| CTRI Number |
CTRI/2025/09/095413 [Registered on: 25/09/2025] Trial Registered Prospectively |
| Last Modified On: |
25/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the efficacy and safety of the test product on the tanned skin. |
|
Scientific Title of Study
|
A clinical study to evaluate the effectiveness of the test product on the tanned skin along with its safety on healthy adult female participants. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B06105; Version: 01, Dated 01 Sep 25 |
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 Rd, Nr. Mann Party Plot Crossroad,
Bodakdev, Ahmedabad-380054. Phone# 07966135601
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825618138 |
| Fax |
|
| Email |
bpatel3@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Mori |
| Designation |
Medical Monitor |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off Sindhubhavan Rd, Nr. Mann Party Plot Crossroad,
Bodakdev, Ahmedabad-380054. Phone# 07966135601
Ahmadabad
GUJARAT
380054
India |
| Phone |
9773262487 |
| Fax |
|
| Email |
damori@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 Rd, Nr. Mann Party Plot Crossroad,
Bodakdev, Ahmedabad-380054. Phone# 07966135601
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. |
| Zydus Wellness Products Limited, Plot No 115/5 TP Scheme No 51, Beside Bliss Apartment,
Opp Viola Apartment, Ambli Bopal Road, Ahmedabad 380015
|
|
|
Primary Sponsor
|
| Name |
Zydus Wellness Products Limited |
| Address |
Plot No 115/5 TP Scheme No 51
Beside Bliss Apartment, Opp Viola Apartment,
Ambli Bopal Road, Ahmedabad 380015. |
| Type of Sponsor |
Other [Health and Hygiene] |
|
|
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.
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 |
| Healthy Human Volunteers |
Healthy participants with visible tanned skin. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CL-TRFW-25 |
Approx. 1 gm of product will be applied twice a week during the entire study duration. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1) Non-pregnant /non-lactating females.
2) Participants with fitzpatrick skin type IV and V.
3) Participants with visible skin tan on face, at least 2 shade darker than a Sun protected upper volar arm.
4) Participants with visible blackheads on the face.
5) Participants with at least 2 blemishes.
6) Participants who are willing to voluntarily participate in the study and provide signed informed consent.
|
|
| ExclusionCriteria |
| Details |
1) Participants with dark facial skin as determined by dermatologist.
2) Participants having any active dermatological skin diseases (e.g., psoriasis, atopic dermatitis, rosacea etc.), that might interfere with clinical assessments.
3) Participants using any other facewash during the study period.
4) Participants using other marketed skin lightening products during the study period or in the past 6 weeks.
5) Participants who are receiving topical or systemic treatments for pigmentation within the last 30 days.
6) Participant undergoing treatment for Seborrhoea, Acne, Dermatitis, Melasma, Lentigines, skin Lightening/ any other cosmetic/ dermatologic skin condition on face. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of test product on tanned skin, based on instrumental evaluations. |
Day 01 (Before and after product usage) , Day 03, Day 07, Day 14 and Day 21. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of test product on tanned skin, based on clinical, instrumental and subjective evaluations. |
Day 01 (Before and after product usage) , Day 03, Day 07, Day 14 and Day 21. |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
22/10/2025 |
| 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="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-center, single-arm clinical study to evaluate the effectiveness of the
test product on the tanned skin along with its safety on healthy adult female
participants.
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. |