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CTRI Number  CTRI/2023/09/057287 [Registered on: 06/09/2023] Trial Registered Prospectively
Last Modified On: 16/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Safety and Efficacy of Cosmetic Product]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study to check the safety and effectiveness of Anti-Ageing and skin brightening gel in healthy adult female subjects. 
Scientific Title of Study   A Randomized, Double Blind, Two Arm, Parallel, Placebo-Controlled, Safety and Efficacy Study of Anti-Ageing and Skin Brightening Gel. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NB230027-GB Version - Final 1.0 Dated 18 Aug 23  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nayan Patel 
Designation  Medical Director 
Affiliation  NovoBliss Research Private Limited 
Address  Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj

Gandhinagar
GUJARAT
382421
India 
Phone  9909013286  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Patel 
Designation  Medical Director 
Affiliation  NovoBliss Research Private Limited 
Address  Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj

Gandhinagar
GUJARAT
382421
India 
Phone  9909013286  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Public Query  
Name  Maheshvari Patel 
Designation  Director Operations and Strategic Management 
Affiliation  NovoBliss Research Private Limited 
Address  Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj

Gandhinagar
GUJARAT
382421
India 
Phone  9909013236  
Fax    
Email  maheshvari@novobliss.in  
 
Source of Monetary or Material Support  
Green Mountain Biotech Limited Yitzhak Sadeh St 8, Tel Aviv-Jaffa 6701203, Israel  
 
Primary Sponsor  
Name  Green Mountain Biotech Limited 
Address  Yitzhak Sadeh St 8, Tel Aviv-Jaffa 6701203, Israel  
Type of Sponsor  Other [Manufacturer - Cosmetics] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nayan Patel  NovoBliss Research Pvt. Limited   Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj
Gandhinagar
GUJARAT 		 9909013286

dr.nayan@novobliss.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACEAS – Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy adult non-pregnant/non-lactating females with an age of 35 – 55 having Crow’s Feet Wrinkles and Fine Lines. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Gel A  Frequency: Twice a day on clean skin Duration: for 60 days Route of Administration: Topical application.  
Intervention  Gel B  Frequency: Twice a day on clean skin Duration: for 60 days Route of Administration: Topical application.  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1) Age: 35 to 55 years (both inclusive) at the time of consent.
2) Sex: Healthy and non-pregnant/non-lactating females.
3) Subjects who are generally in good health as determined by/form recent medical history.
4) Female of child bearing capacity must have a self-reported negative pregnancy test.
5) Subjects having mild to moderate crows’ feet wrinkles.
6) Subjects having a score of at least “mild skin aging” based on PGA at screening visit.
7) Subjects having a score of at least “mild skin pigmentation” based on Skin Pigmentation Score at screening visit.
8) Subjects having Glogau Skin Age II or III as assessed by the Dermatologist/ Dermatologist Trained Evaluator.
9) Subjects who are willing to forgo cosmetic procedures for the duration of the study.
10) Subjects who are able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
11) Subjects who are willing not to introduce any new soaps, cleansers, lotions, creams, or any other face products etc. for the duration of the study.
12) Subjects who are willing to give written informed consent and are willing to follow the study procedure.
13) Subjects who commit not to use medicated/ prescription anti-ageing and skin brightening products or any other anti-ageing and skin brightening products other than the test products for the entire duration of the study.
14) Subjects who are willing to use test products throughout the study period. 
 
