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CTRI Number  CTRI/2021/11/038145 [Registered on: 18/11/2021] Trial Registered Prospectively
Last Modified On: 29/03/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetic]  
Study Design  Other 
Public Title of Study   To study the safety, effectiveness of an anti-ageing serum in Healthy Human volunteers. 
Scientific Title of Study   Safety, Efficacy and Sensory Evaluation of Serum in Conferring facial skin Anti- ageing benefits in Healthy Human Volunteers. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CL/090/1021/STU Version No.: 1 of 26 th October 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajiv Joshi 
Designation  Principal Investigator 
Affiliation  C.L.A.I.M.S. PVT. LTD. 
Address  4 th floor, B wing, Modi House, C 10, Dalia Industrial Estate, New Link Road, Andheri (W), Mumbai400058,

Mumbai
MAHARASHTRA
400058
India 
Phone  02267758851  
Fax    
Email  rsjdrs@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Asma Hanif 
Designation  Research scientist 
Affiliation  ITC LIMITED 
Address  ITC LIMITED, 37 J. L. Nehru Road, Kolkata 700071, India

Kolkata
WEST BENGAL
700071
India 
Phone    
Fax    
Email  Asma.Hanif@itc.in  
 
Details of Contact Person
Public Query
 
Name  Asma Hanif 
Designation  Research scientist 
Affiliation  ITC LIMITED 
Address  ITC LIMITED, 37 J. L. Nehru Road, Kolkata 700071, India

Kolkata
WEST BENGAL
700071
India 
Phone    
Fax    
Email  Asma.Hanif@itc.in  
 
Source of Monetary or Material Support  
ITC LIMITED, 37 J. L. Nehru Road, Kolkata 700071, India 
 
Primary Sponsor  
Name  ITC LIMITED 
Address  37 J. L. Nehru Road, Kolkata –700071, India 
Type of Sponsor  Research institution 
 
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 Rajiv Joshi  C.L.A.I.M.S. PVT. LTD.  4 th floor, B wing, Modi House, C-10, Dalia Industrial Estate, New Link Road, Andheri (W), Mumbai-400058, Tel:91-22-66758851/52
Mumbai
MAHARASHTRA 
02266758851

rsjdrs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INDEPENDENT ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy human volunteers with acne scars will be included in the study 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Anti-ageing Serum  Site of application: On face. Method of application: 1-2 pumps of the provided test product will be applied on complete face after cleansing face. Product to be applied twice daily post cleansing face with the provided cleanser for period of 10 weeks. Product will be applied on volar forearm after cleansing once at baseline (Day 1). 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1. Indian/Asian female subjects
2. Healthy subjects between 35 and 60 years of age.
3. Skin in healthy state on the studied anatomic site (free of eczema, wounds, cuts, bruises,
inflammatory scar).
4. Mild to moderate wrinkles in the crow's feet area and/or nasolabial area and/or forehead
wrinkle.
5. Subjects who have not undergone any facial or anti-ageing procedures (e.g., Botulinum
toxin, dermal filler injections, laser resurfacing) in the past 3 months.
6.Subject should be willing to abstain from spa treatments/facials during the study period.
7. Subjects willing to abide by the study protocol and restriction (refrain from using any product
other than provided investigational product (IP)). 
 
ExclusionCriteria 
Details  1.Subjects who are pregnant or nursing (as confirmed by Urine pregnancy test for the
determination of Pregnancy) or planning to conceive in coming 4-5 months.
2. Subjects with a present condition of allergic response to any cosmetic product.
3. Subjects undergoing treatment for any skin care concern.
4. Subjects under chronic medication (e.g., aspirin-based products, anti-inflammatories,
antihistamines etc.) that might influence the outcome of the study.
5. Subjects who has used any systemic medication (antibiotics, oral contraceptive pills, steroids,
or any other anti-acne medication) or any topical facial medication with in past 4 weeks.
6. Having acne of severe incidence (presence of Nodules, Cysts or numerous pustules) which
requires pharmaceutical treatment.
7. Subjects with excessive facial hair or scars on test sites (face and volar forearm), which could
interfere with evaluation.
8. Subjects having cutaneous hypersensitivity. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Instrumental evaluation of
1.Fine lines, wrinkles , deep wrinkles, pores, smoothness of skin , skin texture,
hyperpigmentation spots, skin color (L, ITA), by Antera.
2. Skin firmness on area under the jawline on the neck and elasticity by CutoMeter.
3. Skin firmness and elasticity on cheek by CutoMeter
4. Skin hydration by MMSC.
5. Moisture in the deeper layers of skin by MMD (S15-1.5 mm deep).
6. Skin gloss by Skin Glossmerer
7. TEWL using VapoMeter.
8. Skin pH by skin- pH- Meter
Clinical evaluation of
1. Jin-Ho-Chung scale for wrinkles in crow’s feet area.
2. Wrinkles on forehead and in the nasolabial area.
3. Pore severity. 
Day 0(pre and post prodict application)
Week 1,
Week 2,
Week 4,
Week 6,
Week 8,
Week 10 
 
