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CTRI Number  CTRI/2025/01/078903 [Registered on: 17/01/2025] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [pre ageing study]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to check the effectiveness of a retinol serum with moisturizer in reducing early signs of aging. 
Scientific Title of Study   A full face, randomized study to evaluate the efficacy and tolerance of regimen of Retinol Serum with Moisturizer versus Moisturizer alone in reducing early signs of ageing in Indian females over 8 weeks. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SKIN/JJAG/2024-01, Version 1.0, Dated: 18 Dec 2024  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  08040917243  
Fax    
Email  mukta.sachdev@msclinical.com  
 
Details of Contact Person
Scientific Query  
Name  Ritambhara 
Designation  Director- Business and Operations 
Affiliation  MS Clinical Research 
Address  327/15, 1st Main Road, Cambridge Layout, Ulsoor,

Bangalore
KARNATAKA
560008
India 
Phone  08040917243  
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  08040917243  
Fax    
Email  sudhan@msclinical.com  
 
Source of Monetary or Material Support  
Johnson and Johnson Pte. Ltd 2 Science Park Drive, The Ascent, Unit 07-13, Singapore 118222. 
 
Primary Sponsor  
Name  MS Clinical Research Pvt Ltd 
Address  327/15, 1st Main Road, Cambridge Layout, Ulsoor, Bangalore- 560008  
Type of Sponsor  Contract research organization 
 
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 Mukta Sachdev  MS Clinical Research Pvt. Ltd  Department of Skin Sciences, 324, Second 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 Independant Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Female subjects with early ageing signs like fine lines, under eye wrinkles, skin roughness. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Moisturizer  In the morning, subjects will be asked to wash their face with cleanser, apply moisture and sunscreen. In the evening, subjects will be asked to wash their face with cleanser, apply moisture for 8 weeks on the full face. 
Intervention  Moisturizer and Retinol Serum  In the morning, subjects will be asked to wash their face with cleanser, apply moisture and sunscreen. In the evening, subjects will be asked to wash their face with cleanser, apply moisture and retinol serum for 8 weeks on the full face. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Female subjects aged between 20-40 years (both ages inclusive)
2. Subjects who have not used retinol-based products minimum 8 weeks prior to enrollment.
3. Subjects who only use base moisturizer for a minimum at least 4 weeks prior to enrollment.
4. Subjects with self-declared non-sensitive skin and as confirmed by modified Baumann’s questionnaire with score less than 24.
5. Subjects with roughness score of greater than or equal to 4 (0-9) measured by Dermatological Assessments.
6. Subjects with underneath eye wrinkles score of greater than or equal to 2 (grades 0-5) as per atlas measured by Dermatological Assessments.
7. Subjects with 1hour sebum secretion rate of more than 90 (oily skin) in each test group preferably in equal ratio.
8. Subjects with 1hour sebum secretion rate of less than 90 (non-oily skin) in each test group preferably in equal ratio.
9. Subjects with all skin types, preferably in equal ratio of normal, oily, dry and combination types as confirmed by general health screening form.
10. Subjects with Fitzpatrick phototype III, IV, V and VI as confirmed by general health screening form.
11. Subject free of excessive hair, cuts, abrasions, fissures, wounds, lacerations, or any other skin conditions on the face.
12. Subjects who agree not to use any other product or treatment or home remedy or except the provided products on their face during the study period.
13. Subjects who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period.
14. Subjects who agree not to expose to excessive direct sun light (sun exposure not more than half an hour daily and during that time use of umbrella to cover face).
15. Subjects willing to give a voluntary written informed consent, photography re-lease and agree to come for regular follow-up.
16. Subjects willing to abide by and comply with the study protocol. 
 
ExclusionCriteria 
Details  1. Subjects who do not agree to abstain from other cosmetic products including colour cosmetics
2. Subjects who work outdoors and those with direct UV or sun exposure
3. Subjects with known skin conditions that may impact the assessment.
4. Subjects with any other signs of significant local irritation or skin disease.
5. Subjects currently taking any medication and/or taken medication within 30 days prior to the study, which the investigator believes may influence the interpretation of the data, such as but not limited to oral isotretinoin.
6. Subjects having clinically significant systemic or cutaneous disease, chronic illness or major surgery in the last year.
7. Subjects undergoing treatment of any skin condition on their face.
8. Subjects not willing to discontinue other topical facial products.
9. Subject who are allergic and/or have known sensitivity to any of the treatment products and or ingredients of the treatment products that will be provided. Subjects who have participated in a similar clinical study 4 weeks before this study.
10. Subjects who are pregnant and/or planning to get pregnant and/or nursing and/or planning to nurse (self-declared).
11. Subjects who are on any kind of supplements or taking nutraceuticals.
12. Subjects who are employees of the sponsor or the CRO. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in early signs of ageing after usage of a regimen containing retinol in comparison to baseline.  Baseline, Week 1, Week 4, Week 8, 3 days after week 8. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Improvement in early signs of ageing after using a regimen containing retinol in comparison to baseline.
2. Improvement in hydration and early signs of ageing after using the moisturizer in comparison to baseline
3. Dermatological tolerability of test products.  		 Baseline, Week 1, Week 4, Week 8, 3 days after week 8. 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   28/01/2025 
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="0"
Months="2"
Days="10" 
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   Skin of colour populations show varied signs of ageing as compared to populations of lighter complexions. Photoaging in Asians is commonly seen as hyperpigmentation, seborrheic dermatitis, melasma as compared to structural changes. Early signs of aging in the Skin of Colour (SOC) population often present differently compared to lighter skin tones. These signs include the appearance of hyperpigmentation, such as melasma or dark spots and wrinkles. SOC is also prone to changes in skin texture, including roughness and uneven tone. There are several treatment options to mitigate signs of ageing such as retinoids. This study aims to compare and evaluate a regimen of retinol with hyaluronic acid with hyaluronic acid alone in early ageing Indian women.

This study is planned to be a full face, randomized controlled comparative study and will be conducted over approximately 9 weeks and will include 6 visits. Visit 1- Screening visit, Wash out period 3 to 5days, Visit 2: Baseline visit (Week 0- W0), Visit 3: Week 1 (W1) assessment visit, Visit 4: Week 4 (W4) assessment visit, Visit 5: Week 8 (W8) assessment visit, Visit 6: 3 days (up to 5 days) after W8 assessment visit. 

On the screening visit, subjects will be instructed to wash their face with cleanser and wait for approximately 1hour during which dermatological assessments will be performed. 
 On visits 2, 3, 4, 5, Imaging using VISIA CR, Antera, Dermatological assessments (for ageing, fine lines and wrinkles, skin texture and skin tone), Corneometer, Tewameter, cutometer, Visioscan, Sebumeter and self assessment questionnaires will be performed. 
Test products and subject diary will be dispensed on visit 2 and subjects will be given instructions on their usage. 

On visit 5, test products will be retrieved and subjects will be instructed to use the additional products for 3 additional days. On visit 6, similar dermatological, instrumental and imaging assessments will be performed to evaluate regression effects. 




 
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