| 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
|
|
|
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
|
|
|
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. |