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CTRI Number  CTRI/2024/11/076781 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 08/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [oral supplement]  
Study Design  Single Arm Study 
Public Title of Study   A study to assess the effectiveness of an oral supplement in providing skin benefits.  
Scientific Title of Study   A study to evaluate the efficacy of the oral supplement in providing various skin benefits in healthy female subjects  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SKIN/ICSS/2023-03 version 1.0 dated 04 Oct 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Roshni Rai 
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt. Ltd. 
Address  Department of Skin Sciences No. 324, 2nd Floor 1st Main Road Cambridge Layout Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08040917253  
Fax    
Email  roshni.rai@msclinical.com  
 
Details of Contact Person
Scientific Query  
Name  Ritambhara 
Designation  Director operations and business 
Affiliation  MS Clinical Research Pvt. Ltd. 
Address  Department of Skin Sciences No. 324, 2nd Floor 1st Main Road Cambridge Layout Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08040917253  
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  Department of Skin Sciences, No. 324, 2nd Floor 1st Main Road Cambridge Layout Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08040917253  
Fax    
Email  sudhan@msclinical.com  
 
Source of Monetary or Material Support  
Ichimaru Pharcos Co Ltd. 
 
Primary Sponsor  
Name  Ichimaru Pharcos Co Ltd. 
Address  318-1 Asagi, Motosu-Shi Gifu 501-0475 Japan  
Type of Sponsor  Other [Cosmetic industry] 
 
Details of Secondary Sponsor  
Name  Address 
NA  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 Roshni Rai  MS Clinical Research Pvt. Ltd.  Department of Skin Sciences No. 324, 2nd Floor 1st Main Road Cambridge Layout Ulsoor
Bangalore
KARNATAKA 		 08040917253

roshni.rai@msclinical.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Independant Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Subjects with spots on the face.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Rice ceramide – oral supplements  Subjects will be instructed to dissolve the contents of a sachet in water and drink once a day for 4 weeks.  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1. Female adult subjects in general good health as determined from a recent medical history, general physical examination, dermatological assessment.
2. Subjects in the age group of 25-65 years both ages inclusive.
3. Subjects with skin phototype III to V, min 50% subjects need to be phototype III.
4. Subjects with close resemblance to the Thai population.
5. Subject presenting at least 1 well defined dark spot on the face.
6. Subjects free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face as determined by the dermatologist.
7. Subject who agrees not to use any other product or treatment or home remedy except the provided product on their face during the study period other than the test product.
8. Subjects who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period.
9. Subjects who agree not to have direct and excessive sun exposure, not more than half an hour daily and during that time use of umbrella to cover face.
10. Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up.
11. Subjects willing to abide by and comply with the study protocol.  
 
ExclusionCriteria 
Details  1. Subject with any other signs of significant local irritation or skin disease.
2. Subject currently taking any medication, which the Investigator believes may have an impact on the skin and study results.
3. Subject having clinically significant systemic or cutaneous disease, chronic illness or had major surgery in the last year.
4. Subjects undergoing any treatment of any skin condition on their face
5. Subjects not willing to discontinue other topical facial products.
6. Subject allergic or sensitive to bar, cleansing products, cosmetics, creams/lotions, artificial jewelery or anything else.
7. Subjects who are pregnant or nursing.
8. Subjects on any medical treatment either systemic or topical in the past 1 month or currently taking medication including food supplements. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Improvement in wrinkles, fine lines and dark spots at different timepoints in
comparison to the baseline using Antera and dermatological evaluations.
2. Improvement in skin hydration at all defined timepoints in comparison to
the baseline using Corneometer.
3. Improvement in skin water barrier function at all defined timepoints
in comparison to the baseline using TEWL.
4. Improvement in the skin color in comparison to baseline at all defined timepoints using Spectrophotometer.
5. Improvement in skin attributes in comparison to baseline at all defined timepoints using and in skin attributes using VISIA CR imaging.  		 baseline, week 1, week 2, week 4
 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate dermatological safety and tolerability of the test product under
regular (once daily) intake for 4 weeks. 		 baseline, week 1, week 2, week 4  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   22/11/2024 
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="1"
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   The aim of the study is to determine the efficacy of the test product (oral supplement) in providing skin benefits. Subjects will be screened and enrolled based on inclusion and exclusion criteria. Dermatological and instrumental assessments to evaluate skin colour, skin tone, fine lines and wrinkles, skin hydration and water barrier will be conducted at baseline, week 1, week 2 and week 4 time points.  
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