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CTRI Number  CTRI/2026/01/101810 [Registered on: 22/01/2026] Trial Registered Prospectively
Last Modified On: 20/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Topical application ]  
Study Design  Single Arm Study 
Public Title of Study   Effect of Regular Sunscreen Use on Skin Lightening Index 
Scientific Title of Study   Evaluation of improvement in skin lightening index with regular sunscreen use 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anannya S 
Designation  Consultant  
Affiliation  RENDER SKIN and HAIR 
Address  RENDER SKIN and HAIR, Canberra House, 97, Pantheon Rd, Egmore, Chennai, Tamil Nadu 600008

Chennai
TAMIL NADU
600008
India 
Phone  9445887101  
Fax    
Email  dranannya@renderclinic.com  
 
Details of Contact Person
Scientific Query
 
Name  Anannya S 
Designation  Consultant  
Affiliation  RENDER SKIN and HAIR 
Address  RENDER SKIN and HAIR, Canberra House, 97, Pantheon Rd, Egmore, Chennai, Tamil Nadu 600008


TAMIL NADU
600008
India 
Phone  9445887101  
Fax    
Email  dranannya@renderclinic.com  
 
Details of Contact Person
Public Query
 
Name  Anannya S 
Designation  Consultant  
Affiliation  RENDER SKIN and HAIR 
Address  RENDER SKIN and HAIR, Canberra House, 97, Pantheon Rd, Egmore, Chennai, Tamil Nadu 600008


TAMIL NADU
600008
India 
Phone  9445887101  
Fax    
Email  dranannya@renderclinic.com  
 
Source of Monetary or Material Support  
SILPHION RESEARCH PRIVATE LIMITED, NO. 95/44, 4TH FLOOR, I MAIN ROAD, GANDHI NAGAR, ADYAR (CHENNAI), CHENNAI CITY CORPORATION, CHENNAI-600020 
 
Primary Sponsor  
Name  SILPHION RESEARCH PRIVATE LIMITED 
Address  No. 95/44, 4th Floor, I Main Road, Gandhi Nagar, Adyar,Chennai- 600020 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Anannya S  RENDER SKIN AND HAIR   No. 95/44, 4th Floor, I Main Road, Gandhi Nagar, Adyar,Chennai- 600020
Chennai
TAMIL NADU 
9445887101

dranannya@renderclinic.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INDEPENDENT ETHICS COMMITTEE, RENDER SKIN AND HAIR   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NIL 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  A mineral sunscreen with SPF 40  A mineral sunscreen with SPF 40 (Safescreen Go) will be given to all the participants Day-time Use- Make sure the skin is clean and dry before application.Sunscreen should be applied 30 minutes before sun exposure About 4 to 6 pumps (1 to 1.4 ml) of sunscreen should be applied evenly across the face and neck, even on cloudy days or indoors near windows. Avoid getting the cream into your eyes, nostrils and mouth. Regular Application: Apply the sunscreen consistently every morning without skipping, and can be re-applied if outdoors for extended periods. Do not use any other topical creams, brightening agents, or treatments during the study unless instructed by the principal investigators. If dryness arises, soothing moisturizers will be given.  
Comparator Agent  NIL  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. 18–60 years
2. No use of any sunscreen in the preceding 4 weeks
3. Willingness to apply sunscreen daily and attend follow-up visits
4. Provided written informed consent
5. Comply with follow-up schedule 
 
ExclusionCriteria 
Details  1. Known allergy or sensitivity to sunscreen ingredients
2. Use of topical depigmenting or brightening agents in the past 4 weeks
3. Active dermatological or systemic illness affecting the face 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in skin lightening index from baseline to week 4 following regular use of sunscreen   Baseline, Week 4 
 
Secondary Outcome  
Outcome  TimePoints 
Participant-reported outcomes, including self-assessed improvement in skin lightening and satisfaction with overall skin appearance.
Assessment of skin lightening through clinical evaluation, standardized photography, and Reveal camera imaging.
Evaluation of product tolerability and safety based on participant feedback and investigator assessment.
 
Baseline, Week 4 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 4 
Date of First Enrollment (India)   02/02/2026 
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 Yet Recruiting 
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  
This open-label, single-arm, interventional study titled “Evaluation of Improvement in Skin Lightening Index with Regular Sunscreen Use” aims to assess the effect of daily application of a mineral-based sunscreen (Safescreen Go) on the skin lightening index over a four-week period in individuals who had not used sunscreen in the preceding four weeks. Phototanning and uneven skin tone result from cumulative ultraviolet (UV) and visible light exposure, which stimulate melanogenesis and oxidative stress. Regular sunscreen use mitigates these effects, but compliance is often poor due to cosmetic concerns. Mineral sunscreens containing non-nano zinc oxide and iron oxides offer broad-spectrum protection against both UV and visible light and are safer alternatives to conventional chemical filters. In this study, 30 participants aged 18–60 years will apply Safescreen Go daily on the face for four weeks, with reapplication after outdoor activity. No other brightening or sunscreen products will be permitted. Assessments will be performed at baseline and after four weeks, including clinical photography, Reveal® imaging, and objective colorimetric evaluation using the Dermalab Combo device to measure melanin, erythema, and lightening indices. Participant-reported outcomes on perceived lightening and satisfaction, as well as safety evaluations for irritation or breakout, will also be recorded. The primary objective is to determine the improvement in the Lightening Index after four weeks of regular sunscreen use, while secondary objectives include assessing user satisfaction and tolerability. Data will be analyzed using descriptive statistics and paired t-tests, with significance set at p < 0.05. The study will exclude individuals with known allergies to sunscreen ingredients, those using depigmenting agents, or those with active dermatological conditions, as well as pregnant or lactating women. All participants will provide written informed consent, and Institutional Ethics Committee approval will be obtained before initiation. Confidentiality will be maintained through coded data storage. Adverse events will be documented and addressed promptly, with serious events reported to the Ethics Committee. 
 
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