the treatment site or history of malignant melanoma at any body site
Have a history of skin disease or the presence of a skin condition on the test sites that the Investigator feels would interfere with the study
Be taking antihistamines greater than 3x or week or anti-inflammatory greater than 8x or week on a regular basis or has the participant taken systemic or topical steroidal medications within 4 weeks of study enrolment
Have any of the following conditions or factors that the investigator believes may affect the response of the skin or the interpretation of the test results including but not limited to diabetes pregnancy and lactation
Have any cuts/abrasions on the test site at baseline
Have had a suspicious skin lesion removed by a dermatologist at any time for face
The participant is an employee of a sponsor or the site conducting the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Checking the aging characteristics from women of age range 18 to 65 years old using facial images captured by VISIA CR instrument |
Single day study |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="450"
Sample Size from India="450"
Final Enrollment numbers achieved (Total)= "450"
Final Enrollment numbers achieved (India)="450" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/09/2024 |
| Date of Study Completion (India) |
12/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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)
|
Title Evaluation of Skin Characteristics in Healthy Female Participants through Facial Image Collection and Analysis in India Objective To explore and understand the skin characteristics of Indian females across different age groups using facial image analysis. This study aims to contribute to the development of the Bad Ager model and refine skincare technologies for the Consumer Benefit Platform (CBP). Methodology Participants: 450 healthy Indian females of varying ages. Image Collection: Facial images captured with the VISIA CR-05 system, including Standard 1, Standard 2, Raked, CP, PP, and UV modes, from both side and front views. Parameters: Analysis of lines/wrinkles, skin color, blemish color, pore size, gloss, and overall texture. Expected Outcomes: Insights into age-related skin characteristics specific to Indian females, aiding in the advancement of targeted skincare solutions and technological innovations. |