Secondary Outcome  
Outcome  TimePoints 
1.Clinical evaluation for tolerance
2.Self-assessment questionnaire for efficacy and tolerance.
3.Digital Photographs 
Day 0(pre and post prodict application)
Week 1,
Week 2,
Week 4,
Week 6,
Week 8,
Week 10

Digital Photographs will be taken at baseline, Week 4 and Week 10. 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="47" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/11/2021 
Date of Study Completion (India) 18/02/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Skin ageing is induced by both intrinsic and extrinsic factors. Intrinsic ageing is an inevitable physiological process which is mainly caused by gradual dermal atrophy, while extrinsic ageing is engendered by external environment factors such as air pollution, smoking, poor nutrition, and sun exposure. Thus resulting in appearance of fine lines and wrinkles, hyperpigmentation spots, and loss of elasticity, firmness. Application of face serum with effective anti-ageing actives can lead to anti-ageing benefits and delay signs of ageing, such as reduction in appearance of wrinkles and fine lines; hyper pigmentation and uneven skin tone; dryness; increase of firmness and brightness. This study aimed at the evaluation of anti-ageing and associated benefits from the test product: Anti-ageing Face Serum.

The study was designed to evaluate the effectiveness of the test product in reducing wrinkles and fine lines along with other signs of ageing, and overall improvement in skin condition basis instrumental, Dermatologist and Subject perception.

 

The key findings allow for following conclusions:

·         Test product (Product Code AAFS_1021) conferred significant reduction in fine lines and wrinkle (including deep wrinkles).

·         Test product (Product Code AAFS_1021) conferred significant improvement in pore appearance [i.e., reduced pore visibility, depth, size and density (number of pores per unit area)].

·         Test product (Product Code AAFS_1021) conferred immediate significant hydration and deep hydration.and deep penetration.

·         Test product (Product Code AAFS_1021) conferred significant reduction in hyperpigmentation (dark spots/age spots/UV spots/Post inflammatory hyperpigmentation) and improvement in luminescence, skin color and firmness.

·         Test product (Product Code AAFS_1021) is Non-sticky & lightweight, does not leave skin feel greasy/oily, or leave any unwanted residue; gives a soothing feel; instantly moisturized, soft and supple skin; smoothens skin texture instantly and improves overall appearance of skin, based on participant self-assessment.

·         Test product (Product Code AAFS_1021) showed efficacy/improvement in   fine lines visibility from the first use and showed improvement day by day; provides even skin tone and spotless clear skin; reduces dark spots, age spots and hyperpigmentation; reduces pore size, imparts youthful and healthier appearance to skin and makes skin appear younger looking, more vibrant, repairs skin, gives hydrated, clear and radiant skin and provides excellent anti-ageing benefits and youth boosting results based on participant self-assessment.

·         Test product (Product Code AAFS_1021) firms up jawline and neck, fades away deep wrinkles, reduces dark circles and under eye bags based on participant self-assessment.

·         Test product (Product Code AAFS_1021) maintains skin pH / acid mantle of the skin.

·         Test product (Product Code AAFS_1021) does not cause any skin irritation and is thus suitable, safe and well tolerated on skin.

