| CTRI Number |
CTRI/2025/12/099386 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Facial cleanser] |
| Study Design |
Other |
|
Public Title of Study
|
An 8-Week study to see if a facial cleanser can safely reduce dark spots in asian skin |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF A FACIAL CLEANSER IN REDUCING HYPERPIGMENTATION/POST-INFLAMMATORY HYPERPIGMENTATION (PIH) IN HEALTHY ASIAN PARTICIPANTS OVER A PERIOD OF 8 WEEKS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2526CICL007,version 01dated 20 Nov 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pranami Kashyap |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
32-B, First Floor, Pusa Road, Rajinder Nagar New Delhi
32-B, First Floor, Pusa Road, Rajinder Nagar New Delhi
New Delhi
DELHI
110005
India |
| Phone |
9089348156 |
| Fax |
|
| Email |
p.kashyap@cidp-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranami Kashyap |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
32-B, First Floor, Pusa Road, Rajinder Nagar New Delhi
32-B, First Floor, Pusa Road, Rajinder Nagar New Delhi
DELHI
110005
India |
| Phone |
9089348156 |
| Fax |
|
| Email |
p.kashyap@cidp-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Vidushi Bazaz |
| Designation |
Project Manager |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
32-B, First Floor, Pusa Road, Rajinder Nagar New Delhi
New Delhi
DELHI
110005
India |
| Phone |
9873348229 |
| Fax |
|
| Email |
v.bazaz@cidp-cro.com |
|
|
Source of Monetary or Material Support
|
| L’Oréal Research & Innovation;30 Terminal Avenue, Clark, NJ 07066 |
|
|
Primary Sponsor
|
| Name |
L’Oréal Research & Innovation |
| Address |
30 Terminal Avenue, Clark, NJ 07066 |
| Type of Sponsor |
Other [Cosmetic research organisation] |
|
|
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 Pranami Kashyap |
CIDP Biotech India Pvt. Ltd. |
32-B, First Floor, Pusa Road, Rajinder Nagar New Delhi
New Delhi
DELHI |
09089348156
p.kashyap@cidp-cro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GSER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants presenting hyperpigmentation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CERAVE BRIGHTENING CLEANSER |
COCO-BETAINE, DISODIUM LAURETH, SULFOSUCCINATE
SODIUM LAUROYL, SARCOSINATE, NIACINAMIDE
LACTIC ACID, GLYCERIN, LAURETH-4, SALICYLIC ACID, POTASSIUM HYDROXIDE
Product: Facial cleanser (Cerave Brightening Cleanser) (Fla No 2051721 13)
Application site and frequency: Full Face (Morning and Evening)
Dosage: Adequate amount required to apply
Administration Mode: Twice a day: morning and night Massage cleanser into wet skin and rinse. Avoid eye area. In case of contact with eyes rinse immediately
|
| Comparator Agent |
None |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy Asian male and female participants aged 18 to 55 years inclusive. At least 33 percent minimum 20 participants must be male.
2.Male and female participants must have very light to no facial hair and agree to keep facial hair the same throughout the study. No moustache or goatee allowed.
3.Participants must have a self perceived skin type with at least 10 percent representation of each type including normal, normal to oily, combination, and oily skin.
4.At least 50 percent of participants must have self perceived sensitive skin.
5.Participants with mild to moderate clinical grading score 3 to 6 according to a modified Griffiths scale for the whole face for
Skin tone evenness
Global discoloration or hyperpigmentation
Global stubborn dark spots including PIH PIE as hyperpigmentation for low phototypes sunspots age spots and general dark spots
Rough skin texture visual smoothness
Rough skin texture tactile softness
Skin clarity
Brightness or radiance
Enlarged pores
Overall skin appearance or quality skin health
6.Participants must have at least one homogeneous well defined stubborn dark spot of at least 3 mm diameter on the face measured using a vernier caliper at screening and baseline visits.
7.Participants must self perceive the following concerns on the face
Rough skin texture
Dull skin
Dark spots or hyperpigmentation
Uneven skin tone
Visible pores
8.Participants with Phototype II to VI as per ITA classification measured using Chromameter CR 400 on the back.
