| CTRI Number |
CTRI/2026/02/104874 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Interventional Trial to Evaluate a Test Product for Sensitive and Oily Skin Barrier Repair] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study to Evaluate the Safety and Effectiveness of a Test Product in Sensitive and Oily Skin |
|
Scientific Title of Study
|
A RANDOMISED MULTICENTRIC PARALLEL GROUP STUDY TO EVALUATE THE TOLERANCE AND EFFICACY OF TEST PRODUCT ON SENSITIVE AND OILY SKIN IN SKIN BARRIER REPAIR |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2526CICL026/ 2526CBCL035 version 01 dated 11 Feb 2026 |
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
32B First floor and Second Floor Pusa Road Rajinder Nagar
New Delhi India
Central
DELHI
111005
India |
| Phone |
09654331344 |
| 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
32B First floor and Second Floor Pusa Road Rajinder Nagar
New Delhi India
DELHI
111005
India |
| Phone |
09654331344 |
| Fax |
|
| Email |
s.sonker@cidp-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Vidushi Bazaz |
| Designation |
Project Manager |
| Affiliation |
CIDP Biotech India Pvt Ltd |
| Address |
CIDP Biotech India Pvt Ltd
32B First floor and Second Floor Pusa Road Rajinder Nagar
New Delhi India
Central
DELHI
110005
India |
| Phone |
9873348229 |
| Fax |
|
| Email |
v.bazaz@cidp-cro.com |
|
|
Source of Monetary or Material Support
|
| Loreal Research and Innovation, L’Oreal CeraVe DMI
10 Hudson Yards
New-York, USA |
|
|
Primary Sponsor
|
| Name |
Loreal Research and Innovation |
| Address |
Loreal CeraVe DMI
10 Hudson Yards
New York USA |
| 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 Sneha Sonker |
CIDP Biotech India Pvt Ltd |
CIDP Biotech India Pvt Ltd
32B First floor and Second Floor Pusa Road Rajinder Nagar
New Delhi India
Central
DELHI |
09654331344
s.sonker@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 with sensitive and oily skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Foaming cleanser and Gel cream |
For Foaming cleanser: The investigational product is Foaming cleanser.
The Batch Numbers is B52492315C &
58Y96V.
The product is intended for topical administration.
The physical appearance of the product is clear gel.
Ingredients: AQUA/WATER, COCAMIDOPROPYL HYDROXYSULTAINE, GLYCERIN, SODIUM LAUROYL SARCOSINATE, PROPANEDIOL, PEG-150 PENTAERYTHRITYL TETRASTEARATE, NIACINAMIDE, PEG-6 CAPRYLIC/CAPRIC GLYCERIDES, CERAMIDE NP, CERAMIDE AP, CERAMIDE EOP, CARBOMER, SODIUM METHYL COCOYL TAURATE, SODIUM BENZOATE, SODIUM CHLORIDE, SODIUM LAUROYL LACTYLATE, SODIUM HYALURONATE, CHOLESTEROL, PHENOXYETHANOL, DISODIUM EDTA, CITRIC ACID, TETRASODIUM EDTA, PHYTOSPHINGOSINE, XANTHAN GUM, ETHYLHEXYLGLYCERIN.
For Gel cream: The investigational product is a Gel Cream with Formula Code 2021650 31 and Batch Number B 54Y501.
It is intended for topical administration.
The physical appearance of the product is an opaque gel cream.
Ingredients: AQUA / WATER, NIACINAMIDE ,GLYCERIN , CETEARYL ISONONANOATE , C14-22 ALCOHOLS , ISOPROPYL MYRISTATE , ZEA MAYS STARCH / CORN STARCH , CERAMIDE NP , CERAMIDE AP , CERAMIDE EOP , CARBOMER , CETEARYL ALCOHOL , BEHENTRIMONIUM METHOSULFATE , TRIETHYL CITRATE , SILICA , SODIUM HYDROXIDE , SODIUM HYALURONATE , SODIUM LAUROYL LACTYLATE , CHOLESTEROL , PHENOXYETHANOL , CITRIC ACID , CAPRYLYL GLYCOL , TRISODIUM ETHYLENEDIAMINE DISUCCINATE , XANTHAN GUM , PHYTOSPHINGOSINE , POLYACRYLATE CROSSPOLYMER-6 , BENZOIC ACID , C12-20 ALKYL GLUCOSIDE
|
| Comparator Agent |
Harsh soap and gel cream |
Harsh Soap (Classic scent coast deodorant soap)
Batch No: L2529987BB0929 & L2535574BB1029
Administration route:
Topical
Physical aspect:
Bar
For Gel cream: The investigational product is a Gel Cream.
Formula Code 2021650 31 and Batch Number B 54Y501.
It is intended for topical administration. The physical appearance of the product is an opaque gel cream.
