| CTRI Number |
CTRI/2025/10/096101 [Registered on: 15/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic cream] |
| Study Design |
Other |
|
Public Title of Study
|
A 15-Week Study to see how well a face cream reduces dark spots in healthy Indian women |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Spot Lightening Efficacy of a Face Care
Formulation (Face Care/Soin Visage 2039174 88) On Pigmentary Spots in Healthy Indian
Females over a period of 15 Weeks |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EV2409-0753 ID24-17217/2425CICL021, V 01 dated 22 Sep 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sneha Sonker |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
CIDP Biotech India Pvt. Ltd.
32 B, First floor, Pusa Road, Rajinder Nagar, New Delhi, India
32-B, First Floor, Pusa Road, Rajinder Nagar New Delhi
New Delhi
DELHI
110005
India |
| Phone |
9654331344 |
| Fax |
|
| Email |
s.sonker@cidp-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sneha Sonker |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
CIDP Biotech India Pvt. Ltd.
32 B, First floor, Pusa Road, Rajinder Nagar, New Delhi, India
32-B, First Floor, Pusa Road, Rajinder Nagar New Delhi
New Delhi
DELHI
110005
India |
| Phone |
9654331344 |
| Fax |
|
| Email |
s.sonker@cidp-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
HIRAK JYOTI NATH |
| Designation |
Project Manager |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
CIDP Biotech India Pvt. Ltd.
32 B, First floor, Pusa Road, Rajinder Nagar, New Delhi, India
32-B, First Floor, Pusa Road, Rajinder Nagar New Delhi
New Delhi
DELHI
110005
India |
| Phone |
08638742731 |
| Fax |
|
| Email |
h.nath@cidp-cro.com |
|
|
Source of Monetary or Material Support
|
| L’Oreal Research & Innovation
Evaluation Intelligence
188 200 Rue Paul Hochart
94550 Chevilly Larue
France |
|
|
Primary Sponsor
|
| Name |
L’Oréal Research & Innovation |
| Address |
188-200 Rue Paul Hochart
94550 Chevilly Larue
France |
| 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 |
| HIRAK JYOTI NATH |
CIDP Biotech India Pvt. Ltd. |
32-B, First Floor, Pusa Road, Rajinder Nagar New Delhi
New Delhi
DELHI |
8638742731
h.nath@cidp-cro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-GSER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants having at least one homogeneous, well-defined PIH spot of at least greater than equal to 3mm diameter on their face using vernier caliper at screening visit and baseline visit. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Face Care / Soin Visage 2039174 88 |
Administration route: Topical usage
Galenic and packaging: emulsion in a glass pack
Investigational Product Aspect: Beige cream
Physical aspect: Beige cream
Duration of intervention is 84 days for each participant. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Healthy Indian female participants aged 20 to 60 years (both inclusive) (in case of difficulty in recruiting the participants the age can be extended to 70 years; applicable for phototypes V and VI).
Participant with skin phototype ranging from III to VI according to spectrophotometer (CM-26d/CM-2600d) measurement on the unexposed area of the back on screening and baseline visit.
Participants having at least one homogeneous, well-defined PIH spot of at least greater than or equal to 3mm diameter on their face using vernier caliper at screening visit and baseline visit.
At least 20 participants with acne spot having clinical grading of with greater than or equal to 2 grades of contrast, greater than or equal to 2 grades of density and greater than or equal to 2 grades of size according to skin aging atlas, Asian skin type Volume 2, done by the investigator.
Participant of all skin types (oily, dry, combination and normal) with minimum 15 participants having oily skin self-declared by the participants and perceived by the investigator.
50 percent of the participants having sensitive skin (self-declared).
Participants agree not to undergo any permanent makeup or cosmetic surgery or apply any self-tanning tool on the investigational area during the study.
Participants agree not to apply any makeup or cosmetic product on investigational area except on lips and eyes (when required).