ExclusionCriteria 
Details  1) Subjects having a history of allergy or sensitivity to the test treatments ingredients.
2) Subjects who have pre-existing or dormant dermatologic conditions (e.g., psoriasis rashes, eczema, seborrheic dermatitis, acne or any other) that could interfere with the outcome of the study as determined by the Investigator.
3) Subjects who have used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
4) Subjects who have applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
5) Subjects not willing to avoid unprotected sun or other UV radiation exposure during the study period.
6) Subjects having a history of alcohol or drug addiction.
7) Subjects who have used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
8) Subjects who have applied any topical retinoids or glutathione within 2 weeks of the screening visit or anticipates having to use at any point during the study.
9) Subjects not willing to avoid unprotected sun or other UV radiation exposure during the study period.
10) Subjects who are currently pregnant/breastfeeding or planning to become pregnant during the study period.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To assess the effectiveness of the test products in terms of change in Skin Elasticity from baseline using Cutometer Dual MPA 580.
2. To assess the effectiveness of the test products in terms of change in CIE L, a b, ITA angle, skin brightness, skin pigmentation using Skin Colorimeter CL 400.
3. To assess the effectiveness of the test products in terms of change in Skin Glow using Skin Glossymeter GL 200.
4. To assess the effectiveness of the test products in terms of change in crow’s feet area wrinkles, fine lines, skin texture – roughness, dryness, wrinkles, smoothness using Visioscan (C+K Instrument).
5. To assess the effectiveness of the test products in terms of change in facial photographs using digital photographs.
6. To assess the effectiveness of the test products in terms of change in wrinkles, fine lines & pores using Image-pro Software.
 		 1. Day 01, Day 30, Day 60
2. Day 01, Day 30, Day 60
3. Day 01, Day 30, Day 60
4. Day 01, Day 30, Day 60
5. Day 01, Day 60
6. Day 01, Day 60

 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effectiveness of the test products in terms of change in skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness & sallowness using PGA Scoring as in Griffith’s Scale.  Day 01, Day 30, Day 60 
To assess the effectiveness of the test products in terms of change in level of photodamage using Glogau skin age classification.  Day 01, Day 30, Day 60 
To assess the effectiveness of the test products in terms of change in skin pigmentation using skin pigmentation scoring.  Day 01, Day 30, Day 60 
To assess the consumer perception of the test products regarding the test product’s effect on skin firmness, appearance, radiance, acne or skin breakouts, glowing skin tone, blemishes & dark skin patches removal using subject perception questionnaire.  Day 01, Day 30, Day 60 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/09/2023 
Date of Study Completion (India) 01/12/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

This is a Randomized, Interventional, Prospective, Double Blind, Two Arm, Comparative, Parallel, Placebo-Controlled, Safety and Efficacy Study of Anti-Ageing and Skin Brightening Gel.

Total of 44 adult female subjects (22 Subjects/Arm) of age 35 – 55 years will be enrolled to get 40 completed subjects (20 Subjects/Arm)

There will be a total of 3 visits in the study. The subject will be instructed to visit the facility as per the below visits:

Visit 01 (Day 01): Screening, Enrolment and Treatment Start Phase (Week 00)

Visit 02 (Day 30): Treatment Phase (Week 04)

Visit 03 (Day 60): End of Study (Week 08)

The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent. Subjects will be asked to not wear any makeup on the face on screening day.

Assessment of efficacy parameters before test products usage will be done on Day 01 after enrolment and after test products usage will be done on Day 30 (± 2 days) and Day 60 (± 2 days) as listed-below.

PGA scoring using Griffiths scale – skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness.

Glogau skin age.

Skin pigmentation scoring.

Skin elasticity: Cutometer Dual MPA 580.

Skin colorimeter CL 400: CIE L*, a* b*, ITA angle, skin brightness, skin pigmentation reduction.

Skin Glossymeter GL200 - skin glow.

Visioscan (C+K instrument): crow’s feet area wrinkles, fine lines, skin texture – roughness, dryness, wrinkles, smoothness.

Digital photographs: facial photographs before test products usage on day 1 and post-usage at day     60.

Image-pro software - image analysis day 01 vs day 60 - wrinkles, fine lines, pores.

Subjective product perception assessment regarding the test product’s effect on skin firmness, appearance, radiance, acne or skin breakouts, glowing skin tone, blemishes and dark skin patches       removal etc.

Descriptive Interim analysis will be done upon completion of Visit 02 (Day 30 ± 2) of the study. Executive summary report and raw data will be shared with sponsor.


 
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