| CTRI Number |
CTRI/2026/02/102879 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Topical product for Eczema] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate efficacy and safety of test product on participants with mild to moderate eczema. |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Efficacy and Safety of the Test Product in Adult Male and Female Participants with Mild to Moderate Eczema |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B06716; Version: 01, Dated 08 Jan 26 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhagirath Patel |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054. Phone: 07966135601
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825618138 |
| Fax |
|
| Email |
bpatel3@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Simran Sethi |
| Designation |
Senior Director-Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054. Phone: 07966135601
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
|
| Email |
ssethi@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Parth Joshi |
| Designation |
Overall Study Coordinator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department, Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
|
| Email |
pjoshi@cliantha.com |
|
|
Source of Monetary or Material Support
|
| Cliantha Research, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054, Gujarat, India |
| Winnox Cosmeceutics (Wipro Consumer Care), No. 7, Persiaran Subang Permai, Taman Perindustrian Subang, 47610 Subang Jaya Selangor Darul Ehsan, Malaysia |
|
|
Primary Sponsor
|
| Name |
Winnox Cosmeceutics (Wipro Consumer Care) |
| Address |
No. 7, Persiaran Subang Permai, Taman Perindustrian Subang, 47610 Subang Jaya Selangor Darul Ehsan, Malaysia |
| Type of Sponsor |
Other [Cosmetic and Personal Care] |
|
|
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 Bhagirath Patel |
Cliantha Research |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off Sindhubhavan Road,
Nr. Mann Party Plot Cross Road,
Bodakdev, Ahmedabad-380054, Gujarat.
Phone# 07966135601
Ahmadabad
GUJARAT |
9825618138
bpatel3@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM - Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mist Spray |
1 spray of the product will be used twice daily (morning and evening) on lesion site starting from Day 01 to Day 28. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Participants diagnosed with Mild to Moderate Eczema (score between 2 - 8) based on Atopic Dermatitis Severity Index (ADSI)
2) Participants with itchy skin.
3) Participants with at least one prominent lesion.
4) Participants having good general health and free of any disease state or physical condition that might impair evaluation which in the Investigators opinion, exposes the participant to an unacceptable risk by study participation
5) Female participants of childbearing potential must have a negative urine pregnancy test at enrollment visit. |
|
| ExclusionCriteria |
| Details |
1) Participants with serious skin conditions like psoriasis, Uraemic pruritus, etc.
2) Presence of any medical condition or disability that could interfere with study.
3) Participants with any clinically significant systemic disease.
4) Participants having known allergy to active ingredient/raw material of the test product.
5) Presence of any cutaneous condition on test site that could interfere with study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Dermatological assessment for severity of eczema
2) Assessment of Skin Itchiness |
1) Day 01 i.e., baseline (before product application) to after application on Day 01 [at 30 mins, 04 hours, 06 hours and 08 hours] and Day 28.
2) Day 01 i.e., baseline (before product application) to after application on Day 01 [10 secs, 20 secs, 30 secs, 40 secs, 50 secs, 60 secs, 02 mins, 30 mins, 04 hours, 06 hours and 08 hours] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Instrumental Assessment for skin barrier function by measuring Transepidermal Water Loss (TEWL) |
Day 01 i.e., baseline (before product application) to after application on Day 01 [at 30 mins, 04 hours, 06 hours and 08 hours] and Day 28. |
| Instrumental Assessment for skin erythema (anti-redness effect) |
Day 01 i.e., baseline (before product application) to after application on Day 01 [at 30 mins, 04 hours, 06 hours and 08 hours] and Day 28. |
| Subjective Evaluation Questionnaire |
Day 01 i.e., baseline (before product application), 08 hours post product application on Day 01 and Day 28. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
14/02/2026 |
| 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="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
|
This is an open label, non-randomized,
single-arm interventional clinical study to evaluate the efficacy and safety of
the test product in Adult Male and Female Participants with Mild to Moderate
Eczema.
The potential participants will be screened as
per the inclusion and exclusion criteria only after obtaining written informed
consent from the participants.
All eligible participants will undergo clinical
evaluation by a Dermatologist, instrument evaluation and subjective evaluation.
Safety will be assessed throughout the study by monitoring adverse events. |