| CTRI Number |
CTRI/2026/01/102546 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
01/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [cosmetic] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A two-week clinical study to evaluate the skin safety of a face cream used after light-based and microneedling procedures in adult women |
|
Scientific Title of Study
|
A Single Center, 2 weeks, Clinical Trial to Evaluate the Tolerability of a Topical Face Cream When Used Post- Intense Pulsed Light (IPL) and Post-Microneedling on Adult Females. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/JJSS/2025-02; CS2025SK100293 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
327/15,1st Main Road, Cambridge
Layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Vidya Nair |
| Designation |
Principal Scientist Clinical Research/ Study Director |
| Affiliation |
[KENVUE],JNTL Consumer Health (India) Private Limited |
| Address |
Lal Bahadur Shashtri Marg ; West Mulund; Mumbai
Mumbai
MAHARASHTRA
400080
India |
| Phone |
9892286965 |
| Fax |
|
| Email |
vidyan1@kenvue.com |
|
Details of Contact Person
Public Query
|
| Name |
Sudhanthiran S |
| Designation |
manager- Techno commercial |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
324, Second Floor, 1st Main Road, Cambridge Layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
sudhan@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Kenvue Brands LLC.
1 Kenvue Way, Summit, NJ 07901, USA |
|
|
Primary Sponsor
|
| Name |
Kenvue Brands LLC. |
| Address |
1 Kenvue Way, Summit, NJ 07901, USA |
| 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 Mukta Sachdev |
MS Clinical Research Pvt. Ltd |
327/15,1st Main Road, Cambridge
Layout, Ulsoor
Bangalore
KARNATAKA |
08040917253
mukta.sachdev@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE INDEPENDENT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy female trial participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Face Cream- F 444-057 |
A pea size amount of the Face Cream applied on the full face twice per day for 2 weeks. |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
a) Female
b) 25 to 70 years old
c) Fitzpatrick Skin Type III, IV, V, or VI
d) More than 6 participants in IPL treatment group must undergone IPL and 6 participants in Microneedling group must undergone Microneedling treatment in the past 1-6 months before the study.
e) Generally, in good health based on medical history reported by the trial participant.
f) Able to read, write, speak, and understand English or Kannada.
g) Willing to sign the Consent for Photograph Release.
h) Intend to complete the study and is willing and able to follow all study instructions
|
|
| ExclusionCriteria |
| Details |
a) Has known allergies or adverse reactions to common topical skincare product ingredients used in the investigational product or ancillary products or supplies such as latex or adhesives.
b) Has undergone a facial peel, intense pulsed light treatment, microneedling, or any other professional facial treatment within 30 days prior to Visit 1.
c) Has used a topical retinol treatment within 7 days prior to Visit 1.
d) Presents with any skin condition that may confound study results, including but not limited to active skin infections, photosensitive disorders or use of photosensitizing medications, history of keloids, psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer.
e) Has self reported Type 1 or Type 2 diabetes or is currently taking insulin or any other anti diabetic medication.
f) Is taking any medication that may mask an adverse event or confound study results, including immunosuppressive or steroidal drugs within 2 months prior to Visit 1 or during the study, antihistamines within 2 weeks prior to Visit 1 or during the study, or non steroidal anti inflammatory drugs within 5 days prior to Visit 1 or during the study. Individuals taking these medications will not be considered eligible at screening. If a participant initiates any of these medications during the study, the Principal Investigator will be consulted to assess the impact on participant safety and study outcomes in accordance with concurrent or concomitant medication guidelines.
g) Is self reported to be pregnant or planning to become pregnant during the study period.
h) Has a history of or a concurrent medical or other condition that may place the individual at significant risk, confound study results, or significantly interfere with participation in the study.
i) Is currently participating in another clinical study or has participated in any product use study within 30 days prior to Visit 1.
j) Is an employee or contractor of the Principal Investigator, study site, or sponsor, or an immediate family member of any of these individuals. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the tolerability of an investigational face cream when used after a post POST INTENSE PULSED LIGHT (IPL) and/OR microneedling procedures in female trial participants. |
Day 0, Hour 48, Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/02/2026 |
| Date of Study Completion (India) |
11/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
11/03/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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 single center, monadic clinical study designed to evaluate the safety and tolerability of a facial cream in female participants aged 25 to 70 years who are generally in good health. A sufficient number of participants will be screened to ensure that at least 24 participants complete the study. At least six participants must have undergone Intense Pulsed Light treatment and at least six participants must have undergone microneedling treatment within 1 to 6 months prior to study participation.
The study includes four visits. Visit 1 is a screening visit conducted 3 to 5 days prior to Visit 2. Visit 2 is conducted on Day 0 and includes baseline assessments, Intense Pulsed Light or microneedling procedures, and supervised application of the investigational product. Visit 3 is conducted approximately 48 hours after Visit 2, and Visit 4 is conducted on Day 14.
At the screening visit, participants will be provided with a facial cream to replace their usual facial products. Following the procedure at Visit 2, participants will apply the investigational product under supervision and will continue application at home as instructed. Between Visit 3 and Visit 4, participants will use a facial cleanser and apply the study cream twice daily, with sunscreen use in the morning.
Safety and tolerability assessments will be conducted throughout the study duration. |