| CTRI Number |
CTRI/2026/03/106639 [Registered on: 20/03/2026] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Sunscreen] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the efficacy and safety of tinted and non-tinted sunscreen in topical steroid damaged face. |
|
Scientific Title of Study
|
Efficacy and safety of tinted vs non-tinted sunscreen use in topical steroid damaged face (TSDF): A Randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ATUL KEJARIWAL |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES,BHUBANESHWAR,ORISSA |
| Address |
DEPARTMENT OF DERMATOLOGY, VENEREOLOGY & LEPROSY, KALINGA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR
Khordha
ORISSA
751024
India |
| Phone |
9040516433 |
| Fax |
|
| Email |
atulkejariwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
LAXMAN BESRA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES,BHUBANESHWAR,ORISSA |
| Address |
DEPARTMENT OF DERMATOLOGY, VENEREOLOGY & LEPROSY, KALINGA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR
Khordha
ORISSA
751024
India |
| Phone |
9500282040 |
| Fax |
|
| Email |
laxman.derm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
LAXMAN BESRA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES,BHUBANESHWAR,ORISSA |
| Address |
DEPARTMENT OF DERMATOLOGY, VENEREOLOGY & LEPROSY, KALINGA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR
Khordha
ORISSA
751024
India |
| Phone |
9500282040 |
| Fax |
|
| Email |
laxman.derm@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF DERMATOLOGY, VENEREOLOGY and LEPROSY, KALINGA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR |
|
|
Primary Sponsor
|
| Name |
ATUL KEJARIWAL |
| Address |
DEPARTMENT OF DERMATOLOGY, VENEREOLOGY AND LEPROSY, KALINGA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR, ORISSA,751024 |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
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 LAXMAN BESRA |
KALINGA INSTITUTE OF MEDICAL SCIENCES,BHUBANESHWAR |
ROOM NUMBER 17,FIRST FLOOR,A BLOCK,DEPARTMENT OF DERMATOLOGY, VENEREOLOGY & LEPROSY, KALINGA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR
Khordha
ORISSA |
9500282040
laxman.derm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee, kalinga institute of medical sciences KIIT deemed to be university, bhubaneswar- 751024 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Non-tinted Sunscreen |
Non-tinted Sunscreen Local application (full face) BD in morning for 2 months |
| Intervention |
Tinted Sunscreen |
Tinted Sunscreen Local application (full face) BD in morning for 2 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
history of topical steroid use for more than 1 month |
|
| ExclusionCriteria |
| Details |
1. systemic corticosteroid use within the last 1 month
2. pregnant or lactating females |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Dermoscopy-Assisted Topical Steroid-Damaged Face Severity (DATS) score from baseline to 8 weeks between the two groups. |
0, 4 and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in Physician Global Assessment (PGA) score from baseline to 8 weeks
2. Change in Dermatology Life Quality Index (DLQI) from baseline to 8 weeks.
3. Clinical and dermoscopic photographic improvement at 4 and 8 weeks compared to baseline. |
0 and 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
11/04/2026 |
| 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="6"
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
randomized controlled trial aims to evaluate and compare the efficacy and
safety of tinted versus non-tinted sunscreens in the management of Topical
Steroid Damaged Face (TSDF). TSDF results from prolonged, unsupervised use of
topical corticosteroids on facial skin, leading to erythema, atrophy,
telangiectasia, and pigmentary changes. Photoprotection plays a crucial role in
treatment, and tinted sunscreens containing iron oxides may provide superior
protection by blocking both ultraviolet (UV) and visible light, unlike
conventional non-tinted formulations. Seventy patients diagnosed with TSDF will
be randomized into two groups: one receiving tinted sunscreen and the other
non-tinted sunscreen, both combined with emollient therapy and sun-avoidance
measures. Efficacy will be assessed using the Dermoscopy-Assisted Topical
Steroid-Damaged Face Severity (DATS) score, Physician Global Assessment (PGA),
and Dermatology Life Quality Index (DLQI) at baseline, 4 weeks, and 8 weeks. The study hypothesizes that tinted sunscreen will result in superior clinical
and dermoscopic improvement, along with better quality-of-life outcomes,
compared to non-tinted sunscreen. |