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CTRI Number  CTRI/2024/09/074275 [Registered on: 24/09/2024] Trial Registered Prospectively
Last Modified On: 06/09/2024
Post Graduate Thesis   
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetics Study for antiaging cream]  
Study Design  Other 
Public Title of Study   Study on Anti-Ageing product in both Indian males & females of 35 years to 60 years (both inclusive) 
Scientific Title of Study   Study code: 2324CICL002, Version 1, Dated 01 Aug 2024; A CLINICAL STUDY TO EVALUATE THE ANTI-AGEING EFFICACY OF HUMAN GROWTH FACTORS AND CYTOKINES CONTAINING COSMETIC SKIN SERUM (VC GROF) IN BOTH MALES AND FEMALES WITH SENSITIVE SKIN 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
2324CICL002  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pranami Kashyap 
Designation  Principal Investigator 
Affiliation  CIDP 
Address  32B First floor Rajendra Nagar Pusa Road

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 
Address  32B First floor Rajendra Nagar Pusa Road

Central
DELHI
110005
India 
Phone  9089348156  
Fax    
Email  p.kashyap@cidp-cro.com  
 
Details of Contact Person
Public Query  
Name  Abhishek Kashyap 
Designation  Project Manager 
Affiliation  CIDP Biotech India Pvt. Ltd. 
Address  32-B, First floor, Rajendra Nagar, Pusa Road, New Delhi-110005 INDIA, New Delhi, Delhi 110005

Central
DELHI
110005
India 
Phone  9999442984  
Fax    
Email  a.kashyap@cidp-cro.com  
 
Source of Monetary or Material Support  
Cipla Ltd. LBS Marg, Vikhroli(W), Mumbai 400083  
 
Primary Sponsor  
Name  Cipla Ltd 
Address  Cipla Ltd LBS Marg Vikhroli(W) Mumbai 400083 India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pranami Kashyap  CIDP Biotech India Pvt. Ltd.  Near Metro Piller Number 122, 32 B First floor Pusa Road Rajinder Nagar, New Delhi 110005, India
Central
DELHI 		 9089348156

p.kashyap@cidp-cro.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Good society of Ethical Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Subjects with minimum grade 2 of fine lines and wrinkles at crow’s feet, skin unevenness, density of pigmentary spots, cheek sebaceous pores as per Skin aging atlas 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Healthy male and female subjects with sensitive skin aged 35 years to 60 years’ old (both inclusive)
2. Fitzpatrick skin phototype III to VI
3. Subjects with minimum grade 2 of fine lines and wrinkles at crow’s feet, skin unevenness, density of pigmentary spots, cheek sebaceous pores as per Skin aging atlas, volume IV Indian skin type, by BAZIN & FLAMENT
4. Subjects not using fairness, skin, or spot lightening or antiaging or sunscreen creams/lotions (preferably about 60% non-users to be included)
5. Subjects not using any Vitamin C, retinol, niacinamide, glutathione, or any other serums/creams or supplements which might interfere with study assessments.
6. Subjects who have not undergone any aesthetic treatment (chemical peels, dermabrasion, lasers, Botox, fillers, etc.,) in the last 6 months and agreeing not to do in during the study period.
7. Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face.
8. Subject who agrees not to use any other product/treatment on their face during the study period.
9. Subject who agrees not to carry out bleaching or any other procedures including facial etc. on face during the study period.
10. Subject to agree to remove all Jewellery on/around face (e.g., necklace, earrings, if possible, nose ring), during VISIA imaging.
11. Female subjects with child-bearing potential willing to undergo Urine Pregnancy Test and to use acceptable methods of contraception.
12. Subjects who can read, write and understand the informed consent document and willing to give a written informed consent.
13. Subjects ready to follow instructions and study restrictions during the study period.

 
 
ExclusionCriteria 
Details  1. Subjects having known hypersensitivity to any of the study products or constituents.
2. Subjects who are pregnant or lactating or who are planning to become pregnant during the study (self-declared by subject on screening visit and test to be done on each evaluation visit except screening visit.
3. Participation in any other clinical trial up to 1 month prior to inclusion and during the study.
4. Subjects who have any significant skin pathology in the test area.
5. Subject who is currently taking any medication including food supplements, which the Investigator believes may influence the interpretation of the data.
6. Subject having chronic illness or had major surgery in the last year.
7. Subjects undergoing any treatment of any skin condition on their face/body.
8. Subjects having any allergy or sensitive to bar cleansing products, creams/lotions, artificial jewellery or anything else.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Clinical scoring of fine lines and wrinkles on forehead, crow’s feet wrinkles, Skin smoothness, skin suppleness, skin evenness, skin firmness, density of pigmentary spots & contrast of isolated pigmentary spot, skin radiance, ptosis and cheek sebaceous pores using Skin aging atlas Volume 4 Asian Skin Type by Dermatologists Investigator.

Instrumental Evaluations:
2. Evaluation of skin crow’s feet wrinkles, forehead fine lines, wrinkles & cheek sebaceous pores using ANTERA 3D Device
3. Evaluation of skin & spot color using Chromameter CR400
4. Evaluation of Skin hydration using Corneometer CM 825®/MPA 6
5. Evaluation of TEWL using Tewameter TM 300/TM Hex
6. Evaluation of skin firmness using Cutometer MPA 580
 		 D-14, D0, D28, D56 & D84 
 
Secondary Outcome  
Outcome  TimePoints 
1. Evaluation of skin crow’s feet wrinkles, forehead fine lines, wrinkles & cheek sebaceous pores using ANTERA 3D Device
2. Evaluation of skin & spot color using Chromameter CR400
3. Evaluation of Skin hydration using Corneometer CM 825®/MPA 6
4. Evaluation of TEWL using Tewameter TM 300/TM Hex
5. Evaluation of skin firmness using Cutometer MPA 580
 		 D-14, D0, D28, D56 & D84 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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)   07/10/2024 
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="2"
Days="24" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Suspended 
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  

Study Overview

  • Study Population:

    • Number of Subjects: 35
    • Demographics: Healthy males and females
    • Age Range: 35 to 60 years

  • Completion Goal:

    • Expected Completers: 30 subjects

  • Study Visits:

    1. Visit 1 (D-14)
    2. Visit 2 (D0)
    3. Visit 3 (D28) 
    4. Visit 4 (D56) 
    5. Visit 5 (D84) 

 
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