| CTRI Number |
CTRI/2025/07/090488 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| 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 of Test Product in reducing appearance of wrinkles, expression lines and dark spots. |
|
Scientific Title of Study
|
A clinical study to evaluate cosmetic efficacy and safety of an antioxidant serum in reducing appearance of wrinkles, expression lines and dark spots in healthy adult participants. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B05863; Version: 01, Dated 12 Jun 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 Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054. Phone# 079 66135601
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# 079 66135601
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
|
| Email |
ssethi@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parth Joshi |
| Designation |
Sub - 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# 079 66135601
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. |
| KAYURA EFFECT LLP, 11th Floor, Salister Building, B/h Rajpath Club, SG Highway, Ahmedabad 380054, Gujarat India. |
|
|
Primary Sponsor
|
| Name |
KAYURA EFFECT LLP |
| Address |
11th Floor, Salister Building, B/h Rajpath Club, SG Highway, Ahmedabad 380054, Gujarat India. |
| Type of Sponsor |
Other [FMCG] |
|
|
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# +91-79-66135601
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 males and females with fine line/wrinkles, dark spots and uneven skin tone. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Serum |
Sufficient quantity of serum will be applied on entire face, gently massaged till the serum gets completely absorbed.
Twice daily application for 2 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy adult males and non-pregnant/non-lactating females with age 30 to 55 years (both inclusive at the time of consent).
2. Participants having fine line/wrinkles score of “1” (Occasional number of fine lines widely spaced) or “2” (Few number of discreet fine lines) as per Physician Global Assessment (PGA).
3. Participants with at least 2 dark spots on the face.
4. Participants with uneven skin tone and with dull skin.
5. Participants having good general health as determined by the Investigator on the basis of medical history.
6. Participants of childbearing potential must have a negative urine pregnancy test performed at screening/enrollment visit. |
|
| ExclusionCriteria |
| Details |
1. Participants having any active dermatological skin conditions (e.g., acne, eczema, psoriasis, rosacea etc.), that might interfere with clinical assessments.
2. Participants having excessive hair, moles, open wounds, cuts, abrasions, irritation symptoms, tattoos, scars, sunburn or any dermatological condition on the test site(s) that can interfere with the reading.
3. Participants who are receiving topical or systemic treatments for fine line/wrinkles and pigmentation.
4. Participants are unwilling to avoid unprotected sun or other UV radiation exposure during the study period.
5. Chronic illness which may influence the cutaneous state.
6. Participants with known allergy or sensitivity to cosmetic products and/or any ingredients of the test product.
7. Participants having a history of diabetes, acute cardiac and circulatory diseases, HIV, hepatitis.
8. Participants with history of drug and alcohol abuse.
9. Any other condition which could warrant exclusion from the study, as per the Dermatologist’s/investigator’s discretion.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dermatological assessment of fine line/wrinkles and coarse wrinkling/lines |
Day 00, Day 15, Day 30, Day 45 and Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dermatological assessment of skin tone evenness |
Day 00, Day 15, Day 30, Day 45 and Day 60 |
| Instrumental assessment of skin lightening, skin gloss/radiance, fine lines/wrinkles, dark spots and skin texture |
Day 00, Day 15, Day 30, Day 45 and Day 60 |
| Participant Satisfaction Questionnaire |
Day 15, Day 30, Day 45 and Day 60 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
30/07/2025 |
| 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="3"
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-centre, single arm clinical study to evaluate cosmetic efficacy and
safety of an antioxidant serum in reducing appearance of wrinkles, expression
lines and dark spots in healthy adult 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. |