Detailed findings:

1.     As per instrumental evaluations:

a)    There was a significant decrease in the Length of wrinkles on face: at Forehead, Crow’s feet and Nasolabial area, at the end of 4 weeks, 6 weeks, 8 weeks and 10 weeks as compared with the baseline (all p’s <0.001).

b)    Wrinkles depth showed a significant decrease at 2 weeks for forehead wrinkles as compared with the baseline (p<0.05).

c)     For a subset of consumers that showed presence of deep wrinkles (≥2 mm) in crow ’s feet area, there was a significant decrease in deep wrinkle length in crow ’s feet area Immediately after application, at the end of 6-weeks, 8 weeks and 10 weeks, as compared with the baseline (all p’s <0.01).

d)    There was a significant decrease in total volume of pores and pore index immediately post application and at 8 weeks as compared with the baseline (all p’s <0.05).

e)    There was a significant reduction in hyperpigmentation at the end of 4 weeks, 6 weeks, 8 weeks and 10 weeks as compared with the baseline (all p’s <0.01).

f)     There was a significant increase in skin luminescence at 8 weeks as compared with the baseline (p<0.05).

g)    There was a significant improvement in skin color/skin tone at 6 weeks and 8 weeks as compared with the baseline (all p’s<0.05).

h)    There was a significant improvement in Skin Firmness on face (Cheek) from 2 weeks to 10 weeks as compared with the baseline (all p’s<0.05).

i)      pH of skin was maintained in the pH range of 5.4-5.9.

j)     Test Product site showed significantly better skin hydration than untreated control site until 10th stripping i.e., Test products penetrates 10 layers deep.

k)    Instant improvement in hydration (both surface and deep hydration) was found post application as compared with the baseline (all p’s<0.05).

l)      Significant improvement was observed in deep skin hydration at 10 weeks as compared with the baseline (p<0.05).

 

2.      As per clinical evaluation by the Dermatologist:

a)    Mean Score of Wrinkles in Crow’s Feet Area using Jin Ho Chung Scale showed a significant improvement at 10 weeks as compared with the baseline (p<0.05).

b)    Mean score of Pore severity on entire face showed a significant decrease at the end of 4, 6, 8 and 10 weeks as compared with the baseline (all p’s<0.05).

 

3.     As per self-assessment for efficacy, there was significant improvement at all time points (all p’s <0.001) for

a)    Softness

b)    Smoothness

c)     Firmness

 

4.     As per self-assessment, post immediate application of the product, 100% of respondents agreed that:

·         the product is Non-sticky & lightweight

·         the product does not leave your skin feel greasy/oily

·         the product gives a soothing feel to your skin

·         the product improves overall appearance of your skin

·         the product does not leave any unwanted residue on the skin

·         the product makes your skin feel instantly moisturized

·         the product makes your skin feel instantly soft and supple

·         the product smoothens your skin texture instantly

·         the product does not cause any skin irritation and thus is safe for skin.

 

5.     As per self-assessment, at Week 4, 100% of respondents agreed that:

·         the product gives a soothing feel to your skin

·         the product improves overall appearance of your skin

·         the product started working on fine lines from the first use and improved day by day

·         the product reduces pore size

·         the product provides even skin tone and spotless clear skin

·         the product reduces dark spots, age spots and hyperpigmentation

·         the product penetrates deep into the skin to give hydrated, clear and radiant skin

·         the product renews, restores & repairs skin

·         the product imparts youthful and healthier appearance to your skin

·         like the product based on its overall performance after continuous usage

·         the product made their skin appear younger looking and more vibrant

·         As compared to other anti-ageing products they may have used, this product provided excellent anti-ageing benefits and youth boosting results.

 

6.     As per self-assessment, at Week 10, 100% of respondents agreed that:

·         the product gives a soothing feel to your skin

·         the product improves overall appearance of your skin

·         the product started working on fine lines from the first use and improved day by day

·         the product reduces pore size

·         the product provides even skin tone and spotless clear skin

·         the product penetrates deep into the skin to give hydrated, clear and radiant skin

·         the product renews, restores & repairs skin

·         the product imparts youthful and healthier appearance to your skin

·         like the product based on its overall performance after continuous usage

·         the product firms up jawline and neck.

·         the product faded away deep wrinkles.

·         the product reduces dark circles and undereye bags.

·         As compared to other anti-ageing products they may have used, this product provided excellent anti-ageing benefits and youth-boosting results.

 

7.     The test product was deemed to be safe as per AE monitoring, Self-assessment-Tolerance (prickling, tingling, itching, burning), and clinical assessment for safety (erythema, oedema, cutaneous dryness).


 
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