N 5 for phototype II and III
N 25 for phototype IV
N 25 for phototype V
N 5 for phototype VI
9.Participants willing to avoid UV sessions sun tanning sun bathing or any extensive sun exposure during the study.
10.Participants agree to facial waxing or threading one to two days prior to study visits.
11.Participants who use makeup three to seven times a week.
12.Participants who have been using the same skin care and makeup products for at least one month prior to study start.
13.Participants who use SPF five to seven times a week.
14.Participants who use face wash and moisturizer one to two times a day and five to seven times a week.
15.Participants willing to avoid any oral or topical medications that may interfere with study results.
16.Participants must agree to replace their own cleanser and use only the investigational facial cleanser and the provided SPF during the study.
17.Participants must be using a non anti aging cleanser one to two times a day five to seven times a week.
18.Participants able to read write and understand the informed consent document and willing to sign it.
19.Participants willing and able to follow study requirements instructions and schedule.
20.Females of childbearing potential must self declare not pregnant at screening and undergo urine pregnancy tests at Baseline Day 0 Day 28 and Day 56.
21.Females of childbearing potential must either not be sexually active or must use an effective contraceptive method except systemic contraception for at least one month before the study and throughout the study. Effective methods include
Surgical sterilization such as oophorectomy hysterectomy or tubal ligation
Oral implant or injection contraceptives
Diaphragm or cervical cap with intravaginal spermicide
Intravaginal device
Intrauterine device
Condom with spermicide |
|
| ExclusionCriteria |
| Details |
1. Participants with any facial permanent makeup or tanning on evaluation areas during the study period.
2. Participants who have undergone any aesthetic surgery on evaluation areas.
3. Participants with moderate to severe melasma.
4. Use of depigmenting retinol vitamin C or AHA based products on evaluation areas within one month.
5. Participants using self tanning products on evaluation areas within one month.
6. Participants using other cosmetic products on evaluation areas within 24 hours before the screening visit.
7. Participants who started hormone replacement therapy or hormonal birth control less than three months before study entry or who plan to start stop or change doses during the study.
8. Participants with any skin condition that may interfere with efficacy evaluation in the investigators opinion.
9. Participants who are pregnant lactating or planning pregnancy during the study.
10. Participants with a history of allergy or hypersensitivity to ingredients of the investigational product.
11. Participants with significant skin pathology in test areas such as rosacea severe acne or eczema.
12. Participants with any significant medical condition that may interfere with study participation.
13. Participants with medical or surgical conditions or medication use that may harm them or interfere with assessments.
14. Participants using topical or systemic treatments that may interfere with the study such as corticosteroids retinoids anti inflammatory drugs or anti aging products.
15. Participants who had dermatological or anti aging procedures such as laser peel dermabrasion photo rejuvenation or facial peeling within six months before study start or during the study.
16. Participants who participated in another clinical study within one month before screening or are currently participating in another study.
17. Participants who cannot be contacted by phone in case of emergency.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the changes in facial skin during the study duration using a modified Griffiths scale 0 equals none 9 equals severe based on clinical grading by the Investigator for the following parameters
• Skin tone evenness
• Global discoloration hyperpigmentation
• Global stubborn dark spots including PIH PIE as hyperpigmentation for low phototypes sunspots age spots and general dark spots
• Rough skin texture visual smoothness
• Rough skin texture tactile softness
• Skin clarity
• Brightness radiance
• Enlarged pores
• Overall skin appearance quality skin health
|
Day 0, Day 3, Day 7, Day 14, Day 28, Day 42, Day 56
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Instrumental assessments using Chromameter 400, Skin Cam Pro, VISIA CR |
Day 0, Day 3, Day 7, Day 14, Day 28, Day 42, Day 56 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
29/12/2025 |
| 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="2"
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 is a monocentric, open-label, 8-week efficacy and
tolerability study evaluating a facial cleanser designed for people with
hyperpigmentation, conducted on Asian adults (18–55 years). A total of 60
participants will be enrolled to achieve at least 50 study completers, with at
least 33% males.
Participants will use the investigational cleanser twice
daily for 8 weeks and attend eight study visits:
D0 (including immediate and 8-hour assessments), D3, D7, D14, D28, D42, and D56
(with allowable visit windows).
|