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CTRI Number  CTRI/2025/06/089685 [Registered on: 27/06/2025] Trial Registered Prospectively
Last Modified On: 22/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetic]  
Study Design  Other 
Public Title of Study   To study the effect of serum in reducing pimples and making the skin look younger in Women. 
Scientific Title of Study   A monocentric, single group, 4 week trial to evaluate the efficacy of a serum in inflammatory acne and skin anti ageing and in use tolerance of the serum. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CL/042/0525/STU Version No.: 1 of 14th May 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajiv Joshi 
Designation  Principal Investigator - Consultant Dermatologist 
Affiliation  Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD. 
Address  5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East

Mumbai
MAHARASHTRA
400093
India 
Phone  66758851  
Fax    
Email  rsjdrs@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ms Preetha Paul 
Designation  Senior manager - TQM 
Affiliation  Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD. 
Address  5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East

Mumbai
MAHARASHTRA
400093
India 
Phone  66758851  
Fax    
Email  preetha@claimsclinical.com  
 
Details of Contact Person
Public Query  
Name  Ms Preetha Paul 
Designation  Senior manager - TQM 
Affiliation  Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD. 
Address  5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East

Mumbai
MAHARASHTRA
400093
India 
Phone  66758851  
Fax    
Email  preetha@claimsclinical.com  
 
Source of Monetary or Material Support  
Earthy Biome Pvt. Ltd. 14, Navjeevan Vihar, New Delhi – 110017 (India)  
 
Primary Sponsor  
Name  Earthy Biome Pvt. Ltd. 14 
Address  Navjeevan Vihar, New Delhi – 110017 (India)  
Type of Sponsor  Other [Cosmetic company] 
 
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  Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.)  5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
Mumbai
MAHARASHTRA 		 66758851

rsjdrs@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CLAIMS 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 and wrinkles will be included in the study. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BLEMISH BALANCE SERUM  Face will be washed and dabbed dry with towel. A thin layer of the Face Serum (approximately 0.5 ml) will be applied on the face, once at night for a duration of 30 days. 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria
Modification(s)  
Age From  30.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1. Voluntary women from 30 years to 55 years of age.
2. Participants with inflammatory acne, Blemish, Sunspots, PIH.
3. 10 participants with blemish (at least 1 hyperpigmented spot like PIH)
4. 10 Participants with mild to moderate wrinkles in crow’s feet area.
5. Having apparently healthy skin on test area.
6. Willingness to discontinue the use of other cosmetic products on face during the course of
the study.
7. Willing to avoid unusual sun exposure as far as possible for the entire study duration.
8. Accepting not to use products with the same end benefit during the entire study duration.
9. Cooperating, informed of the need and duration of the examinations, and ready to comply
with protocol procedures.
10. Ready to provide consent, having been informed orally and in writing of all information
concerning the study procedures and study objectives. 
 
ExclusionCriteria 
Details  1. Female who is pregnant by UPT or lactating women.
2. Participants having any hard damage to skin (e.g., excessive sunburn or suntan).
3. Participants hypersensitive to any of the components of the test product.
4. Participants on any systemic medical treatment which may interfere with the performance of
the study treatment (presently or in the past 1 month). 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. 3D Imaging for acne, wrinkles, skin texture, blemish and pore cleansing efficacy.
2. Clinical grading for inflammatory acne count.
3. Self-assessment for product efficacy. 		 Day 0, Day 30 
 
Secondary Outcome  
Outcome  TimePoints 
1. Clinical evaluation for in-use skin tolerance.
2. Self-assessment questionnaire for in-use tolerance. 		 Day 30 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   30/06/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
Improvement in overall facial skin appearance is most rapidly achieved through enhanced
moisturization. Moisturization occurs by increasing the water content of the epidermis, thereby
improving skin texture and reducing the appearance of fine lines and superficial wrinkles. The
skin naturally achieves hydration through dermal glycosaminoglycans (GAGs) such as hyaluronic
acid [1]. Hyaluronic acid (HA), also known as hyaluronan, is a linear carbohydrate
polysaccharide found in all living organisms
BLEMISH BALANCE SERUM consists of anti-ageing ingredients, hence it would be effective in reducing acne and visible signs of ageing. The
purpose of this study is to evaluate and validate the claims both objectively with the use of
instruments and subjectively by clinical grading and self-assessment questionnaire.
 
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