Ingredients: AQUA / WATER, NIACINAMIDE ,GLYCERIN , CETEARYL ISONONANOATE , C14-22 ALCOHOLS , ISOPROPYL MYRISTATE , ZEA MAYS STARCH / CORN STARCH , CERAMIDE NP , CERAMIDE AP , CERAMIDE EOP , CARBOMER , CETEARYL ALCOHOL , BEHENTRIMONIUM METHOSULFATE , TRIETHYL CITRATE , SILICA , SODIUM HYDROXIDE , SODIUM HYALURONATE , SODIUM LAUROYL LACTYLATE , CHOLESTEROL , PHENOXYETHANOL , CITRIC ACID , CAPRYLYL GLYCOL , TRISODIUM ETHYLENEDIAMINE DISUCCINATE , XANTHAN GUM , PHYTOSPHINGOSINE , POLYACRYLATE CROSSPOLYMER-6 , BENZOIC ACID , C12-20 ALKYL GLUCOSIDE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 Healthy male and female participants aged 18 to 55 years both inclusive
2 Participants having 100 percent self perceived oily skin
3 Participants having skin sensitivity confirmed through Baumann sensitivity skin questionnaire BSSQ
4 Participants having 50 percent positive to LAST Lactic acid stinging test
5 Participants with Phototype I to VI with at least 5 participants of each phototype II to V and at least 3 participants each of phototype I and VI based on ITA classification measured using Chromameter CR 400 on back of participants
Phototype distribution across both countries
India
Phototype Grouping
N 25 for phototype Type IV
N 19 for phototype Type V
N 6 for phototype Type VI
Brazil
N 5 for phototype Type I
N 7 for phototype Type II
N 38 for phototype Type III
6 Participants willing not to go for UV sessions sun tanning sun bathing or any sun exposure during the study duration
7 Participants who are SPF users may be included
8 Participants using their own non treatment sunscreen without antiaging or oil control claims may continue their usual product provided it has been used consistently for at least 1 month prior to study inclusion Participants willing to avoid use of any oral or topical medications which may interfere with the study results
9 Participants must agree to use their own SPF if non treatment SPF user and be willing to use only the investigational and auxillary product provided throughout the study duration
10 Participants who can read write and understand the informed consent document in their preferred language and are willing to give written informed consent
11 Participants willing and able to fulfil the study requirements follow instructions and study schedules
12 Female of childbearing potential self declaration pregnancy at screening visit and willing to undergo urine pregnancy test to be done at D0
13 Female of childbearing potential who is not sexually active or who is using an effective contraceptive method except systemic contraception for at least one month before the beginning of the study and throughout the study and also the contraceptive method must remain unchanged for at least 3 months prior to baseline |
|
| ExclusionCriteria |
| Details |
1 Participants with any facial permanent make up or tanning on the evaluation areas within one month prior to study initiation or during the study period
2 Participants using other cosmetic products on evaluation areas within 24 hours before screening visit
3 Participants who started hormone replacement therapies HRT or hormones for birth control less than 1 month prior to study entry or who plan on starting stopping or changing doses of HRT or hormones for birth control during the study
4 Participants with skin or any other medical condition that in opinion of investigator may interfere with the efficacy evaluation in study
5 Participants who are pregnant or lactating or who are planning to become pregnant during the study
6 History of allergies or hypersensitivity to any cosmetic ingredients of the investigational product
7 Any significant skin pathology in the test areas like rosacea severe acne eczema psoriasis or any active dermatological condition on face severe acne or eczema under the opinion of the investigator which can conflict with the study results
8 Any concomitant medical or surgical condition or using medication which may harm the participants or may interfere with the study assessments in the opinion of the investigator
9 Any topical or systemic treatment except their own SPF sunscreen that could interfere with the study treatments or assessments in the opinion of the investigator within 4 weeks prior to the screening visit
10 Any dermatological or facial procedure or aesthetic surgery laser peel microdermabrasion photo rejuvenation facial peeling etc taken 4 weeks before the start and during the study
11 Having participated in the last 1 month before screening or currently participating in another clinical or cosmetic study
12 Participants with inability to understand or follow study instructions
13 Unable to be contacted by phone in case of emergency |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 TEWL measurements using Tewameter on either left or right cheek
2 To evaluate and compare skin comfort by measuring subjective skin tolerence Burning Itching Tightness Dryness and Stinging |
V1 Screening visit minus 14 to minus 1 Washout phase
V2 Baseline visit Day 0 plus minus 2 Days Treatment Phase
V3 Evaluation visit Day 14 plus minus 2 Days End of study visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To evaluate and compare participant perception of comfort soothing and overall satisfaction of the product through self evaluation questionnaires
2 To evaluate and compare investigator objective signs of irritation Erythema Dryness Scaling peeling Edema
3 To evaluate and compare skin sebum levels using Sebumeter on centre of forehead
4 To assess skin redness and tone uniformity using VISIA CR Color Face imaging at all study visits
5 To evaluate product safety based on adverse event monitoring throughout the study duration
6 Skin hydration using Corneometer on either left or right cheek bone |
V1 Screening visit minus 14 to minus 1 Washout phase
V2 Baseline visit Day 0 plus minus 2 Days Treatment Phase
V3 Evaluation visit Day 14 plus minus 2 Days End of study visit |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/04/2026 |
| 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="0"
Days="28" |
|
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 multicentric randomized double blind parallel group before and after use efficacy study conducted in India and Brazil. The study will include 100 healthy male and female participants 50 in India and 50 in Brazil with at least 90 completers 45 per group.
Participants will be randomized in chronological order using a statistician prepared list stratified by LAST status positive or negative into two groups
Group 1 Gel Cream plus Harsh Soap
Group 2 Foaming Cleanser plus Gel Cream
All products will be applied twice daily for two weeks. During the washout phase all participants will use Harsh Soap. After washout Harsh Soap will be continued only in Group 1 until study completion. |