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CTRI Number  CTRI/2026/02/103568 [Registered on: 10/02/2026] Trial Registered Prospectively
Last Modified On: 11/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [cosmetic]  
Study Design  Other 
Public Title of Study   A study to assess the safety and anti-ageing benefits of a test product in healthy women. 
Scientific Title of Study   A clinical study to evaluate the efficacy and safety of a test product in providing anti-ageing benefits in healthy female trial participants 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SKIN/ICAG/2025-02; v 1.0 dated 23 Jan 2026  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mukta Sachdev 
Designation  Principal Investigator  
Affiliation  MS Clinical Research Pvt. Ltd 
Address  327/15, 1st Main Road, Cambridge Layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08040917253  
Fax    
Email  mukta.sachdev@msclinical.com  
 
Details of Contact Person
Scientific Query  
Name  Ritambhara 
Designation  Director-Business and operations 
Affiliation  MS Clinical Research Pvt. Ltd 
Address  327/15, 1st Main Road, Cambridge Layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  9945952952  
Fax    
Email  ritambhara@msclinical.com  
 
Details of Contact Person
Public Query  
Name  Sudhanthiran S 
Designation  manager- Techno commercial 
Affiliation  MS Clinical Research Pvt. Ltd 
Address  327/15, 1st Main Road, Cambridge Layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08883338954  
Fax    
Email  sudhan@msclinical.com  
 
Source of Monetary or Material Support  
Ichimaru Pharcos Co Ltd., 318-1 Asagi, Motosu-Shi Gifu 501-0475 Japan. 
 
Primary Sponsor  
Name  Ichimaru Pharcos Co Ltd., 
Address  318-1 Asagi, Motosu-Shi Gifu 501-0475 Japan. 
Type of Sponsor  Other [FMCG] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment
Modification(s)  		   Slovakia
India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Michaela Dubcekova  Apollo Business Centre  Regus office, Prievozská 4D, Blok E, Bratislava, 821 09, Slovakia

 		 -

mdubcekova@gmail.com 
Dr Mukta Sachdev  MS Clinical Research Pvt. Ltd  324, Department of skin science, 2nd floor, 1st Main Road, Cambridge Layout, Ulsoor
Bangalore
KARNATAKA 		 08040917253

mukta.sachdev@msclinical.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE INDEPENDENT ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy female trial participants 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  0.5% Bakuchiol Milky Lotion  Twice daily - Morning & Night (before sleep) for 8 weeks for the entire face.  
Comparator Agent  nil  NA 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Healthy adult female participants in general good health, as determined by medical history, general physical examination, and dermatological assessment.

Female participants aged 25 to 50 years (both inclusive) at the time of screening.

Presence of at least two clearly defined dark spots (including post-inflammatory hyperpigmentation, acne spots, or age spots) on each side of the face.

Presence of visible fine lines and wrinkles, as assessed by the dermatologist.

Presence of under-eye dark circles and visible facial pores, as assessed by the investigator.

Participants with Fitzpatrick skin phototypes I–II at the Slovakia site and III–IV at the India site, enrolled as per predefined site-wise allocation.

Participants free from excessive facial hair and without active acne, cuts, abrasions, fissures, wounds, lacerations, or any other active dermatological condition on the face, as determined by the investigator.

Participants willing to refrain from using any facial skincare products, treatments, or home remedies other than the provided test product for the duration of the study.

Participants willing to avoid cosmetic or dermatological procedures such as bleaching, facials, chemical peels, laser treatments, or similar procedures on the face during the study period.

Participants willing to avoid excessive sun exposure (defined as more than 30 minutes per day) and to use physical sun protection (e.g., umbrella or hat) during unavoidable exposure.

Participants willing to provide written informed consent, photography consent, and comply with all study visits and protocol requirements.

Participants who are willing and able to comply with the study protocol and investigator instructions. 
 
ExclusionCriteria 
Details  Presence of any clinically significant local skin irritation, dermatological disease, or active facial skin condition that may interfere with study evaluations.

Use of any systemic or topical medication, including dietary or food supplements, within 1 month prior to screening, that may affect study outcomes, as determined by the investigator.

History or presence of any clinically significant systemic disease, chronic illness, or major surgery within the past 1 year.

Unwillingness to remove facial jewellery (e.g., earrings, nose ring, necklace) during VISIA-CR imaging procedures.

Hairstyles covering a substantial portion of the forehead that cannot be adjusted for imaging assessments.

Ongoing dermatological treatment involving the face at the time of screening or during the study period.

Inability or unwillingness to maintain consistent routine use of personal cleanser, makeup, or sunscreen without changes during the study period. Participants with daily sunscreen use or daily/full makeup application will be excluded.

Known hypersensitivity or allergy to cosmetic products, cleansing agents, creams, lotions, metals, artificial jewellery, or any ingredient of the test product.

Pregnant or lactating participants (self-reported).

Participation in any clinical, cosmetic, or investigational study within 1 month prior to screening.

History of facial skin allergy, atopic dermatitis, psoriasis, or other chronic inflammatory skin conditions involving the face.

Employees of the sponsor, contract research organization (CRO), or study site staff directly involved in the conduct of the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Change from baseline in fine lines and wrinkles, under-eye dark circles, dark spots, skin texture, and pores, as assessed by dermatological visual evaluation and instrumental measurements.

• Assessment of dermatological safety and skin tolerability of the test product throughout the 8-week study duration.
 		 Day 0, Weeks 2, 4, and 8 
 
Secondary Outcome  
Outcome  TimePoints 
• Change from baseline in fine lines and wrinkles, under-eye dark circles, dark spots, skin texture, and pores, as evaluated by trial participant self-assessment  Day 0,Weeks 2, 4, and 8 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/02/2026 
Date of Study Completion (India) 30/04/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/04/2026 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
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 multicentric, multi-ethnic, open-label, full-face efficacy and safety study conducted over a period of 8 weeks in healthy adult female participants. The study comprises five visits including screening, baseline (Day 0), and follow-up assessment visits at Week 2, Week 4, and Week 8. A total of 40 participants will be enrolled across study sites, with approximately 35 participants expected to complete the study. Efficacy and safety will be evaluated through dermatological assessments, non-invasive instrumental measurements, imaging techniques, and participant self-assessments conducted under standardized conditions. Participants will apply the test product twice daily throughout the study period, and compliance will be monitored using participant diaries and product accountability. 
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