Participants agree to avoid excessive sun exposure and not to undergo any natural or artificial UV exposure during the study.
Participants who are informed about the study objectives and procedures, study schedule, requirements and able to understand and comply with them.
Participants willing to provide written informed consent and can read, write, and understand Hindi or English.
Participants of childbearing potential must agree to undergo urine pregnancy testing.
Participants of childbearing potential who are not sexually active or are using medically accepted contraceptive methods for at least one month before study initiation and throughout the study period.
Accepted contraceptive methods include surgical sterilization (oophorectomy, hysterectomy, tubal ligation), oral, injectable or implant hormonal contraceptives, IUDs, condoms with spermicide, diaphragm or cervical cap with spermicide. |
|
| ExclusionCriteria |
| Details |
Women who are currently pregnant, breastfeeding (lactating), or planning to become pregnant during the study period.
Participants who have started, stopped, or changed any hormonal treatment (such as contraceptive pills) within the last four weeks.
Participants who have post-inflammatory erythema (PIE) spots, solar lentigines (sunspots), or melasma.
Participants who have received any injections, undergone cosmetic surgery, or had permanent makeup on the study area within the last six months—or who are planning any such procedures during the study period.
Participants who have used any depigmenting cosmetic product, or products containing retinol (or its derivatives), vitamin C (or its derivatives), or alpha/beta hydroxy acids (AHA/BHA) on the study area within one month before the study starts.
Participants who have a known immune system disorder or any serious medical condition that, in the opinion of the investigator, could affect their safety during the study.
Participants who have recently sunbathed, used self-tanning products, visited tanning salons, undergone phototherapy, or plan to do any of these during the study.
Participants who are unable to follow study instructions or cannot be contacted in case of an emergency. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluate the efficacy of the investigational product by assessing the following parameters:
• Changes in clinical grading of contrast of selected PIH spot.
when compared with D0.
• Changes in clinical grading of density of selected PIH spot.
• Changes in the size of selected PIH spot.
• Changes in the measurement (L star, a star and b star) of the selected PIH spot, the adjacent skin and one untreated
and non-exposed zone (at the top of the buttock) using Spectrophotometer (CM-
26d or CM-2600d). |
at baseline, week 1, week 2, week 4, week 8, week 12, week 13, week 14 and week 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of the investigational product by assessing the following parameters:
• Standard facial imaging using VISIA-CR (Standard 1, Standard 2/Raked, Cross-Polarized & Parallel-
Polarized) done at D0, D28, D56 & D84 for further analysis.
• Changes in the response of Self Evaluation Questionnaire (SEQ) for product efficacy & suitability at
timepoints respectively D0 (Timm), D7, D14, D28, D56, D84, D91, D98 & D105.
• Safety assessment of investigational product by total number of SAE, AE, LI reported throughout the
study. |
at baseline, week 1, week 2, week 4, week 8, week 12, week 13, week 14 & week 15 |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/10/2025 |
| 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="4"
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
|
Study Summary
This clinical study aims to assess the effectiveness and safety of a face care product called Formulation 2039174 88 in reducing dark spots, also known as hyperpigmentation, in healthy Indian women over a period of 15 weeks.
Hyperpigmentation occurs when the skin produces too much melanin, leading to dark patches or spots. It is more common in people with medium to dark skin tones and can be caused by sun exposure, acne, skin injuries, hormonal changes, or inflammation.
Study Phases
Study Design
-
Single-center, open-label, before-and-after study
-
Participants: Healthy Indian females aged 20 to 60 years, extended up to 70 years if needed, with at least one well-defined dark spot
-
Total duration: 133 days
-
28 days washout phase
-
84 days product use
-
21 days relapse phase
Primary Objectives
Secondary Objectives
-
Capture facial images using VISIA CR imaging
-
Assess how long the product’s effects last after stopping use
-
Collect feedback from participants on skin appearance and product suitability
-
Monitor any skin irritation or side effects during the study |